A Comparative Study of Intradialytic vs. Pre-Dialysis Physical Therapy Interventions in Individuals Undergoing Hemodialysis: A Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Physical Therapy Exercise Program.
- Who it may be relevant to
- Registry conditions: End-stage Renal Disease (ESRD), Chronic Kidney Disease, Hemodialysis Patients, Physical Rehabilitation During Dialysis. Basic parameters: 21 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Kuwait
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Comparative Study of Intradialytic Versus Pre-Dialysis Physical Therapy Interventions in Individuals Undergoing Hemodialysis: A Randomized Controlled Trial
Overview
This randomized controlled trial aims to compare the effectiveness of two different timings of physical therapy for individuals undergoing hemodialysis: intradialytic (during dialysis) and pre-dialysis (before dialysis). The study seeks to determine which approach provides better improvements in physical function, quality of life, and biochemical outcomes such as hemoglobin and electrolyte levels. A total of 72 adult participants with end-stage renal disease (ESRD) receiving hemodialysis will be randomly assigned to one of two groups. Both groups will receive standardized educational sessions on the benefits and safety of exercise before beginning the intervention. Participants in the intradialytic group will perform supervised exercises during their dialysis sessions, while those in the pre-dialysis group will complete similar exercises before their dialysis sessions. Each participant will undergo the intervention twice per week for 12 weeks. Primary outcomes include physical function, assessed using the Six-Minute Walk Test and the Five Times Sit-to-Stand Test. Secondary outcomes include hemoglobin levels, electrolyte balance, and health-related quality of life measured by the KDQOL questionnaire. The study will be conducted at Mubarak Al-Abdullah Al-Jaber Al-Sabah Dialysis Center, Kuwait, following ethical approval from the Ministry of Health Research Ethics Committee. The results are expected to inform best practices for integrating physical therapy into dialysis care to enhance the health, safety, and well-being of individuals undergoing hemodialysis.
Interventions
- Behavioral Physical Therapy Exercise Program
A structured physical therapy program including warm-up, strengthening, balance, and stretching exercises delivered either during or before hemodialysis sessions (twice weekly for 12 weeks).
Primary outcome measures
- Six-Minute Walk Test (6MWT) [Time frame: Baseline, every 4 weeks during the 3-month intervention period, and at 6-month follow-up]
- Quality of Life (Kidney Disease Quality of Life - KDQOL) [Time frame: Baseline, every 4 weeks during the 3-month intervention period, and at 6-month follow-up]
- Five Times Sit-to-Stand Test (FTSST) [Time frame: Baseline, every 4 weeks during the 3-month intervention period, and at 6-month follow-up]
Secondary outcome measures (5)
- Hemoglobin Level [Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks]
- Serum Potassium Level [Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks]
- Serum Sodium Level [Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks]
- Serum Calcium Level [Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks]
- Serum Phosphorus Level [Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks]
Eligibility criteria
Inclusion criteria
- Adults aged between 21 and 65 years.
- Diagnosed with end-stage renal disease (ESRD).
- Undergoing maintenance hemodialysis for at least 3 months.
- Medically stable and cleared by the nephrologist to participate in moderate physical exercise.
- Able to understand and follow verbal instructions and provide informed consent.
Exclusion criteria
- Uncontrolled hypertension, recent myocardial infarction, or unstable angina.
- Severe musculoskeletal, neurological, or cardiovascular disorders that limit physical activity.
- Active infection, fever, or open wounds.
- Recent hospitalization within the past month.
- Participation in any other structured exercise program within the last 3 months.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Kuwait · 1 center
- Mubarak Al-Abdullah Al-Jaber Al-Sabah Dialysis Center — Hawalli
Identifiers
NCT: NCT07361146 · 2024/2681 · IRB-2024-2681