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NCT Number: NCT07512895

The Effect of Progressive Muscle Relaxation Exercises on Depression and Fatigue in Patients Receiving Hemodialysis Treatment: A Randomized Controlled Trial

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Aydın Universty, Istanbul, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

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

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Treatment and study plan

Progressive Muscle Relaxation Intervention

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Piper Fatigue Scale (PFS):

    Time frame: 12 week

    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

Other outcomes

  1. Progressive Muscle Relaxation Intervention

    Time frame: 12 week

    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 conducted face-to-face by the researchers, after which instructional videos were shared through a WhatsApp group created for participants. Reminders were provided before each session.

Study contacts

Contact information is provided by the study sponsor or research team.

ARZU KAVALA, Assistant Prof

CONTACT

[email protected]

+905445418208

Sponsors and collaborators

Lead sponsor

Istanbul Aydın University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 6, 2026
Registry last updated
Apr 6, 2026

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

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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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