Effectiveness of Tai Chi Exercise Program in Scleroderma Patients

NCT ID: NCT04214925

Last Updated: 2020-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-15
• Study Completion Date: 2019-06-28

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.

Conditions

Tai Chi

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group of Tai Chi intervention

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.

Group Type: EXPERIMENTAL

Tai Chi

Intervention Type: 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.

Group of home exercises

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.

Group Type: OTHER

Tai Chi

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Home exercises

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pamukkale University

OTHER

Sponsor Role: lead

Responsible Party

Bilge Basakci Calik

Assoc Prof, PT

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ayse Ayan, Dr

Role: STUDY_DIRECTOR

Antalya Training and Research Hospital

Locations

Pamukkale University

Denizli, Kinikli, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 29871697 (View on PubMed)

Other Identifiers

60116787-020 / 20653

Identifier Type: -

Identifier Source: org_study_id