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Group based exercise in the management of fibromyalgia

Fibromyalgia (FM) is a condition which is linked with chronic widespread pain and multiple tender areas to palpation (Wolfe et al, 1990). It is also linked with fatigue, major physical disability, headaches, depression, social isolation, anxiety and high levels of dependence on the health system (Gran, 2003). The incidence of FM in the population varies from 0.5% to 5.8% (Croft, 2002; Gran, 2003). It is reported to affect women more commonly than men at a ratio of approximately 9:1 (Wolfe et al, 1993).

The role of exercise in the management of this condition is encouraged (Hauser et al, 2010). The European League against Arthritis (EULAR) released guidelines for the treatment of Fibromyalgia (Carville et al 2008). Unfortunately they could only give general recommendations for the use of exercise as the research, up to the end of 2005, (the parameter they used), was classed as poor.

The use of group based supervised exercise classes is used in Physiotherapy for the management of many conditions and are recommended when compared to home exercise programmes and individual treatments for some conditions (NICE, 2009). This approach has also been shown to have positive effects psychologically, even over a year after treatment has stopped (Mannion et al 2001).

Justification for the topic – FM is a condition which health professionals find difficulty in treating effectively (Sim et al, 2003). The aim of this assignment is to appraise the research on group based supervised exercise for the treatment of FM and to assess its physical, functional and psychological impact on subjects. This will be done by appropriate critical analysis of the most recent evidence on this subject. One objective of this work is to inform practice and improve the qualty of service for people suffering with FM.

Search Strategy:

Major databases were used in the literature search. These include Ovid, Medline, Pubmed, PEDRO and the Cochran Database. The search was limited to human subjects.

Keywords included were Fibromyalgia, exercise, group, supervised, pain, chronic pain, rehabilitation, management, programmes and physiotherapy.

The search was limited to studies between the years of 2005 to the present. To ensure that only the most recent and up to date research was included. Backward chaining was used at this point to obtain further relevant articles.

The research will be critiqued using the Critical Appraisal Skills Tool (CASP). HYPERLINK NEEDED. The literature review will use only high level A category Randomizes Control Trials (RCT) research papers as stated by the Oxford centre of evidence based medicine. HYPERLINK NEEDED

Literature Review

Kingsley et al, (2005) investigated the effects of a twelve week strength training programme on the function and strength of women who had been diagnosed with FM.

Thirty-five women were assessed for eligibility. Six were excluded for not meeting the inclusion criteria and 4 refused to participate. Of the 29 remaining, 15 were randomized into the strength-training group and 14 were allocated to a control group. This study was a single-blind randomized control trial as the allocation was not concealed, neither subjects nor therapists were blinded to treatment but assessors were. The process of blinding is to negate the possibility of assessment bias. One should always be attempted to blind the assessor, clinician and participant – but as it would be very difficult to produce a sham treatment in the experiment in question, I am confident in its reliability.

The intervention group took part in a 12 week programme of 11 exercises which were performed twice a week. All exercises were between 8 to 12 repetitions. The intensity of exercise was at 40% of the group’s maximal lift at the start, but this was increased to 80% over the course of the programme. All exercise sessions took approximately 30 minutes to complete. A nautilus machine was used to measure the groups maximum lift. Testing was performed in a laboratory in Florida University and the exercise component was undertaken in a wellness centre.

The control group were asked to perform with their normal activities but were told they would be given the opportunity to participate in a strength programme at the end of the programme.

The initial data was collected over a two week period. Strength in the upper and lower body was assessed using a nautilus machine.

Tender points and muscular pain were assessed by a Rheumatologist. The Rheumatologist was blind to which group the individuals had been assigned.

The Fibromyalgia Impact Questionnaire (FIQ) was used to assess the general impact of Fibromyalgia on all aspects including functional and emotional factors.

Physical function was assessed by using the Continuous-Scale Physical Functional Performance (CS-PFP).This includes sixteen functional tasks which are measured in either time to complete or distance covered.

Other tests were examined including blood pressure; heart rate and Ratings of Perceived Exertion (RPEs) were also recorded after each task.

Unfortunately, of the 29 subjects who started the research only 20 completed. This corresponds to a 31% drop-out. Of these drop outs only 2 occurred in the control group and 8 occurred in the strength group. This means that nearly half of the strength group did not complete the trial. Reasons were given for this. The author attempted to combat this by including an Intention To Treat (ITT) analysis so as to minimise bias (Petrie 2009). This approach analyses the data on everyone within the group whether they finish the trial or not.

One way analysis of variance (ANOVA) was used to examine the possibility of difference in the baseline information. The same test was used when examining baseline and results at the end of 12 weeks. ANOVA is regarded as a robust analysis tool when comparing the differences within multiple groups. There was no significant difference between baseline measurements of the control and strength group, so a direct comparison could be made and thereby strengthening results.

There was no calculation of a power score within the research. A power score is a calculation of the sample size needed to give a credible chance that the results are not due to chance. This will limit the credibility of the research.

This study discovered significant differences in lower and upper body strength between the 2 groups, favouring the strength group at level of p=0.05. At this confidence level we know that there is a 95% chance that the result is correct. This improves confidence of the research.

There were also significant improvements in the CS-PFP. RPE for the particular tasks did not increase indicating that the perceived exertion did not increase even though the group were functioning at a higher level. This suggests that participants could manage more activity without increasing pain levels, making them more functional.

There was no significant difference between the myalgic scores with tender points and FIS remaining similar from start to finish of the study and between groups.

The study supports the argument that progressive strength training can be utilized successfully to improve strength and some elements of functional ability. It does not seem to have any effect on muscular pain. The high drop-out in the strength group was unfortunate. This did not seem to be due to difficulty with exercise but does seem to be a coincidence that it did not occur within the control group.

The equipment used, Nautilus, was not only used to assess overall muscle strength but also to work out the resistance to be used and it was also part of the training equipment. This piece of equipment is not widely available in many hospital outpatient departments as it is very expensive. This may create difficulties in reproducing the exact strength programme set out in the article, and as such would make it difficult to replicate in a clinical setting.

The overall length of this study was only 12 weeks. It would have been beneficial if there was some follow up period to ascertain if gains achieved had been maintained and the intervention had a lasting effect. This is important as FM is a chronic long term condition so short term benefit may be futile if there is no lasting effect.

The research did seem to be well constructed but I feel it lacked an adequate sample size to make it a credible piece of research. Another negative feature may be use of only females. Although this is a syndrome which affects mostly women it would be useful to include men so that the sample represents the whole population of patients that one sees in a clinical setting.

Tomas-Carus et al, (2008) examined the effects of physical training in warm water. It was hypothesised that this improves the physical and mental health in women with FM.

This is a randomized control trial performed over an eight month period. Patients were recruited via advertising from a local FM association in Spain. 40 people responded to the advertisement which 38 consented to treatment. Another 5 were excluded due for not meeting the inclusion criteria. This was primarily due to the fact that they were attending other therapies at the time. Thirty three women finally undertook the research. They were randomized pair wise into 2 groups: The exercise group and a control group. Two patients in the exercise group and 1 in the control group failed to complete the research. They were omitted from the research and intention to treat was not analysed – to the detriment of the study’s validity.

Assessments were taken for baseline and at 8 months and were undertaken at the University of Estremadura, Spain by an exercise physiologist and an assistant who was blinded to condition and group assignment. Making this a single blind randomized study.

Assessments for FM impact and anxiety status were performed by undertaking a FIQ and the State-Trait Anxiety Inventory (STAI).

Physical Fitness was assessed by the Canadian Aerobic Fitness Test which can be used as an estimate of VO2 max. VO2 max is a measure of the body’s ability to transport oxygen whilst exercising – this is traditionally a measure of fitness. Hand grip strength was assessed by using a hand grip dynamometer. Various other validated physical/functional/flexibility tests were undertaken as well as one test for balance.

The exercise component consisted of participating in supervised exercise in waist high water. The exercise session lasted over 1 hour and included a 10 minute warm up , 10 minute aerobic session, 20 minutes of resistance work, further 10 minutes of aerobic and finishing10 minutes of cooling down. This was repeated 3 times a week over a period of 8 months.

Kolgormorov-Smirnov test was used to assess normality of data – this test is used to objectively analyse the data thoroughly providing greater confidence in its results. ANOVA was used to calculate differences of baseline and Exercise group and that of the control group. Significance levels were set at 0.05 levels.

Baseline data did not show any significant difference from between the groups. This implies that any difference within the groups can be accepted with greater confidence.

At the end of this study it was found that the mean values of the group which had taken part in eight months of water exercise had significantly improved the STAI scores and also the FIQ. Of particular interest were the improvements in stiffness and anxiety: 53% and 41% respectively.

There were also significant improvements in the physical fitness aspect of the study. The greatest mean score improvements were found with balance and stair climbing with a 10kg: 30% and 25% respectively. There was no significant improvement with hand grip or flexibility.

Although this study demonstrated significant changes in most of the fields examined, these were not more informative than those which were found in previous studies which did not run for as long a time Mannerkopi et al, (2000), Jentoft et al (2001), Rooks et al (2002), Altan et al (2004). This may be attributed to the fact that the study guided the participants to undertake exercise at a low and steady intensity and therefore the improvements may have been made early on. It could be due to the fact that the programme was not intense enough to push for greater improvements. These variables might have been eliminated by making an assessment mid way through the experiment, but unfortunately this was not done, and there is therefore there is no evidence to suggest a programme had to last this long.

Again there was a small sample study which only included women with a mean age of 51 years who had symptoms for a long time (mean of 20 years) with many localised tender spots (mean 17). As the study is so specific, it would be difficult to suggest that it may be beneficial to anybody outside this group of individuals.

What was impressive about the study was the relative low drop out. This may be due to the construction of the study, the dynamics of the group or the medium of exercise (water based) which encouraged people to persist with the exercise.

The difficulty with reproducing this study is the obvious difficulty in resources, we have a hydrotherapy pool available in one part of the trust but at present not in the local area. A partnership agreement would have to be discussed with local community run pools to realise a long term programme as that discussed in this research.

Rooks et al (2007) examined the effects of group exercise, education and self management in women with FM. This study divided the treatments into categories that included Aerobic and Flexibility training (AE), Strength, aerobic and flexibility Training (ST), a Fibromyalgia Self Help Course (FSHC) and finally a combination of ST and FSHC which was termed as ST-FSHC.

Three hundred and fifty-six potential participants were screened down to 207 after exclusion criteria were met. It should be noted that a third (110) declined to participate.

The randomisation process was blinded but was stratified to limit the chance of imbalance existing in the groups.

The different groups were held over 3 sites in the region of Boston.

The exercise programmes included 1 hour of exercise including warm-up, walking which was progressed from 5 minutes to 45 minutes in the AE and to 20 minutes in the ST group. The ST group included 25 minutes of strength exercises; this included 6 strength exercises which were progressed by amount and sets when the participants felt able to increase. Both programmes had a flexibility session at the end. Participants had to attend 2 classes a week and were asked to complete another session unsupervised.

The education component involved 7 sessions of self help information on various aspects of pain management. These included lectures and group work. Sessions lasted 2 hours every 2 weeks. All the instructors had achieved certificate level as ratified by the Arthritis Foundation – this limits variability between instructors and strengthens the research.

Data analysed at baseline and at the end included the FIQ for physical function and general symptoms. The SF-36 Short Form Health Survey questionnaire is a validated physical/functional assessment tool as well as an assessor of the psychological impact of health. Functional testing was achieved by the distance covered in a 6 minute walk. Secondary outcomes included The Beck Depression Inventory (BDI) questionnaire evaluates mood into separate and progressing levels of depression and the Arthritis Self-Efficacy Scale – a measurement tool to examine how effectively the individual is managing their symptoms.

The analysis of the data was performed under ITT. Shapiro-Wilk test was used to test baseline to follow up. Changes within the group were assessed primarily using a paired t-test, which can be used effectively with larger sample sizes.

A power score was calculated needing 31 participants in each group to achieve a score of 90%. Around 50 or over were put into each group as a drop out of 30% could be achieved without affecting the statistical outcome. This provides a robust side to this research as the results can more confidently be taken into ones clinical practice.

Unfortunately there were a proportion of dropouts; these were all accounted for in the study. The largest amount was in the FSHC (46%) with the main reason given that they were dissatisfied with the randomisation.

Of the remaining people in the study the mean attendance rate ranged between 73 and 78%.

There was no significant difference between baseline groups. Results showed significant difference in all the physical recordings in the exercise approaches, with or without strength element, when compared to the educational group. Secondary factor of self efficacy and BDI was greater in the exercise group when compared to the education alone. This was greater in the groups which included the FSHC which enhanced the results, but only when in conjunction with exercise based activity.

This study was well constructed but did not have a control group, making it difficult to assess the real improvements when compared to no treatment whatsoever. The exercise groups involved simple reproducible regimes which could be used in an outpatient setting. It would have been advantageous to have a 12 month follow up instead just 6 months as to reiterate FM is a chronic condition and thus long term follow up would give us better in sight to the benefits of the regime. AE had better outcomes than ST. This was not elaborated upon. Would a combination of self help and aerobic exercise only, have greater overall benefit?

Valkeinen et al. (2008) also examined the effects of concurrent strength and endurance exercise on women suffering with Fibromyalgia. They looked at the variables of aerobic capacity, muscle strength and functional tasks.

The study took part over 21 weeks and involved 26 participants who were female and post menopausal. The participants were randomized and the assessors were blinded.

The process of enrolment saw 180 invited, 71 agreeing to take part with 45 being excluded for not meeting the inclusion criteria. 15 were allocated to intervention and 11 were put into the control group.

The intervention comprised 3 sessions a week which would be split into 2 aerobic and 1 strength in week 1, and 2 strength and 1 aerobic the following week and so on. The endurance training took part on a bicycle, except when it occurred on the 2 endurance sessions in the week, and when this happened 1 session was performed unsupervised either walking or cycling at low intensity. Sessions started at 30 minutes but progressed up to 60 minutes over the course of the trial.

Strength-training took part over 60 minutes to 90 minutes. Again this was progressed through the trial.

Participants were assessed for aerobic capacity with VO2 max and strength was measured using dynamometers measuring 1 repetition maximum for lower limb, upper limb and grip strength.

Functional testing was measured by the best of 3 attempts for a timed 10 meters walk and 10 step climb. The completion of the Stanford Health Assessment Questionnaire (HAQ) was utilized as this is a capable tool to measure functional ability.

Visual analogue scales (VAS) were used to measure perceived pain, sleep quality, general well being and general fatigue.VAS are easily reproducible and understood, they are validated outcome measures and effective at measuring change.

Results were collected throughout the research in a staggered way to limit the effects of fatigue on results – this, I felt this was a competent way of ensuring realistic results in a client group where fatigue is a real issue.

There was found to be no significant difference between baseline results, and throughout the course of the research both groups had similar adherence with participation to exercise.

There was no significant difference demonstrated between groups when assessing VO2 max. Significant increases with 95% confidence levels were found when comparing control and active group on maximal muscle force in lower limb strength and also functional performance. The HAQ did not change significantly when comparing group to group.

Perceived symptoms had a positive significant change in the exercise group. This was not mirrored in the control group.

I favoured the construction and plan of this piece of research. Sample sizes started off large but sadly decreased as they went through the process of eligibility. Aerobic exercise had no effect on V02 max because the exercise was not intense enough. Also upper limb strength failed to improve enough to make a significant difference. This might be due to the fact that concurrent exercise in this manner means that you do not do enough of either, and perhaps maybe lose focus of the goals.

Wang et al, (2010) carried out a single blind, randomised trial to establish the effectiveness of Tai Chi compared to a control of wellness education and stretching exercises. It was hypothesised that at the end of 12 weeks, participants taking the route of Tai Chi intervention would have significant reduction in pain and also improves their sleep pattern and physical and psychological benefit when compared to a control. This was measured by primarily the FIQ but also had secondary data from the SF36, Global pain scores using VAS, Sleep using the Pittsburgh Sleep Quality Index (PSQI), 6 minute walk test measured in yards for physical ability, a self efficacy score the Chronic pain self efficacy scale (CPSS) and a depression score (CES-D) – These were administered at 0, 12 and 24 weeks.

Participants either took part in Tai Chi classes, which took place twice a week for 12 weeks (each session lasting 60 minutes). Each session was taught by a Tai Chi master. Participants were also instructed to practice at home the techniques learnt at home also for 20 minutes a day. They were compared to a control group of a wellness education and stretching programme. This also lasted 60 minutes and was held twice a week over 12 weeks. Wellness sessions comprised didactic teaching of a topic relating to FM and the stretching arm was done for 20 minutes at the end of the session and involved all major muscle groups with stretches held for 15 to 20 seconds. Participants were instructed to repeat the stretches every day.

This research was performed between July 2007 and December 2008. 356 participants were screened. Only participants who resided near to Boston were considered. Out of the 124 participants who resided near Boston, 90 qualified to take part (there was stringent inclusion/exclusion criteria). 24 patients were excluded after baseline assessment. 66 patients were randomized to either take part in Tai chi or wellness and stretching. A table explains the process and all participants are accounted for.

Rate of attendance was 70% for the control group and 77% for the Tai chi group. There were five withdrawals from this study by twelve weeks and this increased to seven by 24 weeks.

At twelve weeks, participants within the Tai Chi group had decreased scores in the FIQ (95% confidence levels). There was also significant differences with the SF36 with a p value of 0.001 for the physical component and p = 0.03 for the mental component scores. Improvements were maintained at 24 weeks for the between group scores on the FIQ (p=0.03), but other changes between groups were not of a significant difference.

This research has limitations. It is not a double blind study. This is discussed in the article and decided that this would be too difficult to perform for this intervention. The Tai Chi component was delivered by a single Tai Chi master and also done in one centre. This makes it quite particular to one area and limits the potential differences that may come up from site to site and with different instructors. Participants were only followed up for 24 weeks – due to this we have limited long term results for this intervention. This is a piece of research which has some positive outcomes, but a larger clinical number over a larger geographical area would allow the data to be considered in a more confident manner and more readily taken on a clinical manner.

Conclusion

This literature review has informed on the benefits of supervised group exercise on people suffering with FM.

Kingsley et al, (2005) demonstrated that a graduated twice weekly strengthening programme exhibited significant improvement in upper, lower body strength and functional ability. Unfortunately, low sample numbers combined with drop outs cast doubt on the validity of the research and its use in a clinical setting.

Rooks et al (2007) discovered that exercise which included aerobic and stretching or strength, aerobic and stretching performed 3 times a week demonstrated significant improvements in functional ability, self-efficacy and mental well being. This effect was increased when combined with educational self care component. This study also had a calculated power score so evidence from this research can transferable to clinical setting with confidence.

Tomas-Carus et al (2008) found with exercising over an eight month period in warm water 3 times a week had significant increases in reported well being, function and aerobic fitness. This did not improve on previous research of a shorter period and had a small sample size with no power score. On a positive note retention within the study was excellent and had very low incidence of drop outs. This could have an important clinical application. Exercising for people with FM tends to cause flare ups and increases in pain. It is noted that most of the research had to factor a 30% drop out rate (Rooks et al, 2007).It could be argued that the patients that experience difficulty exercising in a traditional strength/aerobic and stretching way find it easier to tolerate exercise in warm water.

Valkeinen et al, (2008) examined effects of concurrent strength and endurance exercise on women with FM. No significant difference was noted in VO2 max but had significant differences in, leg extensor strength and some functional tasks. Overall, was disappointing. The poor results were probably due to the frequency of the exercise being 1.5 sessions weekly of aerobic and strength. This potentially limited carryover. This confers that exercise needs to be appropriate and performed on a regular basis.

Wang et al (2010) examined the effects of Tai chi and found that performing it twice a week for 1 hour over 12 weeks showed significant improvements in patient reported symptoms but significant increases in functional tests at end of intervention 12weeks.

The studies can inform our clinical practice. We need to be specific to what the individual needs is it aerobic/endurance, strength, flexibility or a mind/body intervention. We need to be honest in the respect that exercise may not have significant improvements in the case of pain relief. If knowing the individuals need we can tailor group work to their want and achieve a relevant positive outcome.

REFERENCES

Altan L et al (2004) Investigation of the effects of pool based exercise on fibromyalgia syndrome. Rheumatology International; 24:272-277.

Carville SF et al (2008) EULAR evidence-based recommendations for the management of Fibromyalgia syndrome. Annals of the Rheumatic Diseases 67:536-541

Croft PR. (2002) The epidemiology of chronic widespread pain. Journal of Musculoskeletal Pain ;10:191-99.

Gran JT. (2003)The epidemiology of chronic generalized musculoskeletal pain. Best practice research in Clinical Rheumatology; 17: 611-27 Nice 2009 Low back pain Early management of persistent non-specific low back pain www.nice.org.uk

Kingsley et al (2005) The effects of a 12-week Strength-Training program on strength and functionality in women with Fibromyalgia. Archives of Medical Rehabilitation; 86: 1713-1721.

Hauser W.,Thieme K., Turk D. (2010) Guidelines on the management of

Fibromyalgia syndrome – A systematic review European Journal of Pain; 14:5-10

Jentoft ES, Kvaivick AG, Mengshoel AM. Effects of pool based and land based aerobic exercise on women with fibromyalgia/chronic widespread muscle pain. Arthritis Care Res ; 45:42-47.

Mannion AF et al (2001) Comparison of the active therapies for chronic low back pain:results of a randomized clinical trial with one-year follow-up. Rheumatology 40 (7):772-778

MannMannion AF, Müntener M, Taimela S, Dvorak J. Comparison of three active therapies for chronic low back pain: results of a randomized clinical trial with one-year follow-up. Rheumatology. 2001; 40 (7):772-778.

Mannerkopi et al (2000). Pool exercise combined with an education program for patients with fibromyalgia syndrome. A prospective, randomized study. Journal of Rheumatology ; 27:2473-2481.

Rooks DS, Silverman CB, Kantrowitz FG. (2002) The effects of progressive strength training and aerobic exercise on muscle strength and cardiovascular fitness in women with fibromyalgia: a pilot study. Arthritis and Rheumatology; 47:22-28

Petrie Medical Statistics at a glance.

Sim J. Adams N (2003) Therapeutic approaches to fibromyalgia syndrome in the United Kingdom: a survey of occupational therapists and physical therapists. 7: 173-180.

Tomas-Carus et al. (2008) Eight months of physical training in warm water improves physical and mental health in women with fibromyalgia: A Randomized control trial. Journal of Rehabilitation medicine; 40:248-252.

Valkeinen H. et al (2008) Effects of concurrent strength and endurance training on physical fitness and symptoms in postmenopausal women with Fibromyalgia : A randomized control trial; 89:1660-1666

Wolfe F, Smythe H, Yunnus MB et al. (1990)The American College of Rheumatology 1990 criteria for the classification of Fibromyalgia. Report of the multicentre criteria committee. Arthritis Rheumatology; 33: 160-215

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