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Effectiveness of Tai Chi Exercise Program in Scleroderma Patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04214925
Enrollment
28
Registered
2020-01-02
Start date
2019-04-15
Completion date
2019-06-28
Last updated
2020-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tai Chi

Keywords

Scleroderma, Tai Chi, sleep, fatique, depression, anxiety

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.

Interventions

OTHERTai 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.

Sponsors

Pamukkale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

randomized controlled parallel group

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Pittsburg Sleep Quality Indexten weeksThe 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 Scaleten weeksFatigue 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.
Fatigue Impact Scaleten weeksIt 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.

Secondary

MeasureTime frameDescription
Hospital Anxiety and Depression Scaleten weeksIt 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026