About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Physical Therapy Exercise Program
BehavioralA structured physical therapy program including warm-up, strengthening, balance, and stretching exercises delivered either during or before hemodialysis sessions (twice weekly for 12 weeks).
Treatment groups
Trial outcomes
Primary outcomes
Six-Minute Walk Test (6MWT)
Assessment of functional exercise capacity by measuring the total distance walked in six minutes.
Quality of Life (Kidney Disease Quality of Life - KDQOL)
Quality of life assessed using the Kidney Disease Quality of Life (KDQOL) questionnaire.
Five Times Sit-to-Stand Test (FTSST)
Assessment of lower limb strength and functional mobility by measuring the time required to complete five sit-to-stand repetitions.
Secondary outcomes
Hemoglobin Level
Measurement of hemoglobin concentration from blood samples.
Serum Potassium Level
Measurement of serum potassium concentration.
Serum Sodium Level
Measurement of serum sodium concentration obtained from routine blood samples.
Serum Calcium Level
Measurement of serum calcium concentration obtained from routine blood samples.
Sponsors and contacts
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Mohammad Arian
Lead sponsor
Ministry of Health, Kuwait
Sponsor institution