Respiratory Muscle Training in Scleroderma

NCT ID: NCT06684132

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-10
• Study Completion Date: 2025-02-20

Brief Summary

The aim of this study is to investigate the effects of IMT on respiratory muscle strength, pulmonary function tests, quality of life aerobic capacity, dyspnea, fatigue and physical activity level in scleroderma patients with ILD. The study will include 30 Scleroderma + ILD patients who are under follow-up in Fırat University Rheumatology Department. Patients will be randomly divided into two groups. High intensity intermittent inspiratory muscle training (H-IMT) will be applied to the respiratory muscle training group in addition to the exercise program. Respiratory muscle strength will be assessed by maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP); aerobic capacity will be assessed by exercise test and VO2max. Dyspnea will be assessed with the Modified Medical Research Council Scale; fatigue with the Fatigue Severity Scale; quality of life with the Scleroderma Health Assessment Questionnaire; physical activity level with the International Physical Activity Scale - Short Form

Detailed Description

Inspiratory muscle training (IMT) is performed by inspiring against an external load provided by a device. It is easy to implement, low cost and can be easily integrated into rehabilitation programs. Pulmonary rehabilitation and inspiratory muscle training have been applied as an effective method in ILD. However, there are no studies investigating the effects of IMT in individuals with ILD. The aim of this study was to investigate the effects of IMT on respiratory muscle strength, pulmonary function tests, quality of life, aerobic capacity, dyspnea, fatigue and physical activity level in scleroderma patients with ILD. The study will include 30 Scleroderma + ILD patients who are under follow-up in Fırat University Rheumatology Department. Patients will be randomly divided into two groups. High intensity intermittent inspiratory muscle training (H-IMT) will be applied to the respiratory muscle training group in addition to the exercise program. This training will be performed with Power breath (POWERbreathe Classic Light Resistance, PowerBreath, IMT Technologies Ltd, Birmingham, UK) respiratory muscle training device. In the control group, only stretching, strengthening and posture exercises will be applied as a home program. Respiratory muscle strength will be assessed by maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP); aerobic capacity will be assessed by VO2max with exercise test. dyspnea will be assessed using the Modified Medical Research Council Scale; fatigue will be assessed using the Fatigue Severity Scale; quality of life will be assessed using the Scleroderma Health Assessment Questionnaire; physical activity level will be assessed using the International Physical Activity Scale - Short Form.

Conditions

Scleroderma (Limited and Diffuse)

Study Design

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

Study Groups

IMT group

High intensity intermittent inspiratory muscle training (H-IMT) will be applied. This training will be performed with Power breath (POWERbreathe Classic Light Resistance, PowerBreath, IMT Technologies Ltd, Birmingham, UK) respiratory muscle training device. The H-IMT will be performed in seven sets of three-minute cycles consisting of two minutes of training followed by one minute of rest in the training workload. Each session will consist of 14 minutes of loading and seven minutes of rest for a total of 21 minutes.

Group Type: EXPERIMENTAL

Inspiratory muscle training

Intervention Type: OTHER

The H-IMT will be performed in seven sets of three-minute cycles consisting of two minutes of training followed by one minute of rest in the training workload. Each session will consist of 14 minutes of loading and seven minutes of rest for a total of 21 minutes.

Exercise group

Stretching exercises for pectoral muscles, neck muscles and back muscles, strengthening exercises for upper extremity and back muscles and posture exercises will be applied.

Group Type: OTHER

Exercise

Intervention Type: OTHER

Stretching exercises for pectoral muscles, neck muscles and back muscles, strengthening exercises for upper extremity and back muscles and posture exercises will be applied.

Interventions

Inspiratory muscle training

The H-IMT will be performed in seven sets of three-minute cycles consisting of two minutes of training followed by one minute of rest in the training workload. Each session will consist of 14 minutes of loading and seven minutes of rest for a total of 21 minutes.

Intervention Type: OTHER

Exercise

Stretching exercises for pectoral muscles, neck muscles and back muscles, strengthening exercises for upper extremity and back muscles and posture exercises will be applied.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 18-65 years old
• Patients whose medical treatment has not changed in the last three months
• Patients who volunteered to participate in the study and were cooperative
• Literate patients
• Patients followed with a diagnosis of SSc

Exclusion Criteria

• Patients who are pregnant
• Patients with a diagnosis of malignancy
• Patients with other concomitant systemic inflammatory rheumatic diseases
• Patients with neurological, orthopedic or congenital problems that prevent physical activity

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Firat University

OTHER

Sponsor Role: lead

Responsible Party

Songül Bağlan Yentür

Firat University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Songul Baglan Yentur

Role: CONTACT

songulbaglan23@hotmail.com

+90 4242370000

Other Identifiers

2024/13-06

Identifier Type: -

Identifier Source: org_study_id