Clinical trial NCT03836820: Effects of Clinical Pilates Exercises in Patients With Rheumatoid Arthritis
Official title: Effects of Clinical Pilates Exercises in Patients With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arhritis
Pilates exercises
Fatigue
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2019-02-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Rheumatoid arthritis (RA) is a chronic inflammatory disease characterised by polyarthritis and erosive synovitis. Articular and extraarticular sympthoms are mostly seen in patients with RA. Additionally, extra complaints such as depression, fatigue, kinesiophobia and physical inactivity may accompany. Positive effects of physical activity and exercise are known. In some studies, effects of pilates exercises have been investigated on many different diseases such as Multiple Sclerosis, Ankylosing Spondylitis and breast cancer. The aim of this study is to investigate effects of clinical pilates exercises on fatigue, depression, aerobic capacity, pain, quality of life, disease activity and sleep quality.

Detailed description: Rheumatoid arthritis (RA) is a chronic inflammatory disease characterised by polyarthritis and erosive synovitis and is associated with progressive impairments and activity limitations. It may cause destruction of bone and cartilage by affecting synovial joints symmetrically. Organ involvement may be seen in the patients with RA as well as joint involvement. Initiation of the disease is mostly insidious and varies from patient to patient. Hand, wrist, foot, elbow and knee joints involvement are common. Furthermore almost all joints may be affected. Extraarticular symptoms are subcutaneous nodules, visceral nodules, cardiologic involvement, pulmonary involvement, eye involvement, neurological involvement, vasculitis, felty syndrome, amyloidosis, osteoporosis, liver and renal involvements. These symptoms may cause some extra complaints such as depression, fatigue, kinesiophobia and physical inactivity. Studies in literature have reported reduction in physical activity level in patients with RA. Reasons of physical inactivity can be listed as general obstacles such as lack of time, lack of motivation, weather condition and disease related blocks such as pain, fatigue, disease activity, depression, kinesiophobia. Depression prevalence in RA patients is found between 14.8% and 38.8% and this rate is estimated five times more than healthy people. Also, a study investigating pain in RA patients resulted that pain may be correlated with fatigue and depression. Fatigue which is frequently observed complaint of patients with rheumatic diseases is reported incidence between 40% and 80%. RA patients have been reported at high risk for cardiovascular diseases in EULAR recommendations.

Positive effects of physical activity and exercise on physiological, morphological and psychosocial conditions are known. Endurance, flexibility, muscle strength, body composition, self confidence and mood improve by regular exercise and high physical activity level. Furthermore, anti-inflammatory affects of exercise are proved in last years. Aims of pilates exercises which are developed by Joseph Pilates are to increase motor control, range of motion, flexibility, muscle strength and endurance, to improve balance, respiratory pattern and body awareness, to reduce stress. There are many studies investigating affects of pilates exercises on quality of life, functional capacity, posture, pain for different diseases including Multiple Sclerosis, Ankylosing Spondylitis, breast cancer. Aerobic and strengthening exercises reported to have positive affects on fatigue, quality of life, depression and pain for RA patients. The aim of this study is to investigate effects of clinical pilates exercises on fatigue, depression, aerobic capacity, pain, quality of life, disease activity and sleep quality.

Eligibility criteria: Inclusion Criteria:

* Patients between the ages of 18 to 65 and who have diagnosed with RA according to American College of Rheumatology criteria will be included the study.

Exclusion Criteria:

* Patients who were pregnant, diagnosed with malignancy, had changes of medical treatment in the last 3 months, had dysfunction that limited physical activity such as severe neurological impairment, immobility or cooperation deficits, had regular exercise habit (minimally three days in a week), had high disease activity score (DAS-28\>3.2) and had cardiac symphtoms according to New YorkHeart Association will be excluded from the study.

Primary outcomes:
measure: Aerobic capacity
timeFrame: 6 minutes
measure: Fatigue severity scale
timeFrame: 2 minutes
Secondary outcomes:
measure: Beck Depression Inventory
timeFrame: 2 minutes
measure: Short Form McGill Pain Questionnaire
timeFrame: 1 minute
measure: Pittsburgh Sleep Quality
timeFrame: 2 minutes
measure: Disease Activity Score- 28
timeFrame: 10 minutes
measure: The Rheumatoid Arthritis Quality of Life Questionnaire
timeFrame: 2 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
affiliation: Gazi University Faculty of Health Sciences
name: Deran Oskay
role: STUDY_DIRECTOR
References:
citation: Munsterman T, Takken T, Wittink H. Are persons with rheumatoid arthritis deconditioned? A review of physical activity and aerobic capacity. BMC Musculoskelet Disord. 2012 Oct 18;13:202. doi: 10.1186/1471-2474-13-202.
citation: Rongen-van Dartel SA, Repping-Wuts H, Flendrie M, Bleijenberg G, Metsios GS, van den Hout WB, van den Ende CH, Neuberger G, Reid A, van Riel PL, Fransen J. Effect of Aerobic Exercise Training on Fatigue in Rheumatoid Arthritis: A Meta-Analysis. Arthritis Care Res (Hoboken). 2015 Aug;67(8):1054-62. doi: 10.1002/acr.22561.
citation: Yentur SB, Atas N, Ozturk MA, Oskay D. Comparison of the effectiveness of pilates exercises, aerobic exercises, and pilates with aerobic exercises in patients with rheumatoid arthritis. Ir J Med Sci. 2021 Aug;190(3):1027-1034. doi: 10.1007/s11845-020-02412-2. Epub 2020 Oct 22.