Aerobic Versus Resistive Intradialytic Training Effect on Atherogeinc Index in Hemodialysis Patients

NCT ID: NCT07045064

Last Updated: 2025-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-04

Study Completion Date

2026-03-31

Brief Summary

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the goal of the clinical trial is to study the effect of aerobic and resistive exercises on atherogenic index in hemodialysis patients the study will include three groups of both sex the first group will participate in aerobic exercise ,the second group will participate in resistive exercise and the third group will be control group

Detailed Description

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This study will be carried out on sixty male and female patients. They will be recruited from National Institute of Kidney and Urology, Mataria,Their ages will be ranged from (40-60) years old these patients will be assigned into three groups (A, B and C). The design of this study will be a randomized controlled trail (RCT).The patients will be informed about the study procedure and signed the informed consent prepared for this study . The study will follow the instructions of ethical committee of faculty of physical therapy, Cairo University. Inclusive criteria

1. Maintenance hemodialysis ≥ 3 months.
2. BMI will be ranged from 18.5 to 29.9 kg/m².
3. Age ≥ 40years and ≤ 60 years.
4. Hemodialysis 3 times a week.

Exclusive criteria:

1. patients suffered from any central and peripheral nervous system diseases.
2. patients suffered from serious complications, such as heart failure, severe infection and malignant tumor.
3. uncontrolled hypertension with systolic blood pressure ⩾200 mm Hg and/or diastolic blood pressure ⩾120 mm Hg,
4. unstable angina

Conditions

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Chronic Kidney Disease Requiring Hemodialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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arm 1 intervintion : aerobic exercise training without medication

Group A:twenty patients of both sex Iintervention :moderate intensity intradialytic aerobic training for 12 weeks. (3 times per week). Using Horizontal electromagnetically braked cycle ergometer during the first half of the dialysis session.

(1) Frequency: received intradialytic, lower-limb, cycling exercise three times per week on alternative days (2) Intensity: the intensity of exercise will be at 12-14 based on the Borg's Perceived Exertion Rating Scale.(a rating of 6 perceiving "no exertion at all" to 20 perceiving a "maximal exertion" of effort) ,Appropriate speed and grade of resistance were adjusted to achieve the required intensity. (3) Time: each session consisted of a a 5-min warm-up in form of ankle pump exercises, 20-min moderate intensity exercise, and 5-min cool-down phase in form of ankle pump exercise.

Group Type EXPERIMENTAL

Aerobic exercise without medication

Intervention Type OTHER

twenty patients will participate in moderate intensity intradialytic aerobic training for 12 weeks. (3 times per week). Using Horizontal electromagnetically braked cycle ergometer during the first half of the dialysis session.

(1) Frequency: received intradialytic, lower-limb, cycling exercise three times per week on alternative days (2) Intensity: the intensity of exercise will be at 12-14 (moderate-intensity: somewhat hard or reports of feeling a little bit tired but still ok to continue) based on the Borg's Perceived Exertion Rating Scale Appendix III (a rating of 6 perceiving "no exertion at all" to 20 perceiving a "maximal exertion" of effort) ,Appropriate speed and grade of resistance were adjusted to achieve the required intensity. (3) Time: the duration of each exercise session consisted of a 5-min warm-up in form of circulatory exercise.

arm2 intervinsion :resistive exercise training without medication

Grob B Twenty patients of both sex intervention :this group will participate in moderate intensity intradialytic resistive training without medication for 12 weeks . (3 sessions per week) using ankle weights.

During session: The warming up phase for 5-minute in form of ankle pump exercises, then the main exercise phase and then cooling down phase for 5 minutes. in form of ankle pump exercises.

The training protocol consisted of five lower-body resistance exercises using ankle weights 3 days/week, The intensity of the program will be moderate, starting with two sets of each exercise at 60% of each patient's three repetition max (3-RM) strength, progressing to three sets per session, with additional weight added as tolerated.

Group Type EXPERIMENTAL

resistive exercise without medication

Intervention Type OTHER

Twenty patients will participate in moderate intensity intradialytic resistive training for 12 weeks. (3 sessions per week) using ankle weights.

During session: The warming up phase for 5-minute in form of circulatory exercises, then the main exercise phase and then cooling down phase for 5 minutes. in form of circulatory exercises.

The training protocol consisted of five lower-body resistance exercises using ankle weights 3 days/week, The intensity of the program will be moderate, starting with two sets of each exercise at 60% of each patient's three repetition max (3-RM) strength, progressing to three sets per session, with additional weight added as tolerated

arm3 intervention : circulatory exercises training without medication

Group C this group will include 20 patients of both sex intervension : patients will participate in ankle pump exercises and will be evaluated at the beginning and at the end of the study.

Group Type EXPERIMENTAL

circulatory exercise without medication

Intervention Type OTHER

this group will include 20 patients will participate in circulatory exercises and will be evaluated at the beginning and at the end of the study.

Interventions

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Aerobic exercise without medication

twenty patients will participate in moderate intensity intradialytic aerobic training for 12 weeks. (3 times per week). Using Horizontal electromagnetically braked cycle ergometer during the first half of the dialysis session.

(1) Frequency: received intradialytic, lower-limb, cycling exercise three times per week on alternative days (2) Intensity: the intensity of exercise will be at 12-14 (moderate-intensity: somewhat hard or reports of feeling a little bit tired but still ok to continue) based on the Borg's Perceived Exertion Rating Scale Appendix III (a rating of 6 perceiving "no exertion at all" to 20 perceiving a "maximal exertion" of effort) ,Appropriate speed and grade of resistance were adjusted to achieve the required intensity. (3) Time: the duration of each exercise session consisted of a 5-min warm-up in form of circulatory exercise.

Intervention Type OTHER

resistive exercise without medication

Twenty patients will participate in moderate intensity intradialytic resistive training for 12 weeks. (3 sessions per week) using ankle weights.

During session: The warming up phase for 5-minute in form of circulatory exercises, then the main exercise phase and then cooling down phase for 5 minutes. in form of circulatory exercises.

The training protocol consisted of five lower-body resistance exercises using ankle weights 3 days/week, The intensity of the program will be moderate, starting with two sets of each exercise at 60% of each patient's three repetition max (3-RM) strength, progressing to three sets per session, with additional weight added as tolerated

Intervention Type OTHER

circulatory exercise without medication

this group will include 20 patients will participate in circulatory exercises and will be evaluated at the beginning and at the end of the study.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

.Maintenance hemodialysis ≥ 3 months. .BMI will be ranged from 18.5 to 29.9 kg/m². .Age ≥ 40years and ≤ 60 years. .Hemodialysis 3 times a week.

Exclusion Criteria

.patients suffered from any central and peripheral nervous system diseases. .patients suffered from serious complications, such as heart failure, severe infection and malignant tumor.

.uncontrolled hypertension with systolic blood pressure ⩾200 mm Hg and/or diastolic blood pressure ⩾120 mm Hg.

.unstable angina
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Mariam Rezk Asad Rasheed

lecturer assistant at faculty of physical therapy Cairo university

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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nesreen Vice Dean faculty of physical therapy, Professor

Role: STUDY_DIRECTOR

Cairo University

Locations

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National Institute of Kidney and Urology, Mataria

Cairo, Select State, Egypt

Site Status NOT_YET_RECRUITING

National Institute of Kidney and Urology, Mataria

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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mariam rezk rezk, lecturer assistant

Role: CONTACT

01280207863

Facility Contacts

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mariam rezk lecturer assistant at faculty of physical therapy

Role: primary

01280207863

ahmed hassan head of nephrology department NIUN, prof of nephrology and renal p

Role: primary

01020372225

Other Identifiers

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exerciseinhemodialysispatients

Identifier Type: -

Identifier Source: org_study_id

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