Effects Of Comprehensive Inpatient Rehabilitation
Objectives: To compare the inpatient rehabilitation model (IRM), provided by physiatrist, physical therapist, rehabilitation nurse and clinical psychologist, with the home exercise model (HEM), provided by physiatrist, for rehabilitation of patients with rheumatoid arthritis (RA) and ankylosing spondylitis (AS).
Patients and Methods: One hundred-twenty eligible adult patients [60 RA (mean age 51.8±11.7) and 60 AS (mean age: 39.7±10.4)] requiring rehabilitation treatment who had not received physical therapy (PT) in the past two years were included in this study. Participants were randomly allocated into two groups IRM or HEM . The primary outcome was one of the following measures from baseline to 15 months: Disease activity score of 28 joints (DAS28) and health assessment questionnaire (HAQ) scores for patients with RA and scores of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Bath Ankylosing Spondylitis Functional Index (BASFI) for patients with AS. Outcome assessors were blinded. General estimated marginal means of multivariate comparisons were performed for both within-subject and between-subjects for statistical analyses.
Results: Mean disease duration of patients with chronic RA and AS were 8.5±6.4 (median 7) and 8.7±7.8 (median 6) years, respectively. Changes of DAS28 and HAQ scores were better in IRM group than HEM group. While most of patients with RA used combined disease-modifying antirheumatic drugs , none of the patients used anti-tumor necrosis factor agents for disease control. BASFI and BASDAI scores improvements were not different in both groups. Inpatient rheumatologic rehabilitation programs improved physical function and disease activity in patients with RA and AS. However, statistically significant changes were detected DAS28 and HAQ scores of RA patients.
Conclusion: Since patients' functioning is a central aspect of the rheumatic diseases, and remission is rare for these diagnoses, rheumatologic rehabilitation programs should be applied to all of these patients. Inpatient care was useful for patients with RA in contrast to patients with AS. It might be related to more resting period of inpatient care than usual care or ineffective drug therapy for continuing disease process in patients with AS.
Rheumatoid arthritis (RA) is chronic, inflammatory disorder affecting primarily synovium of small hands-feet joints mainly and characterized by osteodestruction to the cartilage and bone presenting with erosions. Ankylosing spondylitis (AS) is another chronic inflammatory disorder mainly affecting primarily fibrocartilage of axial skeleton and peripheral joints and characterized by both osteodestruction and following osteoproliferation such as syndesmophytes and ankylosis. Both diseases progresses and leads to chronic pain and prominent disability.(1-4)
The treatments of RA and AS should be multi-disciplinary including pharmacologic and non-pharmacologic interventions. Rheumatoid arthritis should be considered now as ‘immunologic emergency' in which early and aggressive disease modifying anti-rheumatic drugs (DMARDs) intervention is considered for suppression of disease activity and preservation of articular structure and in turn function.(1) In contrary, NSAIDs and tumor necrosis factor (TNF)-blockers are the only effective drugs for the therapy of AS because the traditional DMARDs are not effective, especially for axial disease. Despite these effective pharmacologic treatments, the most of the patients have not achieved remission at follow-up. In those patients whose disease activity is not fully controlled, RA and AS can have a significant impact on their physical, emotional and social functioning. Therefore, rehabilitation treatment, such as physical therapy (PT), occupational therapy (OT), and exercises, has played an adjunctive role to the pharmacologic management of RA and AS. Rheumatologic rehabilitation aims to prevent physical impairment and restore functional ability through the use of education, exercise, aids for daily living and mobility, and physical modalities.(3,4)
Despite widespread positive clinical experience with rehabilitative interventions, the scientific evidence of their effectiveness is, in general, scanty, owing to a lack of studies with sufficient methodological quality. There are various data about the impact of different parts of rehabilitation in RA(2-18) and AS.(18-31) These parts consisted of education,(8,17) manual therapy,(27) exercises,(5,6,12-15,22,25,26,28) PT,(3,16,19) OT,(9,20,24) and whole rehabilitation approaches(7,10,11,23) used in studies. Actually, the whole rheumatologic rehabilitation program including combination of education, exercises, PT and OT are used as patient-tailored style in clinical rheumatology practice despite limited number of this kind of studies. Also, the variable quality of the reporting clinical trials before the CONSORT statement(32) for standardization of the reporting of clinical trials was published also contributes potential bias in addition to unavoidable publication bias associated with clinical trials, where trials with positive results are more frequently published than negative studies.
The aim of this randomized controlled study was to evaluate the long-term effects of inpatient rehabilitation using composite disease activity measures and functional instruments in patients with RA and AS. For this purpose, we compared the inpatient rehabilitation model (IRM) with the home exercise model (HEM) for treating patients with RA and AS.
MATERIALS AND METHODS
Setting of the trial was tertiary rheumatologic care center treating large numbers of patients with inflammatory rheumatic diseases, regularly follow-up 785 charts annually.
Eligibility criteria for participants (i) were aged 21-75 years, (ii) had RA or AS for at least one year, (iii) presented no major variations in drug therapy in the past six months before the trial, (iv) did not present severe disability that seriously compromised independence in activities of daily living and mobility.
The exclusion criteria were (i) previous participation in rehabilitation in the past two years, (ii) major variations in drug therapy at any time during the trial, (iii) orthopedic surgery during the trial, (iv) the usage of anti-TNF drug, (v) the usage of >15 mg prednisone daily, (vi) complete ankylosis of the spine for patients with AS, (vii) severe disabling rheumatoid hand deformities.
Institutional Review Board of Ankara Training and Research Hospital approved the study protocol.
At final analysis 120 patients (66 females and 54 males mean age ??±?? years) included to per-protocol statistics (approximately 30 patients in each group). First group of participants was patients with RA according to the 1987 American College of Rheumatology (ACR) criteria.(33) The second group of participants was patients with AS according to the modified New York criteria.(34)
All patients received same 10-minutes instructions separately at their baseline and five-visit reminder of three-months interval checks for 15 months at follow-up.
1-Inpatient Rehabilitation Model : Sixty participants carried out 15-sessions physical therapy and rehabilitation program consisting of one-daily session by a four physical therapist with experiences in RA and AS and they were treated as hands-on, one-by-one manner.
The description of physical therapy by world confederation for physical therapy (wcpt.org) is implemented and modified in order to reach agreed goals and may include manual handling; movement enhancement; physical, electro-therapeutic and mechanical agents; functional training; provision of assistive technologies; patient related instruction and counseling; documentation and co-ordination, and communication. Because of involved peripheral and axial joints, possible cardiopulmonary co-morbidities and different disease activity state of each patient drug, physiatrist in Turkey has performed physical therapy and exercise prescription for rheumatic patients. Physical therapist is responsible for application of prescribed physical therapy and exercise program medicolegally.
Therefore each session of daily physical therapy and rehabilitation program provided by physical therapist in this study. There were limited number and scanty number of systematic reviews for physical therapy of RA and AS, respectively.(2-4,19) High quality evidence for joint protection and patient education, intermediate quality of evidence for aerobic activities, dynamic strengthening and low-quality evidence for conventional physiotherapy [paraffin wax bath, ultrasound, and transcutaneous nerve stimulator (TENS) for hands], comprehensive occupational therapy and exercises were reported in an overview of systematic reviews, Ottawa Panel and a clinical practice guideline for the non-pharmacologic treatments of RA.(2-4) But there were no therapeutic ultrasound and TENS studies for rheumatoid knees despite common use.
Similarly, no study was found about hot pack, faradic current and ultrasound for spondylotic spine in scientific Anglo-Saxon literature for evidence-based analysis.
I.Physical therapy modalities
- Superficial heat: paraffin bath of rheumatoid hands and hot packs of spondylotic spine for 10 minutes,
- Deep heat: ultrasound (0.5 watt/cm2/6mins) of rheumatoid knees and paravertebral spondylotic spine after the hot pack applications for 10 minutes,
- Electrotherapy: conventional TENS for rheumatoid knees and pulley faradic current for spondylotic paravertebral muscles for 10 minutes,
- Joint protection, energy conservation, pacing for patients with RA
- Activities of daily living training, joint protection (avoiding same position for a long-term, reducing the stress loading spine, control of sitting and head position), posture and positioning advice, energy conservation (regular resting, pace) for patients with AS
III.Exercises for patients with RA(8)
- Shoulder and back: active range of motion (AROM), rotation, mobilization
- Elbow: rotation
- Wrist, finger: AROM
- Hip: hip hitches, abductor strengthening, rotation
- Knee: isometric quadriceps strengthening
- Ankle: mobilization
IV. Exercises for patients with AS(31)
- Shoulder and hip range of motion (ROM)
- Neck stretching and mobilization
- Trunk rotation
- Side bending
- Cat stretching
- Lower extremity stretching
Active range of motion exercises and isometric quadriceps strengthening were repeated as 20 times in two sets daily. Mirror reflected posture training and posture exercises were instructed. Respiratory (deep breathing, diaphragmatic breathing, air-shifting and pursued lip breathing for 15 minutes) and individualized walking endurance exercises were performed three times weekly. After three-weeks of IRM patients were discharged.
2-Home Exercise Model : The sixty patients were instructed to perform the above exercises. The patients encouraged to perform them at home as two sets daily, with 20 repetitions per set, for three weeks. Respiratory and endurance exercises were also prescribed to the patients. There was no possibility for the HEM patients to ask questions to the PT or OT during the trial period. Verbal checks of adherence to the therapy by patients were used for three months reminder intervals for 15 months (total 5 visits).
Both groups received education and disease information including joint protection strategies, energy conservation/fatigue management, sleep hygiene training, and management of flare, pain relief strategies, relaxation training, exercise and physical activity recommendations.
Outcome measures of AS group included changes in activity and functional capacity, evaluated by assessor-blinded to the intervention using validated scores from the two Bath indices for AS.(35,36) Similarly, outcome measures of RA group were disease activity score-28 (DAS28) and Stanford health assessment questionnaire (HAQ).(37,38)
Primary outcomes were the Stanford HAQ for patients with RA and Bath ankylosing spondylitis functional index (BASFI) for patients with AS in this study. Secondary outcomes were composite variables including DAS28 for patients with RA and Bath ankylosing spondylitis disease activity index (BASDAI) for patients with AS.
Health status measure used to cover “functioning”, the HAQ, is an ordinal score measure (range 0-3) to gauge difficulty in performing everyday activities during the previous week(38) and a 20-item self-administered scale consisting of eight subscales (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and “usual activities”). Each category contains at least two specific components. The BASFI, “functioning” measure of AS, is a mean of the set of 10 questions designed to determine the degree of functional limitation (range 0-10) in patients with AS.(36)
Composite disease activity measures such as DAS28 and BASDAI were used in this study. Disease activity score 28 is an index including 28-swollen joint counts (28-SJC) and 28-tender joint counts (28-TJC) in addition to patient global assessments of disease activity on a visual analog scale (VAS) and erythrocyte sedimentation rate (ESR). Predefined cut-off values for remission, low and moderate disease activity are 2.6, 3.2 and 5.1, respectively(39) Bath ankylosing spondylitis disease activity index is another index including six-question patient-survey utilizing a VAS to assess fatigue, axial and peripheral joint pain, tenderness, and severity and duration of morning stiffness.(35) The sum of first four questions plus the mean of morning stiffness questions were divided five for calculation of BASDAI.
Assessment intervals were three months for disease activity indices and 15 months for functional indices. Same time indices were statistically analyzed at baseline and final 15-months. It was calculated that the number of patients included (22 in the intervention group and 21 in the control group) was the number necessary to detect a difference of >0.6 U, with an alpha (α) risk of 0.05 and a beta (β) risk of 0.30.
Randomly allocated patients were included to the study. Patients fulfilled inclusion criteria were randomly selected for the IRM and HEM groups by two attending physiatrists. Another two physiatrists prescribed standardized PT, OT, and exercises programs for RA and AS patients according to the groups. Each patient managed by one of the four female experienced physical therapists who was on call when the patient was seen in examination room. By design, each therapist treats approximately 30 participants during the two years of recruitment.
Statistical Package for Social Sciences (SPSS) 15.0 software (SPSS Inc., Chicago, Illinois, USA) were used for statistical analysis. Descriptive data were compared at the baseline for homogeneity in each patient group. Continuous data (e.g. DAS28, HAQ) were entered as means and standard deviations. One-way statistics descriptive homogeneity of variances, NPar tests of Mann-Whitney ranks and two-sample Kolmogorov Smirnov frequencies were used for drug characteristics. T-test paired sample statistics and correlations for outcomes were performed.
Multivariate tests of general linear model were applied for within-subjects and between-subjects effects. In general linear model analysis HAQ, DAS28, BASFI and BASDAI scores of baseline and follow-up were dependent variables of within subject factors. Inpatient rehabilitation was a between subject factor in this model. Tests the null hypothesis that the observed covariance matrices of the dependent variables are equal across groups were designed for HAQ, DAS28, BASFI and BASDAI. Bonferroni adjustments for multiple comparisons were based on estimated marginal means for pair wise comparisons of outcomes.
Similar baseline demographic and disease characteristics were also used to avoid selection bias. However, we couldn't provide blinding of patients and care providers because of rehabilitation nature of this study (performance bias may occur). Intention-to-treat analysis at follow-up was used to avoid attrition bias. All patients received intervention. Outcome assessors and data analysts were blinded to prevent detection bias. Effect size (0.2: small, 0.5: medium, 0.8: large) was calculated for statistically significant changing outcomes as below formula (1):
Effect size = (Δtreatment- Δcontrols) / pooled SD
Pooled SD=√ [(nt-1)x SDt2 + (nc-1)x SDc2 ] / (nt + nc)
Flow diagram of this study with pool of potential patients that all registered/randomized was shown in figure 1. Online recorded pre-planned study population was 115 patients with RA and 96 patients with AS.
Of the 60 enrolled patients with RA (51 females, 9 males; mean age 51.8±11.7 years; range 27 to 75 years; median age: 54 years, and disease duration was 8.5±7.9, median 7 years), 39 (65%) were on combined DMARDs and 21 (35%) were on mono-DMARD therapy. Test of homogeneity of variances for Levene statistic showed homogeneity for age, disease duration, and baseline DAS28 and HAQ scores.
Of the 60 patients included with AS (16 females, 44 males; mean age 39.7±10.4 years, median age 39 years, and disease duration was 8.7±7.8, median 6 years), five (8.3%) were on combined DMARDs and all patients on NSAIDs therapy. Test of homogeneity of variances for Levene statistic showed homogeneity for age, disease duration, and baseline BASDAI and BASFI scores. Baseline comparisons of statistical descriptive for IRM and HEM groups with RA and AS were similar except HAQ and BASFI and shown in table 1.
Losses including dropout, surgery, drug changes and severe disability for each group were also shown in figure 1. No significant adverse events were observed in both groups. There were not any additional DMARDs to the previous pharmacotherapy. None of the patients used anti-TNF drugs. Maximum dose of methotrexate was 25 mg weekly and maximum dose of prednisone was 15 mg daily in this study. All patients were taking NSAIDs, as individual needed dose manner.
Changes in the outcome measures
When adjusting for significant differences at baseline between the two groups, there were significantly larger improvements in the HAQ and DAS28 scores of RA patients among the patients in the inpatients rehabilitation group as compared to home exercise group.
Stanford health assessment questionnaire and DAS28 for RA and BASFI and BASDAI for AS were dependent variables of within-subjects factors in general linear model analysis. After the Bonferroni adjustment of multiple comparisons, multivariate test results were shown in table 2. Both improvement of DAS28 (p=0.001) and HAQ scores (p=0.001) were better in IRM group than HEM group (p=0.001). In contrary, changes in BASDAI (p=0.07) and BASFI (p=0.08) were similar in both IRM and HEM groups.
Calculated effect sizes of IRM were 0.2 (small) for DAS28 and 0.6 (medium) for HAQ.
We found that compared to home exercise, comprehensive inpatient rehabilitation was effective on function and disease activity in patients with RA, but had no effect in AS. This situation might be related to difference in pharmacologic treatments. The most of our patients with RA were on combined DMARDs therapy, but none of the patients with AS on anti-TNF therapy in our sample. Patients were at regular follow-up with three-months intervals for 12 months. Functional measures were repeated yearly; therefore same-time baseline and 12-month results were analyzed.
In our study, both rehabilitation and home exercise groups received education and disease information including joint protection strategies, energy conservation/fatigue management, sleep hygiene training, and management of flare, pain relief strategies, relaxation training, assistive devices, home exercise program and physical activity recommendations (defined as moderately intensive activity, most days of the week) in addition to participation in physical activity in everyday life.(18) Rehabilitation group received also physical therapy modalities (thermotherapy, electrotherapy).
Rehabilitation studies can be both comprehensive and the single application of common rehabilitative treatment modalities. Because of additive effects of different modalities and single modality not used in the real-practice, we applied comprehensive multidisciplinary team care program routinely. Such programs are aimed at improving disease activity, physical and psychosocial functioning, with the ultimate goal of assisting patients to achieve and maintain maximal personal independence. More disabled cases needed inpatient rehabilitation. Therefore baseline comparisons for function (HAQ and BASFI) showed more mean scores of inpatient group.
The complementary role of rehabilitation, are supported by number of systematic reviews and umbrella reviews for the management of RA (3,10,13,16,18) and AS (18,19,21,31,40). International guidelines, including the ones developed by ACR guidelines on RA,(1) and the Assessment of SpondyloArthritis international Society ASAS / European League Against Rheumatism (EULAR) recommendations on AS(41) also endorse the use of non-pharmacological interventions as an adjunct.
These guidelines originated from evidence based medicine and there were some differences and similarities between RA and AS.(18).
While aerobic activities, dynamic strengthening, and patient-education concerned intermediate evidence level, use of splints/assistive devices, balneotherapy/spa therapy, and conventional physiotherapy had low evidence level in RA.(2) The Ottawa Panel also recommends the use of physical therapy (low-level laser therapy, therapeutic ultrasound, thermotherapy, electrical stimulation, and TENS for the management of RA.(4) After this panel high-quality evidence was reported for beneficial effects of joint protection and patient education, moderate-quality evidence for beneficial effects of low-level laser therapy and low-quality evidence for thermotherapy, ultrasound, electrotherapy, acupuncture, balneotherapy, splints, diet and exercises in an overview of systematic reviews.(3) We used most of these modalities as combined physical therapy and rehabilitation approach. Dynamic exercises are cornerstone of the non-pharmacologic treatment in this study. Electro-physical modalities, involving the use of thermal, electrical, and sound energy, have been used to generate therapeutic physiological effects with the aim to reduce pain or prepare exercises or restore function in rehabilitation practice. Unfortunately, there is no universal model of rehabilitation for patients with RA. The Finnish statutory inpatient rehabilitation system, as an example, had no positive impact on either functional (HAQ) or work capacity during the first few years for patients with recent-onset RA in the Finnish rheumatoid arthritis combination (Fin-RACo) trial for five-years follow-up.(7) Baseline socio-economic demographics were different in this long-term retrospective trial. In contrary, our patients with chronic RA showed similar characteristics with significant improvement in function and disease activity at 15-months follow-up.
Compared to RA, there are relatively few controlled non-pharmacological intervention studies in AS. A Cochrane review showed that supervised group physiotherapy had moderate quality of evidence; home exercise had low quality of evidence on mobility and physical function in AS (19). In small controlled studies, it was found that group physiotherapy (inpatient) was not better than home exercise in pain,(42,43) morning stiffness,(43) BASFI,(43) and spinal mobility,(42,43) except modified Schoeber test(43) in small controlled studies for three week inpatient hydrotherapy + exercise(46) and six-week inpatient exercise(42) interventions at six months follow-up of small samples. Disease activity was not evaluated in these studies. Similarly, we couldn't find any difference of BASFI and BASDAI between inpatient rehabilitation and home exercise in our sample. It might be depends on pharmacologic treatments has no effect on disease process of AS. None of our patients used anti-TNF drugs in this study. Lubrano et al.(30) found that an intensive rehabilitation program combined with etanercept was significantly better than rehabilitation alone in terms of BASFI, the revised Leeds disability questionnaire, spinal mobility and 6-min walking test. Elyan and Khan(31) recommended instructions on proper posture training and home exercise of stretching, spinal extension, and deep breathing exercises twice daily for every patients with AS and encouraged to perform water exercises if they can. They also recommended formal physical therapy, and in most severe cases, inpatient rehabilitation may be of benefit to select patients with AS. In addition, patients at risk for cardiovascular disease should be carefully evaluated to determine the safety of an exercise program.
In comparison with regular outpatients care, inpatient comprehensive multidisciplinary team care programs were more effective, but slightly more expensive.(44) However, we don't have cost of care studies about inpatient care compared to home exercise in Turkey. From the literature we know that inpatient care is expensive and therefore the home exercises could be favorable, but not enough for some patients. Currently, inpatient care is reserved for patients who have the most advanced rheumatic disease with the most functional impairment. The illness must be sufficiently severe to require daily monitoring by physician and health professionals. Actually, inpatient rehabilitation is not defined by the diagnostic related groups (DRG) system in developed countries but has also responded to the trend of reduced inpatient days.(45) Medicare requires that patients with rheumatic disease have reductions in activities of daily living and mobility that have not responded to outpatient treatment.
Patients' functioning is a central aspect of the rheumatic disease according to the International Classification of Functioning, Disability and Health (ICF) core sets for RA and AS.(46) We found that our inpatient rehabilitation model is useful for patients' functioning in patients with RA on DMARDs therapy. However, inpatient rehabilitation had no impact on function in patients with AS using NSAIDs therapy. Inpatient rehabilitation programs should be recommended to disabled patients with RA on effective pharmacologic therapy. Because little is known on the optimal model(s) for providing rehabilitative care for patients with RA and AS more research will be needed to guide clinicians' decisions in using both inpatient and outpatient rheumatologic rehabilitation programs. Further well-designed clinical studies are warranted with respect to several rehabilitation interventions where evidence is falling short.
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