Effect of Exercises on Hemodialysis

Effect of Intra Dialytic Aerobic Exercises Versus Active Free Exercises on Cognitive Function and Functional Capacity in Hemodialytic Patients

o Sixty-nine adult patients from both sexes. They were suffering from ESRD on maintenance hemodialysis, their age ranged from50-60 years old were selected from hemodialysis unit at Itay El Baroud central hospital. They were referred by the physician.

Study Overview

• Status: Not yet recruiting
• Conditions: Hemodialytic Patients
• Intervention / Treatment: Device: Aerobic exercises; Other: Open kinetic chain active free range of motion; Other: No intervention

Detailed Description

Ⅰ-Subjects:

o Sixty-nine adult patients from both sexes. They were suffering from ESRD on maintenance hemodialysis, their age ranged from50-60 years old were selected from hemodialysis unit at Itay El Baroud central hospital. They were referred by the physician.

Study group (A): the study group consisted of (23) patients who received aerobic exercise in form of (foot pedal exerciser) for 20 Minutes for each session, 3 sessions per week, for 8 weeks plus maintain on their medical treatment and hemodialysis.

Study group (B): the study group consisted of (23) who received active free range of motion exercise (open kinetic chain active free range of motion) for 20 minutes for each session, 3 sessions per week, for 8 weeks plus maintain on their medical treatment and hemodialysis.

Control group (C): the control group consisted of (23) patients who were maintained on their medical treatment and hemodialysis.

II- Instrumentation 6-Minutes walk test: The 6-min walk test (6MWT) is frequently used to measure physical function in transplanted patients.

• Fatigue Questionnaire (Fatigue Severity Scale) it was used to assess the level of fatigue.
• Laboratory investigation: urea and creatinine are commonly used to monitor the effects of exercise on urea clearance and kidney function improvement in transplant patients.
• The Mini-Cog test: is a quick, simple, and effective screening tool for early cognitive impairment in hemodialysis patients, making it ideal for busy clinical settings.

B-Therapeutic Equipment:

Foot pedal exerciser (fig.9):

• Simple horizontal foot pedal exerciser used during hemodialysis sessions.
• Dual pedals with non-slip straps for foot stability.
• Manual resistance adjustment via a single control knob (non-electric).
• Provides gradual increase in workload intensity.
• Compact and light weight design suitable for use while lying on the dialysis bed.
• Enables controlled, low-impact circular movement of the feet.
• Aims to improve circulation and strengthen lower limb muscles without requiring active sitting.
• Approximate device dimensions: 50 cm (length) x 40 cm (width) x 23 cm (height).
• Maximum recommended user weight: 70 kg. Participants completed the 30-min aerobic exercise sessions during the first 2 hrs. of each dialysis session, 3 times per week for 8 weeks, using a simulated bike riding. Patients will perform active free exercise for upper limb (the arm that hasn't shunt) and lower limbs. Each exercise session consisted of three phases: warm up, conditioning, and cool down.

• Study Type: Interventional
• Enrollment (Estimated): 69
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Faten Mahmoud Eldesouky, Master in Physical Therapy; Phone Number: 01002618702 01002618702; Email: fateneldesouky546@gmail.com
• Study Contact Backup: Name: Research Ethical Committee, Principal Investigator; Phone Number: 01151312322; Email: eth.com@pt.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

All patients were included according to the following criteria:

1. Age between 50-60years.
2. The patients had been on hemodialysis for at least 3 months with three sessions per week for 3-4hr per session.
3. The patients were diagnosed with end stage renal failure (stage5 CKD) on maintenance regular HD (three sessions/week (on alternate days), for four hours/session) for more than three months. (Receiving HD through uncomplicated arm arteriovenous (A-V) fistula
4. Under medical control
5. Both men and women were enrolled
6. Body math index ranged from 18,5- 24.9 kg/m²

Exclusion Criteria:

Patients who experienced or had one or more of the following were excluded from the study:

1. Patients with resting systolic blood pressure >200 mmHg and/or diastolic blood pressure >120 mmHg.
2. patients with neurological problems (e.g. stroke, head injury)
3. patients with musculoskeletal problems (e.g. sever osteoarthritis or difficulties in ambulation)
4. Patients with uncontrolled pulmonary disease. (e.g. exaggerated chronic obstructive pulmonary disease, acute asthma)
5. Patients with mental health problems and cognitive impairment due to inability to teach them how to make respiratory training.
6. Any patient who missed more than two weeks of the program or want to terminate the program.
7. Severe obesity (BMI >35)
8. Presence of malignant disease.
9. Patients with unstable angina, uncontrolled cardiac arrhythmia, decompensated heart failure, acute pericarditis or myocarditis.
10. The patients had hearing impairment or mental disorders.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aerobic exercise; (23) patients who received aerobic exercise in form of (foot pedal exerciser) for 20 Minutes for each session, 3 sessions per week, for 8 weeks.	Device: Aerobic exercises; Foot pedal exerciser: Simple horizontal foot pedal exerciser used during hemodialysis sessions.; Dual pedals with non-slip straps for foot stability.; Manual resistance adjustment via a single control knob (non-electric).; Provides gradual increase in workload intensity.; Compact and light weight design suitable for use while lying on the dialysis bed.; Enables controlled, low-impact circular movement of the feet.; Aims to improve circulation and strengthen lower limb muscles without requiring active sitting.; Approximate device dimensions: 50 cm (length) x 40 cm (width) x 23 cm (height).; Maximum recommended user weight: 70 kg.
Experimental: Active free range of motion exercise; (23) patients who received active free range of motion exercise (open kinetic chain active free range of motion) for 20 minutes for each session, 3 sessions per week, for 8 weeks.	Other: Open kinetic chain active free range of motion; Participants completed the 30-min aerobic exercise sessions during the first 2 hrs. of each dialysis session, 3 times per week for 8 weeks, using a simulated bike riding. Patients will perform active free exercise for upper limb (the arm that hasn't shunt) and lower limbs. Each exercise session consisted of three phases: warm up, conditioning, and cool down.
Other: control group; (23) patients who will receive standard medical treatment for end-stage renal disease, including regular hemodialysis sessions and pharmacological management (e.g., Epoetin alfa and phosphate binders) as prescribed by their nephrologist, without participating in the physical therapy exercise program.	Other: No intervention; the control group will receive only the standard medical care provided by dialysis center without any physical therapy intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue Questionnaire (Fatigue Severity Scale)	The Fatigue Severity Scale it used to assess the level of fatigue. The Fatigue Severity Scale scores range from 9 to 36 where higher scores indicate worse fatigue and lower scores indicate improvement in fatigue.	8 weeks
6-Minutes walk test	The 6-min walk test (6MWT) is frequently used to measure physical function in transplanted patients	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Laboratory investigation (Urea analysis)	Urea analysis is commonly used to monitor the effects of exercise on urea clearance and kidney function	8 weeks
The Mini-Cog test	The Mini-Cog test is a quick, simple, and effective screening tool for early cognitive impairment in hemodialysis patients, making it ideal for busy clinical settings. The Mini-Cog Test scores range from 0 to 5, where higher scores indicate better cognitive performance, and lower scores suggest potential cognitive impairment.	8 weeks
Laboratory investigation (creatinine analysis)	creatinine analysis is used to be monitor the effects of exercise on creatinine clearance and kidney function	8 weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Research Ethical Committee Cairo University, Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: December 9, 2025
• First Submitted That Met QC Criteria: December 20, 2025
• First Posted (Actual): January 6, 2026

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 20, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Aerobic Exercise; Chronic kidney disease; Hemodialysis; Functional Capacity
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic
• Other Study ID Numbers: NO:P.T.R.EC/012/004902

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No