Effectiveness of Tai Chi Exercise Program in Scleroderma Patients

NCT04214925 | Completed

• 1 other identifier: 60116787-020 / 20653
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Tai Chi

Keywords

Scleroderma; Tai Chi; sleep; fatique; depression; anxiety

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Hospital Anxiety and Depression Scale

  ten weeks

Study Arms (2)

Group of Tai Chi intervention

EXPERIMENTAL

Tai Chi exercise program will create by selecting the first-basic 10 forms from 24 short forms of Yang style. The forms' name: Beginning, Parting the Horse's Mane, Stork Spreading Its Wings, Brushing Your Knees and Stepping, Playing The Pipes, Fending Off the Monkey, Grasping the Sparrow's Tail Left, Grasping the Sparrow's Tail Right, Simple Whip, Moving Hands Like Clouds-Conclusion. All forms will be completed at 10 weeks. Each session will take 1 hour (15 min for warming up exercises, 30 min of Tai Chi forms, and 15 min for cooling down exercises). The 14 patients of SS in this group will be divided into two groups of 7.

Other: Tai Chi

Group of home exercises

OTHER

The home exercise group will receive a one-hour home program, 2 days a week. The first and last 15 minutes of the exercise program will consist of warm-up and cooling- down exercises. After warm-up exercises, stretching for shoulder, hamstring and erector spinae muscles, strengthening exercises for abdominal and back muscles will be performed 10 times each for 30 minutes.

Other: Tai Chi

Interventions

Tai Chi OTHER

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.

Also known as: Home exercises

Group of Tai Chi intervention; Group of home exercises

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University

Denizli, Kinikli, Turkey (Türkiye)

Location

Related 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.

  PMID: 29871697 BACKGROUND

MeSH Terms

Conditions

Scleroderma, Diffuse; Depression; Anxiety Disorders

Interventions

Tai Ji

Condition Hierarchy (Ancestors)

Scleroderma, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Ayse Ayan, Dr

  Antalya Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof, PT

Model Details: randomized controlled parallel group

Study Record Dates

• First Submitted: December 25, 2019
• First Posted: January 2, 2020
• Study Start: April 15, 2019
• Primary Completion: June 20, 2019
• Study Completion: June 28, 2019
• Last Updated: January 2, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)