A Comparative Study of Intradialytic vs. Pre-Dialysis Physical Therapy Interventions in Individuals Undergoing Hemodialysis: A Randomized Controlled Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-65
SponsorMohammad Arian

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Physical Therapy Exercise Program

    Behavioral

    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).

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: Intradialytic Physical Therapy (During Dialysis)Experimental treatment 1 intervention
Group B: Pre-Dialysis Physical Therapy (Before Dialysis)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Six-Minute Walk Test (6MWT)

Assessment of functional exercise capacity by measuring the total distance walked in six minutes.

Time frame
Baseline, every 4 weeks during the 3-month intervention period, and at 6-month follow-up
2

Quality of Life (Kidney Disease Quality of Life - KDQOL)

Quality of life assessed using the Kidney Disease Quality of Life (KDQOL) questionnaire.

Time frame
Baseline, every 4 weeks during the 3-month intervention period, and at 6-month follow-up
3

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.

Time frame
Baseline, every 4 weeks during the 3-month intervention period, and at 6-month follow-up

Secondary outcomes

1

Hemoglobin Level

Measurement of hemoglobin concentration from blood samples.

Time frame
Baseline, 4 weeks, 8 weeks, and 12 weeks
2

Serum Potassium Level

Measurement of serum potassium concentration.

Time frame
Baseline, 4 weeks, 8 weeks, and 12 weeks
3

Serum Sodium Level

Measurement of serum sodium concentration obtained from routine blood samples.

Time frame
Baseline, 4 weeks, 8 weeks, and 12 weeks
4

Serum Calcium Level

Measurement of serum calcium concentration obtained from routine blood samples.

Time frame
Baseline, 4 weeks, 8 weeks, and 12 weeks

Other outcomes

Sponsors and contacts

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Mohammad Arian

Lead sponsor

Ministry of Health, Kuwait

Sponsor institution