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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04214925
Other study ID # 60116787-020 / 20653
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 15, 2019
Est. completion date June 28, 2019

Study information

Verified date December 2019
Source Pamukkale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

In the study, which will be planned as a randomized controlled parallel group, the effects of Tai Chi in SS patients are compared with the home exercise group. Evaluations before and after the treatment will make by a physiotherapist. Training of Tai Chi will supervised by an experienced and certified physiotherapist.

Lateral Bridge Test , Berg Balance Scale, Pittsburg Sleep Quality Index , Fatigue Severity Scale and Fatigue Impact Scale , Hospital Anxiety and Depression Scale will be used evaluation before and after training.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Tai Chi
Home exercises will include warm-up and cool-down exercises, stretching for shoulder, hamstring and erector spinae muscles, strengthening exercises for abdominal and back muscles.

Locations

Country Name City State
Turkey Pamukkale University Denizli Kinikli

Sponsors (1)

Lead Sponsor Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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

Outcome

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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