Hemodialysis ComplicationNCT07512895
The Effect of Progressive Muscle Relaxation Exercises on Depression and Fatigue in Patients Receiving Hemodialysis Treatment: A Randomized Controlled Trial
A study testing Progressive Muscle Relaxation Intervention in people with Hemodialysis Complication and Hemodialysis, run by Istanbul Aydın University at 2 sites in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effects of progressive muscle relaxation exercises on depression and fatigue levels in patients undergoing hemodialysis treatment. Progressive muscle relaxation is applied as an individualized non-pharmacological intervention, and its potential contribution to psychological well-being… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemodialysis Complication, Hemodialysis
- What is being tested?
- Progressive Muscle Relaxation Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Dec 2025to 1 May 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Scoring 4 or above on the First-Level Beck Depression Inventory
- Patients who regularly receive hemodialysis treatment
- Individuals who are cognitively capable of understanding the exercise instructions
- Individuals who voluntarily agree to participate in the study and provide informed consent
Who cannot join
- Individuals diagnosed with a psychiatric disorder (e.g., major depression, bipolar disorder, schizophrenia, etc.)
- Individuals who are physically unable to perform relaxation exercises due to musculoskeletal disorders
- Individuals who have previously participated regularly in relaxation therapy, yoga, meditation, or similar practices
- Individuals who cannot follow instructions due to hearing, visual, or cognitive impairments
- Individuals who are simultaneously participating in another psychosocial or physical intervention program
- -
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Istanbul Aydın Universty
Istanbul, Istanbul
Arzu Kavala, Assistant Prof, +905445418208, arzukavala@aydin.edu.tr
- Recruiting
Arzu Kavala
Istanbul
Arzu Kavala, +905445418208
About this study
This study aims to evaluate the effects of progressive muscle relaxation exercises on depression and fatigue levels in patients undergoing hemodialysis treatment. Progressive muscle relaxation is applied as an individualized non-pharmacological intervention, and its potential contribution to psychological well-being is investigated. The study seeks to determine whether regular relaxation exercises can reduce depressive symptoms, alleviate fatigue, and improve overall emotional well-being in hemodialysis patients. Findings from this research are expected to provide evidence for the use of relaxation-based interventions as supportive care methods in the management of psychological symptoms associated with chronic kidney disease and hemodialysis.
Read the detailed description
Hemodialysis is a vital treatment modality for patients with kidney failure, extending life expectancy and reducing associated symptoms. However, it also introduces significant physical, psychological, and social challenges for patients. Fatigue, one of the most frequently reported symptoms among hemodialysis patients, substantially impairs daily functioning and quality of life, with studies indicating that 42% to 89% of these individuals experience clinically relevant fatigue levels.
In addition to physical symptoms, anxiety and depression are common psychological problems among hemodialysis patients. These symptoms are closely linked to fatigue and sleep disturbances. Depression often presents with persistent fatigue and low energy, whereas insomnia can contribute to the onset or exacerbation of fatigue, anxiety, and depressive symptoms. Globally, approximately 280 million people are affected by depression, with significant prevalence among adults and older adults. Depression is a major contributor to disability worldwide and is projected to become the leading cause of disease burden by 2030. In a study involving 55,982 patients with chronic kidney disease, nearly one-quarter were found to experience depression, with even higher rates reported among those receiving maintenance hemodialysis. Current evidence indicates that the prevalence of depression in this population ranges from 20% to 47%.
Progressive Muscle Relaxation (PMR), first introduced by Jacobson in 1924, is a technique aimed at achieving physical and mental relaxation through systematic tensing and releasing of muscle groups. Research has shown that relaxation practices reduce oxygen consumption, heart rate, respiratory rate, and muscle tension while alleviating pain perception and lowering stress responses through increased endorphin production. Ortega et al. (2021) highlighted that PMR enhances awareness of bodily sensations and reduces tension, while Ramaiah and Albokhary (2021) demonstrated that progressive relaxation and similar home-based practices significantly decreased menstrual pain severity through increased blood flow and suppression of sympathetic nervous system activity. These findings suggest that PMR can serve as an effective complementary approach for both physical and psychological symptoms.
The present study aims to evaluate the effects of progressive muscle relaxation exercises on depression and fatigue levels in patients undergoing hemodialysis. Specifically, it investigates whether this individualized intervention contributes to improved psychological well-being among hemodialysis patients.
- Conditions
- Hemodialysis Complication, Hemodialysis
- Being tested
- Progressive Muscle Relaxation Intervention
- Keywords
- Depression, Hemodialysis, Progressive Muscle Relaxation Exercises, Fatigue
- Medical subject headings
- Depression, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Muscle Relaxation InterventionBehavioural
The study population consisted of all patients receiving treatment at the center during the study period. Instead of a statistical sample size calculation, a total population sampling method was used. All voluntary patients who met the inclusion criteria and were receiving hemodialysis at the center during the specified time frame were included. Among patients who scored 4 or above on the First-Level Beck Depression Inventory, an independent nurse not involved in the research team assigned unique codes. A computer-generated random number table was then used to allocate participants into the intervention group (30 patients) and control group (30 patients) in a 1:1 ratio.Progressive muscle relaxation exercises were used as the relaxation technique. Participants were instructed to assume a comfortable position, and all instructions were delivered clearly and understandably. The exercise program was planned for 8 weeks, 3 days per week, for 30 minutes per session. The first session was con
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Progressive muscle relaxation exercise will be applied to the experimental group. Receives: Behavioral: Progressive Muscle Relaxation Intervention |
| Control Group | No intervention | No Interventıon |
What is being measured
The primary outcome is the main question the study is designed to answer.
First-Level Beck Depression Screening Inventory (BDÖ-BB):
The Turkish validity and reliability study was conducted by Aktürk et al. (2005). The scale includes seven subdimensions: sadness, pessimism, past failures, self-dislike, self-blame, loss of interest, and suicidal thoughts or desires. Patients evaluate their experiences over the past two weeks. Each item includes four response options scored between 0 and 3. The maximum total score is 21, and higher scores indicate greater depressive symptoms. Scores above 4 suggest a depression probability of over 90%. This cutoff was used in the present study. Cronbach's alpha, Spearman-Brown, and Guttman Split-Half coefficients were reported as 0.85, 0.86, and 0.82, respectively.
Measured: 12 week
Secondary outcomes (1)
Piper Fatigue Scale (PFS):
Developed by Piper et al. (1998), this 22-item scale includes four subdimensions: behavioral/severity, affective meaning, sensory, and cognitive/mood. Items are scored between 1 (mild) and 10 (severe), and higher scores indicate higher perceived fatigue. The Turkish validity and reliability study by Can (2004) reported a Cronbach's alpha of 0.94
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start1 Dec 2025
- Primary completion1 Apr 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis ComplicationStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Aydın University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ARZU KAVALA, Istanbul Aydın University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07512895
- Sponsor's protocol ID
- ARZU KAVALA
- Status last verified
- Apr 2026
- First submitted
- 26 Mar 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It will be shared when necessary.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progressive Muscle Relaxation Exercises on Depression and Fatigue in Patients Receiving Hemodialysis Treatment: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07512895
- Acronym / sponsor ID
- ARZU KAVALA
- Conditions
- Hemodialysis Complication, Hemodialysis
- Keywords
- Depression, Hemodialysis, Progressive Muscle Relaxation Exercises, Fatigue
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istanbul Aydın UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 6 Apr 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 depression and fatigue levels in patients undergoing hemodialysis treatment. Progressive muscle relaxation is applied as an individualized non-pharmacological intervention, and its potential contribution to psychological well-being is investigated. The study seeks to determine whether regular relaxation exercises can reduce depressive symptoms, alleviate fatigue, and improve overall emotional well-being in hemodialysis patients. Findings from this research are expected to provide evidence for the use of relaxation-based interventions as supportive care methods in the management of psychological symptoms associated with chronic kidney disease and hemodialysis.
Detailed description
Hemodialysis is a vital treatment modality for patients with kidney failure, extending life expectancy and reducing associated symptoms. However, it also introduces significant physical, psychological, and social challenges for patients. Fatigue, one of the most frequently reported symptoms among hemodialysis patients, substantially impairs daily functioning and quality of life, with studies indicating that 42% to 89% of these individuals experience clinically relevant fatigue levels.
In addition to physical symptoms, anxiety and depression are common psychological problems among hemodialysis patients. These symptoms are closely linked to fatigue and sleep disturbances. Depression often presents with persistent fatigue and low energy, whereas insomnia can contribute to the onset or exacerbation of fatigue, anxiety, and depressive symptoms. Globally, approximately 280 million people are affected by depression, with significant prevalence among adults and older adults. Depression is a major contributor to disability worldwide and is projected to become the leading cause of disease burden by 2030. In a study involving 55,982 patients with chronic kidney disease, nearly one-quarter were found to experience depression, with even higher rates reported among those receiving maintenance hemodialysis. Current evidence indicates that the prevalence of depression in this population ranges from 20% to 47%.
Progressive Muscle Relaxation (PMR), first introduced by Jacobson in 1924, is a technique aimed at achieving physical and mental relaxation through systematic tensing and releasing of muscle groups. Research has shown that relaxation practices reduce oxygen consumption, heart rate, respiratory rate, and muscle tension while alleviating pain perception and lowering stress responses through increased endorphin production. Ortega et al. (2021) highlighted that PMR enhances awareness of bodily sensations and reduces tension, while Ramaiah and Albokhary (2021) demonstrated that progressive relaxation and similar home-based practices significantly decreased menstrual pain severity through increased blood flow and suppression of sympathetic nervous system activity. These findings suggest that PMR can serve as an effective complementary approach for both physical and psychological symptoms.
The present study aims to evaluate the effects of progressive muscle relaxation exercises on depression and fatigue levels in patients undergoing hemodialysis. Specifically, it investigates whether this individualized intervention contributes to improved psychological well-being among hemodialysis patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Progressive Muscle Relaxation InterventionProgressive muscle relaxation exercise will be applied to the experimental group. |
| Control Group | No intervention | –No Interventıon |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Scoring 4 or above on the First-Level Beck Depression Inventory
- Patients who regularly receive hemodialysis treatment
- Individuals who are cognitively capable of understanding the exercise instructions
- Individuals who voluntarily agree to participate in the study and provide informed consent
Key exclusion criteria (6 listed)
- Individuals diagnosed with a psychiatric disorder (e.g., major depression, bipolar disorder, schizophrenia, etc.)
- Individuals who are physically unable to perform relaxation exercises due to musculoskeletal disorders
- Individuals who have previously participated regularly in relaxation therapy, yoga, meditation, or similar practices
- Individuals who cannot follow instructions due to hearing, visual, or cognitive impairments
- Individuals who are simultaneously participating in another psychosocial or physical intervention program
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 InterventionThe study population consisted of all patients receiving treatment at the center during the study period. Instead of a statistical sample size calculation, a total population sampling method was used. All voluntary patients who met the inclusion criteria and were receiving hemodialysis at the center during the specified time frame were included. Among patients who scored 4 or above on the First-Level Beck Depression Inventory, an independent nurse not involved in the research team assigned unique codes. A computer-generated random number table was then used to allocate participants into the intervention group (30 patients) and control group (30 patients) in a 1:1 ratio.Progressive muscle relaxation exercises were used as the relaxation technique. Participants were instructed to assume a comfortable position, and all instructions were delivered clearly and understandably. The exercise program was planned for 8 weeks, 3 days per week, for 30 minutes per session. The first session was con | Behavioural | Experimental Group |
Primary outcome
First-Level Beck Depression Screening Inventory (BDÖ-BB):
Time frame: 12 week
The Turkish validity and reliability study was conducted by Aktürk et al. (2005). The scale includes seven subdimensions: sadness, pessimism, past failures, self-dislike, self-blame, loss of interest, and suicidal thoughts or desires. Patients evaluate their experiences over the past two weeks. Each item includes four response options scored between 0 and 3. The maximum total score is 21, and higher scores indicate greater depressive symptoms. Scores above 4 suggest a depression probability of over 90%. This cutoff was used in the present study. Cronbach's alpha, Spearman-Brown, and Guttman Split-Half coefficients were reported as 0.85, 0.86, and 0.82, respectively.
1 secondary outcome
Piper Fatigue Scale (PFS):
Time frame: 12 week
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 6 Apr 2026.
- Individual participant dataSharing planned: No. It will be shared when necessary.
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Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis
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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.
2 sites 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 Intervention in people with Hemodialysis Complication and Hemodialysis, run by Istanbul Aydın University at 2 sites 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?
The sponsor lists 4 inclusion and 6 exclusion criteria. 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 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 ARZU KAVALA, Assistant Prof (+905445418208, arzukavala@aydin.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First-Level Beck Depression Screening Inventory (BDÖ-BB): (time frame: 12 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2026.