Effect of Exercises on Hemodialysis

NCT ID: NCT07319468

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2026-06-01

Brief Summary

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.

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.

Conditions

Hemodialytic Patients

Study Design

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

Study Groups

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.

Group Type: EXPERIMENTAL

Aerobic exercises

Intervention Type: DEVICE

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.

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.

Group Type: EXPERIMENTAL

Open kinetic chain active free range of motion

Intervention Type: OTHER

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.

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.

Group Type: OTHER

No intervention

Intervention Type: OTHER

the control group will receive only the standard medical care provided by dialysis center without any physical therapy intervention

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

No intervention

the control group will receive only the standard medical care provided by dialysis center without any physical therapy intervention

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Faten Mahmoud

Consultant of Physical Therapy, Chest Hospital, Damanhour, Elbeheira

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Research Ethical Committee Cairo University

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Central Contacts

Faten Mahmoud Eldesouky, Master in Physical Therapy

Role: CONTACT

fateneldesouky546@gmail.com

01002618702 ext. 01002618702

Research Ethical Committee, Principal Investigator

Role: CONTACT

eth.com@pt.cu.edu.eg

01151312322

Other Identifiers

NO:P.T.R.EC/012/004902

Identifier Type: -

Identifier Source: org_study_id