Respiratory Muscle Training in Scleroderma

NCT06684132 | Not Yet Recruiting

• 1 other identifier: 2024/13-06
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Conditions

Scleroderma (Limited and Diffuse)

Keywords

Scleroderma; Inspiratory muscle training; pulmonary functions

Outcome Measures

Primary Outcomes (1)

• Respiratory muscle strength

  Respiratory muscle strength will be assessed with an intraoral pressure gauge. Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP) are commonly used non-invasive methods to determine respiratory muscle strength. These are intraoral pressures measured at maximum respiration against a valve that closes the airways. When applying MIP, the patient is asked to perform maximal expiration.

  up to 8 weeks

Secondary Outcomes (1)

• Fatigue

  up to 8 weeks

Study Arms (2)

IMT group

EXPERIMENTAL

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.

Other: Inspiratory muscle training

Exercise group

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.

Other: Exercise

Interventions

Inspiratory muscle training 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.

IMT group

Exercise 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.

Exercise group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Firat University: lead

MeSH Terms

Conditions

Scleroderma, Diffuse

Interventions

Exercise

Condition Hierarchy (Ancestors)

Scleroderma, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Songul Baglan Yentur

CONTACT

+90 4242370000; songulbaglan23@hotmail.com

Study Design

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

Study Record Dates

• First Submitted: November 8, 2024
• First Posted: November 12, 2024
• Study Start: November 10, 2024
• Primary Completion: January 10, 2025
• Study Completion: February 20, 2025
• Last Updated: November 12, 2024

Record last verified: 2024-11