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

NCT07842133 | Recruiting

• 2 other identifiers: SCLERODERMA23.05.2025
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Skleroderma (Sistemik Skleroz

Keywords

Systemic sclerosis; Scleroderma; Progressive muscle relaxation; Fatigue; Dyspnea; Respiratory function; Relaxation exercise

Outcome Measures

Primary Outcomes (3)

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

  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.

  Baseline and 4 weeks after the intervention

• Fatigue severity measured by the FACIT-Fatigue Scale

  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.

  Baseline and 4 weeks after the intervention

• Dyspnea severity measured by the Dyspnea-12 (D-12) Scale

  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.

  Baseline and 4 weeks after the intervention

Study Arms (2)

Progressive Muscle Relaxation Exercise Group

EXPERIMENTAL

Participants randomly assigned to this group will receive progressive muscle relaxation exercises in addition to standard care.

Behavioral: Progressive Muscle Relaxation Exercise

Control Group

NO INTERVENTION

Participants randomly assigned to this group will receive standard care without progressive muscle relaxation exercises.

Interventions

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.

Progressive Muscle Relaxation Exercise Group

Eligibility Criteria

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

Sponsors & Collaborators

• University of Gaziantep: lead

Study Sites (1)

Gaziantep University Vocational School of Health Services

Gaziantep, Şehitkamil, 27000, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• Fairley JL, Hansen D, Proudman S, Baron M, Sahhar J, Ngian GS, Walker J, Host LV, Morrisroe K, Stevens W, Ross L, Nikpour M. The burden and determinants of fatigue in incident and prevalent systemic sclerosis. Clin Exp Rheumatol. 2024 Aug;42(8):1669-1674. doi: 10.55563/clinexprheumatol/6528od. Epub 2024 Aug 14.

  PMID: 39152749 RESULT

• Yakut H, Ozalevli S, Birlik AM. Fatigue and its relationship with disease-related factors in patients with systemic sclerosis: A cross-sectional study. Turk J Med Sci. 2021 Apr 30;51(2):530-539. doi: 10.3906/sag-2005-314.

  PMID: 32927933 RESULT

MeSH Terms

Conditions

Scleroderma, Systemic; Scleroderma, Diffuse; Fatigue; Dyspnea; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Pathologic Processes

Study Officials

• Adile Neşe, Associate Professor

  University of Gaziantep

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adile Neşe, Assoc Prof.

CONTACT

03423172187; acaparusagi@hotmail.com

Adile Neşe, Assoc Prof

CONTACT

03423172187; acaparusagi@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants and outcome assessors are blinded to group allocation. The researcher administering the intervention is aware of the group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be randomly assigned to either the progressive muscle relaxation exercise group or the control group. The intervention group will receive progressive muscle relaxation exercises, while the control group will receive standard care. Outcomes will be assessed and compared between the two groups before and after the intervention.

Study Record Dates

• First Submitted: September 20, 2026
• First Posted: September 25, 2026
• Study Start: April 25, 2026
• Primary Completion (Estimated): November 10, 2026
• Study Completion (Estimated): December 25, 2026
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)