Skip to main content
OpenTrials
Completed

NCT Number: NCT04675502

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Systemic Sclerosis Aerobic Exercise Connective Tissue Diseases Home Exercise Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dokuz Eylül Üniversitesi School of Physical Therapy and Rehabilitation

Izmir, İzmir, Turkey, 35340, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supervised Exercise training

Other

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

home exercise trainig

Other

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 outcomes

  1. Change in Forced Vital Capacity

    Time frame: Baseline, 12th week

    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

  2. Change in Forced Expiratory Volume in One Second

    Time frame: Baseline, 12th week

    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

  3. Change in Forced expiratory volume in one second / Forced vital capacity

    Time frame: Baseline, 12th week

    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

  4. Change in diffusion capacity

    Time frame: Baseline, 12th week

    Single breath carbon monoxide method was used in diffusion capacity for carbon monoxide (DLCO) percent measurement

  5. Change in Maximal Expiratory Pressure

    Time frame: Baseline, 12th week

    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

  6. Change in Maximal Inspiratory Pressure

    Time frame: Baseline, 12th week

    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.

  7. Change in functional capacity

    Time frame: Baseline, 12th week

    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.

  8. Change in peripheral muscle strength

    Time frame: Baseline, 12th week

    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 outcomes

  1. Change in severity of dyspnoea

    Time frame: Baseline, 12th week

    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

  2. Change in fatigue

    Time frame: Baseline, 12th week

    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.

  3. Change in quality of life:Health Assessment Questionnaire Disability Index

    Time frame: Baseline, 12th week

    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

  4. Change in quality of life: Scleroderma Health Assessment Questionnaire

    Time frame: Baseline, 12th week

    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

  5. Change in quality of life: Short Form-36 Quality of Life Questionnaire

    Time frame: Baseline, 12th week

    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

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Dec 19, 2020
Registry last updated
Apr 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.