Rheumatoid Arthritis Clinical Trial
Official title:
Effects of Clinical Pilates Exercises in Patients With Rheumatoid Arthritis
NCT number | NCT03836820 |
Other study ID # | 436 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | December 24, 2018 |
Est. completion date | October 2019 |
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | October 2019 |
Est. primary completion date | July 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Gazi University | Ankara |
Lead Sponsor | Collaborator |
---|---|
Gazi University |
Turkey,
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. Review. — View 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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Aerobic capacity | The 6-minute walk test is a submaximal exercise test used to quantify the functional exercise capacity in clinical populations. It measures the distance walked within a period of 6-minutes. | 6 minutes | |
Primary | Fatigue severity scale | Fatigue is a normal response to physical exertion or stress but can also be a sign of a physical disorder. In the common sense, fatigue is a condition known to everyone from his or her own experience,irrespective of his or her age, gender, or health. Fatigue severity scale consists of nine questions; each question is scored from 1 to 7 | 2 minutes | |
Secondary | Beck Depression Inventory | The Beck Depression Inventory (BDI) is world-wide among the most used selfrating scales for measuring depression. BDI consists of 21 items related to depressive symptoms such as pessimism, sense of failure, guilt, dissatisfaction, sleep, appetite and fatigue. Each item is scored between 0 and 3. Total score is 63, and an increase of the score means increased severity of depression. According to this scale 1-10 points are defined as normal, scores between 11-16 indicate mild mental distress, 17-20 indicate the patient is at the border points for clinical depression, 21-30 indicate moderate depression, severe depression scores are between 31-40 and 40 points above are interpreted as a very serious depression. | 2 minutes | |
Secondary | Short Form McGill Pain Questionnaire | This questionnaire consists of 11 sensory and 4 affective descriptive words. These 15 words are described as 0 = absent, 1 = mild, 2 = moderate, 3 = severe pain. So three type of pain scores (sensory, affective, total = sensory + affective) are obtained. In McGill Pain Questionnaire, the current level of pain is measured by Visual Analog Scale (VAS) and Likert scale consisting of 6 points (0 = no pain, 1 = mild, 2 = irritating, 3 = bothersome, 4 = terrible, 5 = unbearable). | 1 minute | |
Secondary | Pittsburgh Sleep Quality | The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. | 2 minutes | |
Secondary | Disease Activity Score- 28 | Disease Activity Score (DAS) is an assessment tool used to measure the level of disease activity in patients with RA. The DAS combines information from swollen joints, tender joints, erythrocyte sedimentation rate (ESR), and patient self-report of general health | 10 minutes | |
Secondary | The Rheumatoid Arthritis Quality of Life Questionnaire | The Rheumatoid Arthritis Quality of Life (RAQoL) questionnaire is a disease-specific quality of life measure that was developed simultaneously in the UK and the Netherlands. The content of the RAQoL was derived from in-depth qualitative interviews with RA patients exploring. the impact of RA on their QoL. |
2 minutes |
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