Aerobic Exercises and Hemodialysis Patients

NCT ID: NCT07076888

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2025-12-20

Brief Summary

Patients undergoing hemodialysis (HD) frequently exhibit elevated serum uric acid (SUA) levels, which are associated with cardiovascular risks, joint issues, and diminished quality of life (QoL). Aerobic exercise has been shown to improve cardiovascular health and reduce SUA levels in various populations, suggesting potential benefits for HD patients.

Objective: This study aimed to investigate the impact of aerobic exercise on serum uric acid (SUA) levels, functional capacity, and quality of life (QoL) in patients undergoing hemodialysis (HD).

Methods: This randomized controlled trial will recruit 32 participants, aged 40-60, undergoing HD. The intervention group (Group A) will participate in a structured 6-week aerobic exercise program, while the control group (Group B) will receive only conventional physical therapy. Pre- and post-intervention assessments included SUA levels, the Six-Minute Walk Test (6MWT), and the Kidney Disease Quality of Life Short Form (KDQOL-SF™)

Detailed Description

32 Subjects of both genders will participate in this study at El-khazendara Hospitals with age ranged between (40-60) years old. They will receive a comprehensive verbal and written explanation of the study, including its objectives, procedures, and potential benefits.

participants will randomly assigned into two equal groups using a sealed-envelope randomization method to ensure unbiased allocation.

• Group A (study Group): 16 HD patients receiving a conventional physical therapy program (breathing, stretching, and lower limb circulatory exercises) plus the aerobic exercise program.
• Group B (Control Group): 16 HD patients receiving only the conventional physical therapy program.

6-weeks of aerobic exercise program (3 sessions per week, 20-45 minutes each session)

Outcome measures include:

• Serum Uric Acid: Measured using an automated biochemistry analyzer, with results reported in mg/dL.
• Functional Capacity: Assessed using the Six-Minute Walk Test (6MWT), a validated tool used to evaluate exercise tolerance and endurance in clinical populations.
• Quality of Life:Measured using the Kidney Disease Quality of Life Short Form (KDQOL-SF™) Arabic Version, which assesses various domains related to both physical and mental health.

Conditions

Hemodialysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A

Group A (study Group): 16 HD patients received a conventional physical therapy program (breathing, stretching, and lower limb circulatory exercises) combined with the aerobic exercise program.

Group Type: EXPERIMENTAL

Aerobic Exercises

Intervention Type: OTHER

1. Timing of Exercise:

Aerobic exercises were performed on non-dialysis days. This scheduling avoids post-dialysis fatigue and hypotensive effects, optimizing patient safety and performance.

2. Frequency:

Patients was engaged in aerobic exercise 3 times per week on non-consecutive days, to allow sufficient recovery time between sessions.

3. Duration of Each Session:

• Total Duration: Each exercise session was last between 20 to 45 minutes.
• Warm-Up: 5-10 minutes of low-intensity activity (e.g., slow walking).
• Main Exercise: 15-30 minutes of moderate-intensity aerobic exercise.
• Cool-Down:*5-10 minutes of gradual reduction in intensity.

4. Exercise Modality:

• Options: Patients may choose between treadmill walking or using a stationary bike, depending on their preference, physical condition.
• Variety: To maintain engagement and reduce monotony, patients can alternate between treadmill and bike exercises.

5. Intensity:

Use moderate-intensity exercise, aiming for 60-70% of the p

Conventional Program

Intervention Type: OTHER

1. Breathing Exercises

• Diaphragmatic Breathing: Instruct patients to place one hand on their chest and the other on their abdomen. They should inhale deeply through their nose, allowing the abdomen to rise, and then exhale slowly through their mouth. This breathing technique has been shown to reduce stress, improve respiratory efficiency, and enhance relaxation . For optimal benefits, patients should practice this for 5-10 minutes, 2-3 times a day.

Stretching Exercises Hamstring Stretch: Instruct patients to sit with one leg extended straight out in front of them and the other leg bent. They should reach towards the toes of the extended leg while keeping their back straight. Hold the stretch for 20-30 seconds and repeat the stretch 2-3 times per leg.

Lower Limb Circulatory Exercises Ankle Pumps: While lying down or seated, instruct patients to alternately point and flex their feet to stimulate circulation and improve lower leg mobility. Perform 20-30 pumps per foot, 2-3 times a day

Group B

Group B (Control Group): 16 HD patients received only the conventional physical therapy program.

Group Type: ACTIVE_COMPARATOR

Conventional Program

Intervention Type: OTHER

1. Breathing Exercises

• Diaphragmatic Breathing: Instruct patients to place one hand on their chest and the other on their abdomen. They should inhale deeply through their nose, allowing the abdomen to rise, and then exhale slowly through their mouth. This breathing technique has been shown to reduce stress, improve respiratory efficiency, and enhance relaxation . For optimal benefits, patients should practice this for 5-10 minutes, 2-3 times a day.

Stretching Exercises Hamstring Stretch: Instruct patients to sit with one leg extended straight out in front of them and the other leg bent. They should reach towards the toes of the extended leg while keeping their back straight. Hold the stretch for 20-30 seconds and repeat the stretch 2-3 times per leg.

Lower Limb Circulatory Exercises Ankle Pumps: While lying down or seated, instruct patients to alternately point and flex their feet to stimulate circulation and improve lower leg mobility. Perform 20-30 pumps per foot, 2-3 times a day

Interventions

Aerobic Exercises

1. Timing of Exercise:

Aerobic exercises were performed on non-dialysis days. This scheduling avoids post-dialysis fatigue and hypotensive effects, optimizing patient safety and performance.

2. Frequency:

Patients was engaged in aerobic exercise 3 times per week on non-consecutive days, to allow sufficient recovery time between sessions.

3. Duration of Each Session:

• Total Duration: Each exercise session was last between 20 to 45 minutes.
• Warm-Up: 5-10 minutes of low-intensity activity (e.g., slow walking).
• Main Exercise: 15-30 minutes of moderate-intensity aerobic exercise.
• Cool-Down:*5-10 minutes of gradual reduction in intensity.

4. Exercise Modality:

• Options: Patients may choose between treadmill walking or using a stationary bike, depending on their preference, physical condition.
• Variety: To maintain engagement and reduce monotony, patients can alternate between treadmill and bike exercises.

5. Intensity:

Use moderate-intensity exercise, aiming for 60-70% of the p

Intervention Type: OTHER

Conventional Program

1. Breathing Exercises

• Diaphragmatic Breathing: Instruct patients to place one hand on their chest and the other on their abdomen. They should inhale deeply through their nose, allowing the abdomen to rise, and then exhale slowly through their mouth. This breathing technique has been shown to reduce stress, improve respiratory efficiency, and enhance relaxation . For optimal benefits, patients should practice this for 5-10 minutes, 2-3 times a day.

Stretching Exercises Hamstring Stretch: Instruct patients to sit with one leg extended straight out in front of them and the other leg bent. They should reach towards the toes of the extended leg while keeping their back straight. Hold the stretch for 20-30 seconds and repeat the stretch 2-3 times per leg.

Lower Limb Circulatory Exercises Ankle Pumps: While lying down or seated, instruct patients to alternately point and flex their feet to stimulate circulation and improve lower leg mobility. Perform 20-30 pumps per foot, 2-3 times a day

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Hemodialysis patients aged 40-60years

2. Patients are medically stable and able to participate in physical activity.

3. Participants are able to understand the commands.

4. Participants must be stable on hemodialysis for at least 3 months.

Exclusion Criteria

1. Patients with significant cardiovascular or respiratory diseases, or other conditions that could impair their ability to exercise.

2. Severe cognitive impairment or psychiatric conditions that could interfere with study participation.

3. patients with acute medical conditions.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Doaa Rafat

Assistant Professor of Physical Therapy, Faculty of Physical Therapy, Cairo University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heba Elfeky Lecturer of physical therapy - Cairo University, lecturer

Role: STUDY_DIRECTOR

Department of Basic sciences for physical therapy, Faculty of Physical Therapy , Cairo university, Cairo, Egypt

Locations

Physical Therapy faculty, Cairo University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Doaa Rafat Assistant professor of physical therapy - Cairo university

Role: CONTACT

doaa.rafat@pt.cu.edu.eg

201005591580

Mahetab Gamal Ali

Role: CONTACT

Mahetab.gamal@gmail.com

201009502621

Facility Contacts

Doaa Assistant professor of physical therapy, Assistant professor

Role: primary

doaa.rafat@pt.cu.edu.eg

00201005591580

Other Identifiers

P.T.REC/025/00123

Identifier Type: -

Identifier Source: org_study_id