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

NCT ID: NCT04675502

Last Updated: 2021-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-10
• Study Completion Date: 2021-04-13

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

Conditions

Systemic Sclerosis; Home Exercise; Aerobic Exercise

Study Design

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

Study Groups

Supervised Exercise Group

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.

Group Type: EXPERIMENTAL

supervised Exercise training

Intervention Type: 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 Group

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.

Group Type: EXPERIMENTAL

home exercise trainig

Intervention Type: 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

Interventions

supervised Exercise training

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

home exercise trainig

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dokuz Eylul University

OTHER

Sponsor Role: lead

Responsible Party

Hazal Yakut

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hazal Yakut, PT,MSc

Role: PRINCIPAL_INVESTIGATOR

Dokuz Eylul University

Sevgi Özalevli, PT,PhD

Role: STUDY_DIRECTOR

Dokuz Eylul University

Gerçek Can, MD

Role: STUDY_CHAIR

Dokuz Eylul University

Aylin Özgen Alpaydın, MD

Role: STUDY_CHAIR

Dokuz Eylul University

Locations

Dokuz Eylül Üniversitesi School of Physical Therapy and Rehabilitation

Izmir, İzmir, Turkey, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

3701-GOA

Identifier Type: -

Identifier Source: org_study_id