An interventional study of exercise training group and control training group in Rheumatoid Arthritis, sponsored by Gazi University. Status unknown at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-03-03.
Sponsored by Gazi University · Not applicable, Interventional, and Treatment
Rheumatoid arthritis (RA) is a chronic inflammatory disease associated with significant functional impairment and increased risk for cardiovascular and pulmonary disease. Along with pharmacological therapy, exercise seems to be a very promising intervention to improve disease-related outcomes, including functional capacity and systemic manifestations. Despite the fact that aerobic and strengthening exercises have been shown to be useful in patients with RA, there have been limited research on the effects of pilates training. Therefore, we aimed to investigate the effect of clinical pilates training on exercise capacity, respiratory and peripheral muscle strength, respiratory muscle endurance, respiratory function, pain, balance, core stability, dyspnea, functional status, fatigue, quality of life, depression and anxiety in patients with RA.
According to sample size calculation 30 patients with RA will be included. Patients will be evaluated before and after treatment. Patients will be randomized into exercise and control training groups. In the exercise training group the patients will be given pilates exercise; in the control training group, the patients will be given relaxation exercise. Pilates exercises will be applied by the physiotherapist 3 days a week for 8 weeks. The patients in the control training group will be given relaxation exercises as a home exercise program 3 days a week for 8 weeks. Exercise capacity, pulmonary functions, respiratory and peripheral muscle strength, respiratory muscle endurance, pain, balance, core stability, dyspnea, functional status, fatigue, quality of life, depression and anxiety will be evaluated.
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Exclusion Criteria:
Clinical pilates exercises
Other: exercise training group
Relaxation exercises
Other: control training group
All exercise program will be applied during supervised session by a physiotherapist. Clinical pilates exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks. The program consisted of 10 minutes warm-up exercises, clinical pilates-based exercises on mat for 40 minutes and 10 minutes relaxation and stretching exercises.
The control group will be followed up as a home program by giving the relaxation exercises. Patients will be asked to do the exercises regularly for 3 days/week, 1 sessions/day, for eight weeks. Patients in the control group will be followed up by phone once a week.
Respiratory muscle strength
Maximal inspiratory and expiratory muscle strength will be evaluated using mouth pressure device.
Time frame: First day
Respiratory muscle endurance
It will be assessed using an incremental threshold loading test, in which patients began with a load of 30% of maximum inspiratory pressure and increased by 10% every 2 minutes.
Time frame: First day
Functional exercise capacity
It will be evaluated with 6-minute walking test according to the American Thoracic Society and European Respiratory Society criteria.
Time frame: First day
Pulmonary functions contains dynamic lung volumes
Spirometry will be used to perform pulmonary function testing in accordance with the American Thoracic Society and European Respiratory Society guidelines.
Time frame: First day
Peripheral muscle strength
Upper and lower extremity muscle strength using portable hand held dynamometer, hand grip strength using grip dynamometer will be evaluated.
Time frame: Second day
Pain level
It will be assessed using with Visual Analog Scale (VAS). VAS is a scale which consists of a 100-millimetre scale ranging from 0 (no pain at all) to 100 (worst imaginable pain). A higher score indicates greater pain intensity.
Time frame: First day
Balance
The "Biodex Balance System®" will be used to test static balance. As a consequence of the test, the system will provide the general stability index, anterior/posterior (AP) stability index, medial/lateral (ML) stability index, and their standard deviations.
Time frame: Second day
Core stability
"Core" endurance and "core" power are the specific components of "core" stability and will be evaluated separately. Core muscle endurance times will assessed by using trunk extension, trunk flexion, and side bridge tests. Core power will assessed by using sit-ups ve modified push-ups tests.
Time frame: Second day
Dyspnea
The Modified Medical Research Council (MMRC) dyspnea scale will be used to determine the perception of dyspnea during activities of daily living. Dyspnea is graded as: zero (shortness of breath with strenuous exercise only); one (shortness of breath when rushing or walking up a slight uphill); two (because of shortness of breath they walk slower than people of the same age or have to stop to breathe while walking at their own pace); three (stops to breathe after walking 100 meters or after a few minutes); and four (too short of breath to leave the house or shortness of breath when getting dressed).
Time frame: First day
Functional status
Functional status will be assessed by Health Assessment Questionnaire (HAQ). HAQ consists of 20 questions, each question is scored between 0-3. A high score indicates poor functional status.
Time frame: First day
Fatigue
Fatigue will be evaluated using Turkish version of Fatigue Severity Scale. This questionnaire includes 9 items and score range for each item from 1 to 7 point (7-point Likert scale). Fatigue Severity Scale score is calculates by deriving an arithmetic mean. Cut-scores of over 4 are indicative of significant fatigue (higher scores show more severe fatigue).
Time frame: Second day
Disease Specific Quality of Life
Quality of life will be evaluated using Turkish version of the Rheumatoid Arthritis Quality of Life (RAQoL) questionnaire. This questionnaire includes 30 items, each question is scored 0 (no) or 1 (yes). A high score indicates poor quality of life.
Time frame: Second day
Anxiety and depression
Anxiety and depression will be evaluated using Turkish version of Hospital Anxiety and Depression (HAD) scale. HAD scale uses to determine the risk group of patients in terms of anxiety ad depression and consists of 14 questions. Lowest score that patients can get from both subscales is 0, the highest score 21. The cut-off points for the Turkish version of the HAD scale were 10 for the anxiety subscale (HAD-A) and 7 for the depression subscale (HAD-D).
Time frame: Second day
Plan to share: No
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Gazi University