Two Different Renal Rehabilitation Protocols in Hemodialysis Patients

NCT06838299 | Completed

• 1 other identifier: hemodialysis
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial will investigate how two different intradialytic exercise programs affect health in older adults with chronic kidney disease receiving regular hemodialysis. One group will perform aerobic exercise (cycling) combined with inspiratory muscle training, another group will perform resistance (strength) exercises combined with inspiratory muscle training, and a third control group will receive standard medical care without structured exercise. Men and women over 60 years of age on regular hemodialysis will be recruited from the kidney dialysis department and will exercise three times per week for three months.

Conditions

Hemodialysis

Outcome Measures

Primary Outcomes (2)

• 6minute walk test

  -6 minute walk test : to detect functional capacity , carry out in a 30 meters line along the passage way , the tape is placed every 2 meter . patients are instructed to walk the longest possible distance in 6 minutes continuously and turning around at the final mark without stopping .they are instructed to walk as far as they can for 6 minutes without running or jogging .covered distance in meters is measured at the end of analysis.

  Outcome will be assessed at baseline (start of the study), at 3 months (immediately after completion of the intervention), and at 6 months (3-month follow-up after the intervention)

• Maximum inspiratory pressure

  -Maximum inspiratory pressure : to determine the inspiratory muscle strength before and after training. the patient will be instructed to insert the mouthpiece into the mouth, ensuring the flange is positioned over the gums and inside the lips, while the 'bite blocks' are between the teeth. The subject should then exhale to RV (Residual Volume), then perform a forced inhalation against the mouthpiece with as much effort as possible for as long as possible (minimum 2 seconds). while the participants were seated in a reclining chair (with knees and hips at 90) in a HD room at the beginning of the HD session .

  Outcome will be assessed at baseline (start of the study), at 3 months (immediately after completion of the intervention), and at 6 months (3-month follow-up after the intervention)

Secondary Outcomes (6)

• Kidney Disease & Quality of Life (KDQOL-SF36)

  Outcome will be assessed at baseline (start of the study), at 3 months (immediately after completion of the intervention), and at 6 months (3-month follow-up after the intervention)

• peak vo2

  Outcome will be assessed at baseline (start of the study), at 3 months (immediately after completion of the intervention), and at 6 months (3-month follow-up after the intervention)

• modified Borg scale

  Outcome will be assessed at baseline (start of the study), at 3 months (immediately after completion of the intervention), and at 6 months (3-month follow-up after the intervention)

• creatinine

  Outcome will be assessed at baseline (start of the study), at 3 months (immediately after completion of the intervention), and at 6 months (3-month follow-up after the intervention)

• GFR

  Outcome will be assessed at baseline (start of the study), at 3 months (immediately after completion of the intervention), and at 6 months (3-month follow-up after the intervention)

Study Arms (3)

Aerobic exercise plus inspiratory muscle training (group A)

ACTIVE COMPARATOR

I)inspiratory muscle training: Inspiratory muscle training at 60% of maximal inspiratory pressure for 30 minutes/ session, 3 days a week, for 3 months Each patient breathes through a separate mouthpiece. The resistance is adjusted at 60% of maximum inspiratory pressure detected from maximum inspiratory pressure meter and is marked on the training device. A single training session consists of five sets, each contains five inspirations with total of twenty five breaths with one minute of recovery between each set. The resistance was adjusted every week to be 60% of the new maximum inspiratory pressure and if it remained the same, the subject continued to train at the level of the previous week Aerobic exercise: 5-minute warm-up before exercise and a 5-minute cool-down following exercise at intensity (40-65%HR reserve) were carried out each time. In addition, the exercise was performed in the first half of the dialysis session over a 3 months period for 3 sessions per week .

Device: aerobic exercise; Other: standard medical treatment; Device: inspiratory muscle training

Resistance exercise plus inspiratory muscle training (group B)

ACTIVE COMPARATOR

Resistance exercise: Dynamic closed- and open-chain resistance exercises performed by the patients quadriceps and hamstrings muscles . Patients started at 50% of their initial one-repetition maximum (1-RM) with 5 repetitions for each exercise and later progressed to three sets of 8 repetitions at 70% of their 1-RM according to the patient Borg scale of exertion; training loads were increased when patients could comfortably complete three sets with good form. inspiratory muscle training: Inspiratory muscle training at 60% of maximal inspiratory pressure for 30 minutes/ session, 3 days a week, for 3 months Each patient breathes through a separate mouthpiece. The resistance is adjusted at 60% of maximum inspiratory pressure detected from maximum inspiratory pressure meter and is marked on the training device. A single training session consists of five sets, each contains five inspirations with total of twenty five breaths with one minute of recovery between each set.

Device: resistance exercise; Other: standard medical treatment; Device: inspiratory muscle training

group C (control group)

ACTIVE COMPARATOR

in this group there is no exercise ,patients have assessment pre and post 3 months and follow up

Other: standard medical treatment

Interventions

aerobic exercise DEVICE

Aerobic exercise: by bicycle ergomete 5-minute warm-up before exercise and a 5-minute cool-down following exercise at intensity (40-65%HR max) were carried out each time. In addition, the exercise was performed in the first half of the dialysis session over a 3 months period for 3 sessions a week

Aerobic exercise plus inspiratory muscle training (group A)

resistance exercise DEVICE

Dynamic closed- and open-chain resistance exercises performed by the patients' quadriceps and hamstring muscles. Patients started at 50% of their initial one-repetition maximum (1-RM) with 5 repetitions for each exercise and later progressed to three sets of 8 repetitions at 70% of their 1-RM according to the patient's Borg scale of exertion; training loads were increased when patients could comfortably complete three sets with good form.

Resistance exercise plus inspiratory muscle training (group B)

standard medical treatment OTHER

standard medical treatment

Aerobic exercise plus inspiratory muscle training (group A); Resistance exercise plus inspiratory muscle training (group B); group C (control group)

inspiratory muscle training DEVICE

Inspiratory muscle training at 60% of maximal inspiratory pressure for 30 minutes/session, 3 days a week, for 3 months Each patient breathes through a separate mouthpiece. The resistance is adjusted at 60% of the maximum inspiratory pressure detected from the maximum inspiratory pressure meter and is marked on the training device. A single training session consists of five sets, each containing five inspirations, with a total of twenty-five breaths with one minute of recovery between each set. The resistance was adjusted every week to be 60% of the new maximum inspiratory pressure and if it remained the same, the subject continued to train at the level of the previous week.

Aerobic exercise plus inspiratory muscle training (group A); Resistance exercise plus inspiratory muscle training (group B)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients from both gender
• With chronic kidney disease
• Unemployed living a sedentary lifestyle
• Receive regular hemodialysis sessions at 3months ago
• All of them have vascular access through arteriovenous fistula
• Age range over 60years
• Fully understand purpose and procedure of study
• Stable and have sufficient level of cognition and ability to understand instructions

You may not qualify if:

• Real difficulties with understanding and signing The written informed consent
• Recent sequela of cerebrovascular accidents
• Osteoarticular or musculoskeletal diseases
• Un controlled systemic hypertension
• Un controlled diabetes
• Un stable angina
• Fever
• Infectious disease
• Acute respiratory failure
• Recent acute myocardial infarction
• Smoking
• Peripheral vascular alterations

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni_suef university

Banī Suwayf, Egypt

Location

Related Publications (1)

• Rhee et al,2019

  RESULT

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Sherine H Mehani, professor

  Beni-Suef University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physiotherapist

Study Record Dates

• First Submitted: February 16, 2025
• First Posted: February 20, 2025
• Study Start: February 28, 2025
• Primary Completion: May 28, 2025
• Study Completion: August 28, 2025
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)