search
Back to results

Effectiveness of Tai Chi Exercise Program in Scleroderma Patients

Primary Purpose

Tai Chi

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Tai Chi
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tai Chi focused on measuring Scleroderma, Tai Chi, sleep, fatique, depression, anxiety

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pamukkale University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Group of Tai Chi intervention

Group of home exercises

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 25, 2019
Last Updated
December 30, 2019
Sponsor
Pamukkale University
search

1. Study Identification

Unique Protocol Identification Number
NCT04214925
Brief Title
Effectiveness of Tai Chi Exercise Program in Scleroderma Patients
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
April 15, 2019 (Actual)
Primary Completion Date
June 20, 2019 (Actual)
Study Completion Date
June 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tai Chi
Keywords
Scleroderma, Tai Chi, sleep, fatique, depression, anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled parallel group
Masking
Participant
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group of Tai Chi intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Group of home exercises
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Tai Chi
Other Intervention Name(s)
Home exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pittsburg Sleep Quality Index
Description
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.
Time Frame
ten weeks
Title
Fatigue Severity Scale
Description
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.
Time Frame
ten weeks
Title
Fatigue Impact Scale
Description
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.
Time Frame
ten weeks
Secondary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale
Description
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.
Time Frame
ten weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayse Ayan, Dr
Organizational Affiliation
Antalya Education and Research Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Pamukkale University
City
Denizli
State/Province
Kinikli
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data are analyzed with SPSS (22.0 version) package program. Descriptive statistics will be presented as mean ± standard deviation (SD), number (n), and percentage (%).
Citations:
PubMed Identifier
29871697
Citation
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.
Results Reference
background

Learn more about this trial

Effectiveness of Tai Chi Exercise Program in Scleroderma Patients

We'll reach out to this number within 24 hrs