Difference Between Interval and Continous Intradialytic Exercise on Functional Capacity in Hemodialysis Patient

NCT05722496 | Completed DMC

• 1 other identifier: 111118
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to find out the effect of interval versus continous intradialytic training on muscle quality index and functional capacity in Hemodialysis patients. The main question it aims to answer is: Does interval versus continous intradialytic training have an effect on muscle quality index and functional capacity in hemodialysis patients? Patients will be assigned randomly by computerized block randomization into two groups:Group (A): 30 patients will participate in 8 weeks of aerobic exercise in the form of high intensity interval training (HIIT) intradialytic pedaling exercise plus hemodialysis (3 sessions per week).Group (B): 30 patients will participate in 8 weeks of aerobic exercise in the form of moderate intensity continous training (MICT) intradialytic pedaling exercise plus hemodialysis (3 sessions per week) . primary and secondary variables will be measured before starting treatment and after completion (after 2 months )

Conditions

Hemodialysis Complication

Outcome Measures

Primary Outcomes (2)

• muscle quality index

  The MQI was quantified using a timed sit-to-stand test, body mass, and leg length to calculate a power index that is expressed in watts (W). The MQI was calculated as follows: QI (Watts) = ((Leg length×0.4) ×Bodymass×gravity×10) ∕ Time taken for (sit to stand 5 times) Body mass will be measured using a digital scale. Leg length will be taken using tape measure to measure the distance (in meters) from the greater trochanter of the femur to the lateral malleolus, measured from standing position . BY using a stopwatch, sit-to-stand time will be calculated as the time to stand from a seated position and return to sitting consecutively five times. The use of arms not allowed during the sit-to-stand test. Acceleration of gravity (9.8 m/s2). After measuring leg length, body mass and time for sit to stand, all these data will be written in the previous equation to calculate muscle quality index and expressed in watts (W).

  2 months

• six minute walk test

  Six minute walk test (6MWT) to assess physical functional capacity (using stopwatch, colored tape to mark starting line and end line of corridor) Using a stopwatch, assess physical functional capability. The 6MWT will be conducted indoors along a 30 m long, level, straight, enclosed hallway, with the length of the corridor indicated with brightly coloured tape at the beginning and end lines. Subjects will be advised to walk as far as possible from end to end of the corridor without jogging or running, and to cover as much distance as feasible in the 6 minute time limit . This test was performed at the beginning of treatment and at the end of treatment program (8 weeks) to assess functional performance difference.

  2 months

Study Arms (2)

High Intensity Interval Training Group (Group A)

EXPERIMENTAL

Each training session consist of three parts of 30 minutes: * Warm up (5 minutes) free active exercise of the lower extremities, * Training continued with three exercise intervals lasting 3 min each, at an exercise intensity of 85%-95% of HRpeak equalling 15-17 on the Borg scale. Each interval was separated by 4 min of active breaks at an intensity of 60%-70% of HRpeak. * Cool down (5 minutes) free exercise of lower extremities. Training program will last for 8 weeks with frequency 3times / week.

Other: Aerobic pedaling exercise

Moderate intensity continous training group (Group B)

EXPERIMENTAL

Each training session consist of three parts of 30 minutes: * Warm up (5 minutes) free active exercise of the lower extremities, * Training continued with cycling at low-to-moderate exercise intensity of 50%-60% of HRpeak, representing 11-13 on the Borg scale. * Cool down (5 minutes) free exercise of lower extremities. Training program will last for 8 weeks with frequency 3times / week.

Other: Aerobic pedaling exercise

Interventions

Aerobic pedaling exercise OTHER

aerobic exercise in the form of leg pedaling exercise in semi-supine position using leg ergometer by different intensities

High Intensity Interval Training Group (Group A); Moderate intensity continous training group (Group B)

Eligibility Criteria

• Age: 45 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 45- 55 years.
• Male sex included.
• Patients with grade 5 chronic renal failure on hemodialysis.
• Patients are on hemodialysis for 1-3 years.
• Body mass index (BMI) range from 25-34.9 Kg/m2.
• They will be medically and psychologically stable.
• Receiving their physician-prescribed pharmacotherapy regularly.
• Agree to participate by signing an informed consent form.

You may not qualify if:

• Inability to comprehend and follow instructions as in dementia or speech problems such as dysphasia.
• Patients with unstable angina, uncontrolled cardiac arrhythmia, decompensated heart failure, persistent systolic blood pressure (BP) greater than 200 mmHg, persistent diastolic BP greater than 120 mmHg, acute pericarditis or myocarditis.
• Acute systemic infection.
• Presence of malignant disease.
• Patients with Diabetes Mellitus.
• Patients with Lupus Nephritis.
• Patients with chronic obstructive lung disease, restrictive lung disease or chronic chest infection.
• Severe obesity (BMI \> 35).
• Chronic inflammatory orthopedic disorders and rheumatoid arthritis.
• Patients with muscle injuries or neuromuscular disorders (muscular dystrophy, myasthenia gravis, myopathy, multiple sclerosis and peripheral neuropathy).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of physical therapy, cairo university

Cairo, Dokki, 12611, Egypt

Location

Study Officials

• hala m ezz eldeen, professor

  department of cardiovascular, respiratory and geriatrics disorders

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: block randomization and envelopes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer at department of cardiovascular, respiratory and geriatrics

Model Details: Patients will be assigned randomly by computerized block randomization into two groups:Group (A): 30 patients aged between 45 - 55 years old will participate in 8 weeks of aerobic exercise in the form of high intensity interval training (HIIT) intradialytic pedaling exercise plus hemodialysis (3 sessions per week). Group (B): 30 patients aged between 45- 55 years old will participate in 8 weeks of aerobic exercise in the form of moderate intensity continous training (MICT) intradialytic pedaling exercise plus hemodialysis (3 sessions per week).

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: February 10, 2023
• Study Start: January 3, 2023
• Primary Completion: September 10, 2023
• Study Completion: September 10, 2023
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)