Effectiveness of Tai Chi Exercise Program in Scleroderma Patients

Not Applicable

Completed

• Conditions: Tai Chi

• Registration Number: NCT04214925
• Lead Sponsor: Pamukkale University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2019-04-15
• Primary Completion: 2019-06-20
• Study Completion: 2019-06-28
• Status Verified: 2019-12
• Study First Submitted: 2019-12-25
• Study First Submitted QC: 2019-12-30
• Last Update Submitted: 2019-12-30
• Study First Posted: 2020-01-02
• Last Update Posted: 2020-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fatigue Impact Scale	ten weeks	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.
Pittsburg Sleep Quality Index	ten weeks	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.
Fatigue Severity Scale	ten weeks	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.

Secondary Outcome Measures

Name	Time	Method
Hospital Anxiety and Depression Scale	ten weeks	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.

Trial Locations

Locations (1)

Pamukkale University; 🇹🇷 Denizli, Kinikli, Turkey