Muscle Cramps in Hemodialysis Patients: A Randomized Controlled Trial

NCT06866470 | Not Yet Recruiting

• 1 other identifier: tXazkY4r
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Muscle cramps are a common and distressing issue among hemodialysis patients, significantly impacting their quality of life. Non-pharmacological approaches are increasingly being explored to alleviate these symptoms. Massage therapy and progressive muscle relaxation exercises are among the interventions that may help reduce the frequency and severity of cramps by promoting muscle relaxation. However, their effectiveness in hemodialysis patients has not been sufficiently studied. This randomized controlled trial aims to evaluate the effects of massage and progressive muscle relaxation exercises on the frequency and severity of muscle cramps in hemodialysis patients. The findings are expected to contribute to evidence-based practices in symptom management.

Conditions

Nursing Caries; Hemodialysis Complication; Exercise Addiction

Outcome Measures

Primary Outcomes (1)

• pain report

  pain measurement scale report

  3 months

Study Arms (1)

stretching exercise group

EXPERIMENTAL

stretching exercise group

Behavioral: relaxation group

Interventions

relaxation group BEHAVIORAL

exercise group

stretching exercise group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Receiving Hemodialysis Treatment: Patients who have been undergoing regular hemodialysis treatment for at least six months.
• History of Muscle Cramps: Patients who have experienced muscle cramps at least twice a week in the past month.
• Age Range: Between 18 and 75 years old. Must be able to swallow tablets Cognitive and Physical Suitability: Having the cognitive and physical capacity to understand and perform massage and progressive muscle relaxation exercises.
• Stable Cardiovascular Condition: No history of myocardial infarction or severe cardiovascular complications in the past three months.
• Stable Medical Condition: No acute or severe medical conditions other than dialysis treatment.
• Voluntary Participation: Signing the informed consent form after being fully informed about the study.

You may not qualify if:

• Insulin dependent diabetes Thyroid disease Clinical diagnosis of Alzheimer's Disease
• Neuromuscular Disorders: Presence of conditions such as multiple sclerosis, Parkinson's disease, or peripheral neuropathy.
• Severe Cardiovascular Diseases: History of myocardial infarction, congestive heart failure (NYHA class III-IV), or uncontrolled hypertension in the past three months.
• Severe Orthopedic or Rheumatic Conditions: Severe osteoarthritis, rheumatoid arthritis, or other chronic musculoskeletal disorders.
• Acute Infections or Inflammatory Conditions: Diagnosis of an active infection or inflammatory disease during the study period.
• Mental or Psychiatric Disorders: Presence of severe cognitive impairment, dementia, or major depression/anxiety.
• End-Stage Cancer Diagnosis: Undergoing active cancer treatment or having metastatic cancer.
• Contraindications to Massage or Relaxation Exercises: Presence of skin infections, open wounds, or any medical condition preventing massage or exercise application.
• Regular Use of Alternative Therapies: Engaging in regular massage therapy, yoga, or similar relaxation techniques within the past three months.
• Pregnancy: Being pregnant or in the breastfeeding period. Inability to Comply with the Study: Difficulty in attending the study regularly or adhering to the assigned interventions.

Sponsors & Collaborators

• University of Yalova: lead

Study Officials

• gürcan solmaz

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

Central Study Contacts

gürcan solmaz

CONTACT

05556287897; gurcan.solmaz@iuc.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 10, 2025
• Study Start: April 5, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 30, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share