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

Systemic Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04675502
• Other study ID #: 3701-GOA
• Status: Completed
• Phase: N/A
• Start date: June 10, 2018
• Est. completion date: April 13, 2021

Study information

• Verified date: February 2021
• Source: Dokuz Eylul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: April 13, 2021
• Est. primary completion date: April 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Aerobic Exercise
• Home Exercise
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Other:
• 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
• 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

Locations

Country	Name	City	State
Turkey	Dokuz Eylül Üniversitesi School of Physical Therapy and Rehabilitation	Izmir	Izmir, Turkey

Sponsors (1)

Lead Sponsor	Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline, 12th week
Primary	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	Baseline, 12th week
Primary	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	Baseline, 12th week
Primary	Change in diffusion capacity	Single breath carbon monoxide method was used in diffusion capacity for carbon monoxide (DLCO) percent measurement	Baseline, 12th week
Primary	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	Baseline, 12th week
Primary	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.	Baseline, 12th week
Primary	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.	Baseline, 12th week
Primary	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.	Baseline, 12th week
Secondary	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	Baseline, 12th week
Secondary	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.	Baseline, 12th week
Secondary	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	Baseline, 12th week
Secondary	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	Baseline, 12th week
Secondary	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	Baseline, 12th week