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NCT Number: NCT07842133

The Effect of Progressive Muscle Relaxation Exercises on Fatigue, Dyspnea, and Respiratory Function in Patients With Systemic Sclerosis

This study aims to evaluate the effects of progressive muscle relaxation exercises on fatigue, dyspnea, and respiratory function in patients with systemic sclerosis. Participants will be assessed before and after the intervention.

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Key information

Conditions

Skleroderma (Sistemik Skleroz Connective Tissue Diseases Dyspnea Fatigue Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Scleroderma, Diffuse Scleroderma, Systemic Signs and Symptoms Signs and Symptoms, Respiratory Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gaziantep University Vocational School of Health Services

Gaziantep, Şehitkamil, 27000, Turkey (Türkiye)

Location status: Recruiting

About this study

Systemic sclerosis is a chronic autoimmune connective tissue disease that can affect multiple organs, including the respiratory system. Respiratory involvement may lead to symptoms such as dyspnea and fatigue and may adversely affect respiratory function and quality of life.

Progressive muscle relaxation exercise is a non-pharmacological relaxation technique that involves systematically tensing and relaxing different muscle groups. This technique may reduce physical and psychological tension and may contribute to the management of symptoms such as fatigue and dyspnea.

The purpose of this study is to evaluate the effect of progressive muscle relaxation exercises on fatigue, dyspnea, and respiratory function in patients with systemic sclerosis. Participants will undergo baseline assessments before the intervention. Progressive muscle relaxation exercises will then be administered, followed by post-intervention assessments to determine changes in fatigue, dyspnea, and respiratory function.

The findings of this study may provide evidence regarding the potential use of progressive muscle relaxation exercises as a supportive non-pharmacological intervention for symptom management in patients with systemic sclerosis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Individuals who meet the study eligibility criteria will be included in the study. Eligible participants will be adults aged 18 years or older, diagnosed with systemic sclerosis, and have adequate physical and cognitive capacity to participate in the study.

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Exclusion criteria

Individuals who do not meet the inclusion criteria, who are unable to participate in the progressive muscle relaxation exercises due to their physical or cognitive condition, or who withdraw from the study voluntarily will be excluded from the study.

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Treatment and study plan

Progressive Muscle Relaxation Exercise

Behavioral

Participants in the intervention group will receive progressive muscle relaxation exercises according to the study protocol. The intervention will be administered in addition to standard care.

Primary outcomes

  1. Respiratory function measured by forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC)

    Time frame: Baseline and 4 weeks after the intervention

    Respiratory function will be assessed using spirometry, including forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC). Changes in FEV1 and FVC from baseline to post-intervention assessment will be evaluated between the intervention and control groups.

  2. Fatigue severity measured by the FACIT-Fatigue Scale

    Time frame: Baseline and 4 weeks after the intervention

    Fatigue will be assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scale. Changes in fatigue scores from baseline to post-intervention assessment will be evaluated between the intervention and control groups.

  3. Dyspnea severity measured by the Dyspnea-12 (D-12) Scale

    Time frame: Baseline and 4 weeks after the intervention

    Dyspnea will be assessed using the Dyspnea-12 (D-12) Scale. Changes in dyspnea scores from baseline to post-intervention assessment will be evaluated between the intervention and control groups.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University of Gaziantep

Other

Registry information

Official study title

The Effect of Progressive Muscle Relaxation Exercises on Fatigue, Dyspnea, and Respiratory Function in Patients With Systemic Sclerosis: A Randomized Controlled Trial

Acronym: PMR-SCLERODERM

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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