Systemic Sclerosis (SSc)PMR-SCLERODERMNCT07842133
The Effect of Progressive Muscle Relaxation Exercises on Fatigue, Dyspnea, and Respiratory Function in Patients With Systemic Sclerosis
A study testing Progressive Muscle Relaxation Exercise in people with Systemic Sclerosis (SSc), run by University of Gaziantep at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Sclerosis (SSc)
- What is being tested?
- Progressive Muscle Relaxation Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Apr 2026to 25 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
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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Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gaziantep University Vocational School of Health Services
Gaziantep, Şehitkamil, 27000
Adile Neşe, Associate Professor, 03423172187, acaparusagi@hotmail.com
Adile Neşe, Associate Professor
About this study
Official title: The Effect of Progressive Muscle Relaxation Exercises on Fatigue, Dyspnea, and Respiratory Function in Patients With Systemic Sclerosis: A Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Systemic Sclerosis (SSc)
- Being tested
- Progressive Muscle Relaxation Exercise
- Keywords
- Systemic sclerosis; Scleroderma; Progressive muscle relaxation; Fatigue; Dyspnea;
- Medical subject headings
- Scleroderma, Systemic, Scleroderma, Diffuse, Fatigue, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Muscle Relaxation ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Progressive Muscle Relaxation Exercise Group | Experimental | Participants randomly assigned to this group will receive progressive muscle relaxation exercises in addition to standard care. Receives: Behavioral: Progressive Muscle Relaxation Exercise |
| Control Group | No intervention | Participants randomly assigned to this group will receive standard care without progressive muscle relaxation exercises. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and 4 weeks after the intervention
Secondary outcomes (1)
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.
Measured: Baseline and 4 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start25 Apr 2026
- Primary completion10 Nov 2026 (estimated)
- Study completion25 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Systemic Sclerosis (SSc)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adile Nese, University of Gaziantep
- Investigators
- Adile Neşe, Associate Professor, Principal investigator, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07842133
- Sponsor's protocol ID
- SCLERODERMA
- Other IDs
- 23.05.2025
- Acronym
- PMR-SCLERODERM
- Status last verified
- Sep 2026
- First submitted
- 20 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers. Data will be used only for the purposes of this study and will be handled in accordance with applicable ethical and data protection requirements.
Publications
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.
PubMed 39152749Yakut 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.
PubMed 32927933
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progressive Muscle Relaxation Exercises on Fatigue, Dyspnea, and Respiratory Function in Patients With Systemic Sclerosis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07842133
- Acronym / sponsor ID
- PMR-SCLERODERM / SCLERODERMA
- Conditions
- Systemic Sclerosis (SSc)
- Keywords
- Systemic sclerosis; Scleroderma; Progressive muscle relaxation; Fatigue; Dyspnea;
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 25 Apr 2026 (actual)
- Primary completion
- 10 Nov 2026 (estimated)
- Study completion
- 25 Dec 2026 (estimated)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Progressive Muscle Relaxation Exercise Group | Experimental | Behavioral: Progressive Muscle Relaxation ExerciseParticipants randomly assigned to this group will receive progressive muscle relaxation exercises in addition to standard care. |
| Control Group | No intervention | –Participants randomly assigned to this group will receive standard care without progressive muscle relaxation exercises. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive Muscle Relaxation ExerciseParticipants 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. | Behavioural | Progressive Muscle Relaxation Exercise Group |
Primary outcome
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.
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Results publication: PubMed 39152749Fairley 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.
- Results publication: PubMed 32927933Yakut 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers. Data will be used only for the purposes of this study and will be handled in accordance with applicable ethical and data protection requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adile Neşe, Associate Professor principal investigator
University of Gaziantep
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Muscle Relaxation Exercise in people with Systemic Sclerosis (SSc), run by University of Gaziantep at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adile Neşe, Assoc Prof. (03423172187, acaparusagi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue severity measured by the FACIT-Fatigue Scale (time frame: Baseline and 4 weeks after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07842133, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.