Effect of Exercises on Hemodialysis

Official title

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

Overview

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.

Interventions

• 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 re
• 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 No intervention
  the control group will receive only the standard medical care provided by dialysis center without any physical therapy intervention

Primary outcome measures

• Fatigue Questionnaire (Fatigue Severity Scale) [Time frame: 8 weeks]
• 6-Minutes walk test [Time frame: 8 weeks]

Secondary outcome measures (3)

• Laboratory investigation (Urea analysis) [Time frame: 8 weeks]
• The Mini-Cog test [Time frame: 8 weeks]
• Laboratory investigation (creatinine analysis) [Time frame: 8 weeks]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07319468 · NO:P.T.R.EC/012/004902

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗