Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:20 AM
Study NCT ID:
NCT07319468
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-06
First Post:
2025-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Exercises on Hemodialysis
Sponsor:
Cairo University
Organization:
Study Overview
Official Title:
Effect of Intra Dialytic Aerobic Exercises Versus Active Free Exercises on Cognitive Function and Functional Capacity in Hemodialytic Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: