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Effects of a Supervised Exercise Program and a Home Exercise Program in Patients With Systemic Sclerosis

Primary Purpose

Systemic Sclerosis, Home Exercise, Aerobic Exercise

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
supervised Exercise training
home exercise trainig
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Sclerosis

Eligibility Criteria

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

Inclusion Criteria:

  • Stable clinical status for at least two weeks
  • Walking independently
  • Volunteer for research study

Exclusion Criteria:

  • Having unstable angina
  • Having uncontrolled hypertension
  • Having hemodynamic instability
  • Participating in any exercise program in the last six months
  • Having a major orthopedic or neurological problem that limits functionality

Sites / Locations

  • Dokuz Eylül Üniversitesi School of Physical Therapy and Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Supervised Exercise Group

Home Exercise Group

Arm Description

Exercise programs including warm-up, loading, cooling, and relaxation exercises are shown. The warm-up period is consist of light-paced walking, active movements of several large muscle groups. In this loading program; respiratory control training, breathing exercises, posture exercises with respiratory control , walking on the treadmill for 20 minutes without inclination , pedaling in the bicycle ergometer for 10 minutes is taken. Stretching exercises are done during the cooling period. This group was included in an exercise program 2 days a week, 45-90 minutes, for 12 weeks, accompanied by a specialist physiotherapist to the pulmonary rehabilitation unit in the chest diseases ward.

For patients to do at home (respiratory control training, shrunken lip breathing exhaustion, diaphragmatic, thoracic expansion exercises, posture exercises with respiratory control (pectoral stretching, four-way trunk exercises, head and neck exercises, bilateral shoulder flexion and abduction exercises), sitting and standing exhaustion, and brisk walking to reach 60-85% of the person's maximum heart rate.)), exercises is taught. Patients were asked to do the exercises at home for 45-90 minutes, 2 days a week, for 12 weeks. Participants of the control group are contacted every two weeks via communication methods such as e-mail, message and telephone conversation.Exercise diary is given to all patients and is taken from them at the end of the study.

Outcomes

Primary Outcome Measures

Change in Forced Vital Capacity
Pulmonary function test was applied by Sensor Medics Vmax 22 0,6-2B version spirometer (ERS 1993 Uptake + Zapleta, SensorMedics, Inc, Anaheim, CA, USA). Forced vital capacity (FVC) percent was recorded according to the American Thoracic Society (ATS) / European Respiratory Society (ERS) criteria
Change in Forced Expiratory Volume in One Second
Pulmonary function test was applied by Sensor Medics Vmax 22 0,6-2B version spirometer (ERS 1993 Uptake + Zapleta, SensorMedics, Inc, Anaheim, CA, USA). Forced expiratory volume in one second (FEV1) percent was recorded according to the American Thoracic Society (ATS) / European Respiratory Society (ERS) criteria
Change in Forced expiratory volume in one second / Forced vital capacity
Pulmonary function test was applied by Sensor Medics Vmax 22 0,6-2B version spirometer (ERS 1993 Uptake + Zapleta, SensorMedics, Inc, Anaheim, CA, USA). Forced expiratory volume in one second (FEV1)/Forced vital capacity (FVC) ratio percent was recorded according to the American Thoracic Society (ATS) / European Respiratory Society (ERS) criteria
Change in diffusion capacity
Single breath carbon monoxide method was used in diffusion capacity for carbon monoxide (DLCO) percent measurement
Change in Maximal Expiratory Pressure
Electronic mouth pressure measuring device was used for respiratory muscle strength. Maximal expiratory pressure (MEP) was measured. MEP was measured from total lung capacity performing a maximal expiratory effort against an occluded airway. MEP measurements was repeated three times, and the maximum percent achieved was recorded
Change in Maximal Inspiratory Pressure
Electronic mouth pressure measuring device was used for respiratory muscle strength. Maximal inspiratory pressure (MIP) was measured. MIP was measured from residual volume upon a maximal inspiratory effort against an occluded airway. occluded airway. MIP measurements was repeated three times, and the maximum percent achieved was recorded.
Change in functional capacity
Six-minute walk test (6MWT) is a valid, reliable and useful test for assessing functional capacity of patients. This test assesses distance walked over 6 minutes as a sub maximal test of aerobic capacity/endurance.
Change in peripheral muscle strength
The Jamar Handgrip Dynamometer is an instrument for measuring the maximum isometric strength of the hand and forearm muscles. Quadriceps isometric muscle strength is measured with a Hand Held Dynamometer.

Secondary Outcome Measures

Change in severity of dyspnoea
Modified Medical Research Council (mMRC) dyspnea scale is a valid and reliable test for measuring the severity of dyspnea. This scale ranges from 0 to 4. A higher value represents a worse outcome
Change in fatigue
The Fatigue Impact Scale that questions how much fatigue the scale has experienced in a month, taking as a reference a total of 40 items, including the day of application. Scores between 0 and 4 points are given for each item, and the maximum score is calculated to be 160.High score indicates a high level of fatigue.
Change in quality of life:Health Assessment Questionnaire Disability Index
Health Assessment Questionnaire Disability Index (HAQ-DI) measures disability, function and quality of life with 8 functional domains of physical capacity (dress / get up / eat / walk / hygiene / to reach objects / grip / activities) which consists of 20 items. Each item scored between 0 (without any difficulty) and 3 (unable to do). The scale is scored between 0 and 60 and the high score indicates poor health quality status
Change in quality of life: Scleroderma Health Assessment Questionnaire
The Scleroderma Health Assessment Questionnaire (SHAQ)-global score which was calculated by adding five SSc-related VAS to eight HAQ-DI domains and dividing the sum by 13. he subscales are scored between 0 and 3 and the high score indicates poor health status
Change in quality of life: Short Form-36 Quality of Life Questionnaire
SF-36 measures health-related quality of life and consists of 36 items in total and includes two subscales that are physical and mental. The subscales are scored between 0 and 100 and the low score indicates poor health status

Full Information

First Posted
November 25, 2020
Last Updated
April 13, 2021
Sponsor
Dokuz Eylul University
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1. Study Identification

Unique Protocol Identification Number
NCT04675502
Brief Title
Effects of a Supervised Exercise Program and a Home Exercise Program in Patients With Systemic Sclerosis
Official Title
Comparison of the Effects of a Supervised Exercise Program and a Home Exercise Program in Patients With Systemic Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 10, 2018 (Actual)
Primary Completion Date
April 13, 2021 (Actual)
Study Completion Date
April 13, 2021 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
Scleroderma, also called systemic sclerosis (SSc); It is a heterogeneous multiorgan disease of unknown etiology characterized by vasculopathy, autoimmunity and fibrous tissue. It is stated in studies that cardiac and pulmonary systems are affected in patients with SSc and these effects affect the aerobic capacity, physical functions and quality of life of patients negatively by disrupting their pulmonary and musculoskeletal functions. However, considering the treatment approaches in scleroderma patients, the number of studies evaluating the effectiveness of pulmonary rehabilitation and exercises is limited. Therefore, the purpose of our study; Comparison of the effects of a supervised exercise program and a home exercise program in patients with Systemic Sclerosis.
Detailed Description
Cases are divided into two groups as supervised exercise and home exercise program by closed envelope randomization method. All patients are informed about risk factors and risk factor management. All patients are trained 3 days in the first week under the supervision of a physiotherapist to learn individual exercise programs. Supervised exercise programs including warm-up, loading, cooling, and relaxation exercises are shown. The warm-up period is consist of light-paced walking, active movements of several large muscle groups. During the loading period respiratory control training, breathing exercises (Shrunken lip breathing exhaustion, diaphragmatic, thoracic expansion exercises), posture exercises with respiratory control (pectoral stretching, four-way trunk exercises, head-neck exercises, bilateral shoulder flexion and abduction exercises, sitting on a chair, standing up exercise. ), walking on the treadmill for 5-15 minutes without inclination and at a constant speed, starting with 3 minutes without load, continuing with a load of 20 watts and 3 minutes, and reaching a submaximal load with 3 watt increments every 10 seconds, pedaling in the bicycle ergometer is taken. Stretching exercises are done during the cooling period. This group was included in an exercise program 2 days a week, 45-90 minutes, for 12 weeks, accompanied by a specialist physiotherapist in the pulmonary rehabilitation unit in the chest diseases ward. The same exercises (respiratory control training, shrunken lip breathing exhaustion, diaphragmatic, thoracic expansion exercises, posture exercises with respiratory control (pectoral stretching, four-way trunk exercises, head and neck exercises, bilateral shoulder flexion and abduction exercises), sitting and standing exhaustion, and brisk walking to reach 60-85% of the person's maximum heart rate.)) were taught to the home exercise group and given in the form of a brochure and they were asked to do these exercises at home 2 days a week for 12 weeks. Participants of the home exercise group are contacted every two weeks via communication methods such as e-mail, message and telephone conversation. Exercise diary is given to all patients and is taken from them at the end of the study

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Sclerosis, Home Exercise, Aerobic Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supervised Exercise Group
Arm Type
Experimental
Arm Description
Exercise programs including warm-up, loading, cooling, and relaxation exercises are shown. The warm-up period is consist of light-paced walking, active movements of several large muscle groups. In this loading program; respiratory control training, breathing exercises, posture exercises with respiratory control , walking on the treadmill for 20 minutes without inclination , pedaling in the bicycle ergometer for 10 minutes is taken. Stretching exercises are done during the cooling period. This group was included in an exercise program 2 days a week, 45-90 minutes, for 12 weeks, accompanied by a specialist physiotherapist to the pulmonary rehabilitation unit in the chest diseases ward.
Arm Title
Home Exercise Group
Arm Type
Experimental
Arm Description
For patients to do at home (respiratory control training, shrunken lip breathing exhaustion, diaphragmatic, thoracic expansion exercises, posture exercises with respiratory control (pectoral stretching, four-way trunk exercises, head and neck exercises, bilateral shoulder flexion and abduction exercises), sitting and standing exhaustion, and brisk walking to reach 60-85% of the person's maximum heart rate.)), exercises is taught. Patients were asked to do the exercises at home for 45-90 minutes, 2 days a week, for 12 weeks. Participants of the control group are contacted every two weeks via communication methods such as e-mail, message and telephone conversation.Exercise diary is given to all patients and is taken from them at the end of the study.
Intervention Type
Other
Intervention Name(s)
supervised Exercise training
Intervention Description
warm-up, loading (respiratory control training, breathing exercises, posture exercises with respiratory control , walking on the treadmill for 20 minutes without inclination , pedaling in the bicycle ergometer for 10 minutes), cooling, and relaxation exercises
Intervention Type
Other
Intervention Name(s)
home exercise trainig
Intervention Description
Warm-up, loading (respiratory control training, shrunken lip breathing exhaustion, diaphragmatic, thoracic expansion exercises, posture exercises with respiratory control (pectoral stretching, four-way trunk exercises, head and neck exercises, bilateral shoulder flexion and abduction exercises), cooling and relaxation exercises
Primary Outcome Measure Information:
Title
Change in Forced Vital Capacity
Description
Pulmonary function test was applied by Sensor Medics Vmax 22 0,6-2B version spirometer (ERS 1993 Uptake + Zapleta, SensorMedics, Inc, Anaheim, CA, USA). Forced vital capacity (FVC) percent was recorded according to the American Thoracic Society (ATS) / European Respiratory Society (ERS) criteria
Time Frame
Baseline, 12th week
Title
Change in Forced Expiratory Volume in One Second
Description
Pulmonary function test was applied by Sensor Medics Vmax 22 0,6-2B version spirometer (ERS 1993 Uptake + Zapleta, SensorMedics, Inc, Anaheim, CA, USA). Forced expiratory volume in one second (FEV1) percent was recorded according to the American Thoracic Society (ATS) / European Respiratory Society (ERS) criteria
Time Frame
Baseline, 12th week
Title
Change in Forced expiratory volume in one second / Forced vital capacity
Description
Pulmonary function test was applied by Sensor Medics Vmax 22 0,6-2B version spirometer (ERS 1993 Uptake + Zapleta, SensorMedics, Inc, Anaheim, CA, USA). Forced expiratory volume in one second (FEV1)/Forced vital capacity (FVC) ratio percent was recorded according to the American Thoracic Society (ATS) / European Respiratory Society (ERS) criteria
Time Frame
Baseline, 12th week
Title
Change in diffusion capacity
Description
Single breath carbon monoxide method was used in diffusion capacity for carbon monoxide (DLCO) percent measurement
Time Frame
Baseline, 12th week
Title
Change in Maximal Expiratory Pressure
Description
Electronic mouth pressure measuring device was used for respiratory muscle strength. Maximal expiratory pressure (MEP) was measured. MEP was measured from total lung capacity performing a maximal expiratory effort against an occluded airway. MEP measurements was repeated three times, and the maximum percent achieved was recorded
Time Frame
Baseline, 12th week
Title
Change in Maximal Inspiratory Pressure
Description
Electronic mouth pressure measuring device was used for respiratory muscle strength. Maximal inspiratory pressure (MIP) was measured. MIP was measured from residual volume upon a maximal inspiratory effort against an occluded airway. occluded airway. MIP measurements was repeated three times, and the maximum percent achieved was recorded.
Time Frame
Baseline, 12th week
Title
Change in functional capacity
Description
Six-minute walk test (6MWT) is a valid, reliable and useful test for assessing functional capacity of patients. This test assesses distance walked over 6 minutes as a sub maximal test of aerobic capacity/endurance.
Time Frame
Baseline, 12th week
Title
Change in peripheral muscle strength
Description
The Jamar Handgrip Dynamometer is an instrument for measuring the maximum isometric strength of the hand and forearm muscles. Quadriceps isometric muscle strength is measured with a Hand Held Dynamometer.
Time Frame
Baseline, 12th week
Secondary Outcome Measure Information:
Title
Change in severity of dyspnoea
Description
Modified Medical Research Council (mMRC) dyspnea scale is a valid and reliable test for measuring the severity of dyspnea. This scale ranges from 0 to 4. A higher value represents a worse outcome
Time Frame
Baseline, 12th week
Title
Change in fatigue
Description
The Fatigue Impact Scale that questions how much fatigue the scale has experienced in a month, taking as a reference a total of 40 items, including the day of application. Scores between 0 and 4 points are given for each item, and the maximum score is calculated to be 160.High score indicates a high level of fatigue.
Time Frame
Baseline, 12th week
Title
Change in quality of life:Health Assessment Questionnaire Disability Index
Description
Health Assessment Questionnaire Disability Index (HAQ-DI) measures disability, function and quality of life with 8 functional domains of physical capacity (dress / get up / eat / walk / hygiene / to reach objects / grip / activities) which consists of 20 items. Each item scored between 0 (without any difficulty) and 3 (unable to do). The scale is scored between 0 and 60 and the high score indicates poor health quality status
Time Frame
Baseline, 12th week
Title
Change in quality of life: Scleroderma Health Assessment Questionnaire
Description
The Scleroderma Health Assessment Questionnaire (SHAQ)-global score which was calculated by adding five SSc-related VAS to eight HAQ-DI domains and dividing the sum by 13. he subscales are scored between 0 and 3 and the high score indicates poor health status
Time Frame
Baseline, 12th week
Title
Change in quality of life: Short Form-36 Quality of Life Questionnaire
Description
SF-36 measures health-related quality of life and consists of 36 items in total and includes two subscales that are physical and mental. The subscales are scored between 0 and 100 and the low score indicates poor health status
Time Frame
Baseline, 12th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Stable clinical status for at least two weeks Walking independently Volunteer for research study Exclusion Criteria: Having unstable angina Having uncontrolled hypertension Having hemodynamic instability Participating in any exercise program in the last six months Having a major orthopedic or neurological problem that limits functionality
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hazal Yakut, PT,MSc
Organizational Affiliation
Dokuz Eylul University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sevgi Özalevli, PT,PhD
Organizational Affiliation
Dokuz Eylul University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gerçek Can, MD
Organizational Affiliation
Dokuz Eylul University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Aylin Özgen Alpaydın, MD
Organizational Affiliation
Dokuz Eylul University
Official's Role
Study Chair
Facility Information:
Facility Name
Dokuz Eylül Üniversitesi School of Physical Therapy and Rehabilitation
City
İzmir
State/Province
İzmir, Turkey
ZIP/Postal Code
35340
Country
Turkey

12. IPD Sharing Statement

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Effects of a Supervised Exercise Program and a Home Exercise Program in Patients With Systemic Sclerosis

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