NCT07076888

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™)

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 22, 2025

Completed
10 days until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2025

Completed
Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

4 months

First QC Date

June 10, 2025

Last Update Submit

November 15, 2025

Conditions

Keywords

Aerobic exercisehemodialysisserum uric acidquality of life

Outcome Measures

Primary Outcomes (1)

  • Serum Uric Acid

    from enrollment to the end of 6 weeks of treatment

Secondary Outcomes (2)

  • Change in Functional ability of the patient

    from enrollment to the end of 6 weeks of treatment

  • Change in Quality of life

    from enrollment to the end of 6 weeks of treatment

Study Arms (2)

Group A

EXPERIMENTAL

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.

Other: Aerobic ExercisesOther: Conventional Program

Group B

ACTIVE COMPARATOR

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

Other: Conventional Program

Interventions

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

Group A

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 AGroup B

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Hemodialysis patients aged 40-60years
  • Patients are medically stable and able to participate in physical activity.
  • Participants are able to understand the commands.
  • Participants must be stable on hemodialysis for at least 3 months.

You may not qualify if:

  • Patients with significant cardiovascular or respiratory diseases, or other conditions that could impair their ability to exercise.
  • Severe cognitive impairment or psychiatric conditions that could interfere with study participation.
  • patients with acute medical conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physical Therapy faculty, Cairo University

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Heba Elfeky Lecturer of physical therapy - Cairo University, lecturer

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

    STUDY DIRECTOR

Central Study Contacts

Doaa Rafat Assistant professor of physical therapy - Cairo university

CONTACT

Mahetab Gamal Ali

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Physical Therapy, Faculty of Physical Therapy, Cairo University

Study Record Dates

First Submitted

June 10, 2025

First Posted

July 22, 2025

Study Start

August 1, 2025

Primary Completion

December 1, 2025

Study Completion

December 20, 2025

Last Updated

November 19, 2025

Record last verified: 2025-11

Locations