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

NCT04675502 | Completed DMC

• 1 other identifier: 3701-GOA
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Sclerosis; Home Exercise; Aerobic Exercise

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• Change in diffusion capacity

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

  Baseline, 12th week

• 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

• 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

• 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

• 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 Outcomes (5)

• Change in severity of dyspnoea

  Baseline, 12th week

• Change in fatigue

  Baseline, 12th week

• Change in quality of life:Health Assessment Questionnaire Disability Index

  Baseline, 12th week

• Change in quality of life: Scleroderma Health Assessment Questionnaire

  Baseline, 12th week

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

  Baseline, 12th week

Study Arms (2)

Supervised Exercise Group

EXPERIMENTAL

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.

Other: supervised Exercise training

Home Exercise Group

EXPERIMENTAL

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.

Other: home exercise trainig

Interventions

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

Supervised Exercise Group

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

Home Exercise Group

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Dokuz Eylül Üniversitesi School of Physical Therapy and Rehabilitation

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

Location

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Hazal Yakut, PT,MSc

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

• Sevgi Özalevli, PT,PhD

  Dokuz Eylul University

  STUDY DIRECTOR

• Gerçek Can, MD

  Dokuz Eylul University

  STUDY CHAIR

• Aylin Özgen Alpaydın, MD

  Dokuz Eylul University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: December 19, 2020
• Study Start: June 10, 2018
• Primary Completion: April 13, 2021
• Study Completion: April 13, 2021
• Last Updated: April 14, 2021

Record last verified: 2021-02

Locations

TU (1)