Effect of Exercises on Hemodialysis

NCT07319468 | Not Yet Recruiting

• 1 other identifier: NO:P.T.R.EC/012/004902
• Study Type: interventional
• Target: 69
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hemodialytic Patients

Keywords

Aerobic Exercise; Chronic kidney disease; Hemodialysis; Functional Capacity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Laboratory investigation (Urea analysis)

  8 weeks

• The Mini-Cog test

  8 weeks

• Laboratory investigation (creatinine analysis)

  8 weeks

Study Arms (3)

Aerobic exercise

EXPERIMENTAL

(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

Active free range of motion exercise

EXPERIMENTAL

(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

control group

OTHER

(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

Interventions

Aerobic exercises 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.

Aerobic exercise

Open kinetic chain active free range of motion 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.

Active free range of motion exercise

No intervention OTHER

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

control group

Eligibility Criteria

• Age: 50 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• All patients were included according to the following criteria:
• Age between 50-60years.
• The patients had been on hemodialysis for at least 3 months with three sessions per week for 3-4hr per session.
• 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
• Under medical control
• Both men and women were enrolled
• Body math index ranged from 18,5- 24.9 kg/m²

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Research Ethical Committee Cairo University

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Faten Mahmoud Eldesouky, Master in Physical Therapy

CONTACT

01002618702; [email protected]

Research Ethical Committee, Principal Investigator

CONTACT

01151312322; [email protected]

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant of Physical Therapy, Chest Hospital, Damanhour, Elbeheira

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: January 6, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 6, 2026

Record last verified: 2025-12