Clinical trial NCT04675502: 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
Overall status: COMPLETED
Phase: NA
Conditions: Systemic Sclerosis
Home Exercise
Aerobic Exercise
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2020-12-19
Enrollment: 37
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Change in Forced Vital Capacity
timeFrame: Baseline, 12th week
measure: Change in Forced Expiratory Volume in One Second
timeFrame: Baseline, 12th week
measure: Change in Forced expiratory volume in one second / Forced vital capacity
timeFrame: Baseline, 12th week
measure: Change in diffusion capacity
timeFrame: Baseline, 12th week
measure: Change in Maximal Expiratory Pressure
timeFrame: Baseline, 12th week
measure: Change in Maximal Inspiratory Pressure
timeFrame: Baseline, 12th week
measure: Change in functional capacity
timeFrame: Baseline, 12th week
measure: Change in peripheral muscle strength
timeFrame: Baseline, 12th week
Secondary outcomes:
measure: Change in severity of dyspnoea
timeFrame: Baseline, 12th week
measure: Change in fatigue
timeFrame: Baseline, 12th week
measure: Change in quality of life:Health Assessment Questionnaire Disability Index
timeFrame: Baseline, 12th week
measure: Change in quality of life: Scleroderma Health Assessment Questionnaire
timeFrame: Baseline, 12th week
measure: Change in quality of life: Short Form-36 Quality of Life Questionnaire
timeFrame: Baseline, 12th week
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Dokuz Eylül Üniversitesi School of Physical Therapy and Rehabilitation
state: İzmir, Turkey
Study officials:
affiliation: Dokuz Eylul University
name: Hazal Yakut, PT,MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Dokuz Eylul University
name: Sevgi Özalevli, PT,PhD
role: STUDY_DIRECTOR
affiliation: Dokuz Eylul University
name: Gerçek Can, MD
role: STUDY_CHAIR
affiliation: Dokuz Eylul University
name: Aylin Özgen Alpaydın, MD
role: STUDY_CHAIR
References: