Tai Chi Clinical Trial
Official title:
Investigation of the Effectiveness of Tai Chi Exercise Program on Trunk Endurance, Balance, Sleep, Fatigue, Anxiety and Depression in Scleroderma Patients: A Randomized Controlled Study
Verified date | December 2019 |
Source | Pamukkale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Because of multiple system involvement, patients with Scleroderma have complaints such as fatigue, sleep disturbances, functional limitations, skin deformations, pain, swollen hands and joint pain. The aim of this study is to investigate the effect of Tai Chi exercise program on trunk endurance, balance, sleep, fatigue, anxiety and depression in patients with scleroderma.
Status | Completed |
Enrollment | 28 |
Est. completion date | June 28, 2019 |
Est. primary completion date | June 20, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - have been diagnosed with scleroderma, - have been sedentary (have not routinely participated in exercise activities during the past 3 months) - have been using a fixed dose of medication for at least 6 months - no communication problems - having stable disease Exclusion Criteria: - a diagnosis of pulmonary hypertension - a history of active infection, cardiac involvement, psychiatric disorder, a history of active myositis, renal failure, metastatic cancer, pregnancy - Data of the participant whose changes were made during the study are not included in this study and participation is terminated. |
Country | Name | City | State |
---|---|---|---|
Turkey | Pamukkale University | Denizli | Kinikli |
Lead Sponsor | Collaborator |
---|---|
Pamukkale University |
Turkey,
Mitropoulos A, Gumber A, Crank H, Akil M, Klonizakis M. The effects of upper and lower limb exercise on the microvascular reactivity in limited cutaneous systemic sclerosis patients. Arthritis Res Ther. 2018 Jun 5;20(1):112. doi: 10.1186/s13075-018-1605-0. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pittsburg Sleep Quality Index | The scale has 19 items and measures 7 components of sleep quality: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction (each domain score ranges between 0 and 3). A global PSQI score corresponding to the total of the individual scores from the 7 components is calculated (range = 0-21). A result equal to 6 or above is considered indicative of poor sleep quality. The test has high diagnostic specificity for detecting clinical sleep impairment. | ten weeks | |
Primary | Fatigue Severity Scale | Fatigue Severity Scale comprises nine statements, describing the severity and impact of fatigue, with a scale of possible responses ranging from 1 ("strongly disagree") to 7 ("strongly agree"). FSS total scores are usually reported as the mean score over the nine items; a higher score indicates greater severity. | ten weeks | |
Primary | Fatigue Impact Scale | It is a scale that evaluates the effects of fatigue on daily life activities and quality of life. It contains 40 questions in total. Consists of cognitive, physical and social subdivisions. The score ranges from 0 to 160 points and the high score indicates a negative impact. | ten weeks | |
Secondary | Hospital Anxiety and Depression Scale | It is a scale that evaluates the anxiety and depression levels of individuals in 14 questions. While the answers score between 0 and 3, the high score indicates high anxiety or depression. | ten weeks |
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