NCT07045064

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 1, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

July 4, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

July 9, 2025

Status Verified

February 1, 2025

Enrollment Period

6 months

First QC Date

June 22, 2025

Last Update Submit

July 3, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • atherogenic index

    aterogenic index will be measured through blood test ,an AIP value of under 0.11 is associated with low risk of CVD; the values between 0.11 to 0.21 and upper than 0.21 are associated with intermediate and increased risks, respectively

    three months

Study Arms (3)

arm 1 intervintion : aerobic exercise training without medication

EXPERIMENTAL

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.

Other: Aerobic exercise without medication

arm2 intervinsion :resistive exercise training without medication

EXPERIMENTAL

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.

Other: resistive exercise without medication

arm3 intervention : circulatory exercises training without medication

EXPERIMENTAL

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.

Other: circulatory exercise without medication

Interventions

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.

arm 1 intervintion : aerobic exercise training 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

arm2 intervinsion :resistive exercise training 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.

arm3 intervention : circulatory exercises training without medication

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Institute of Kidney and Urology, Mataria

Cairo, Select State, Egypt

NOT YET RECRUITING

National Institute of Kidney and Urology, Mataria

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

ExerciseDosage Forms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaPharmaceutical PreparationsTechnology, PharmaceuticalInvestigative Techniques

Study Officials

  • nesreen Vice Dean faculty of physical therapy, Professor

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

mariam rezk rezk, lecturer assistant

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer assistant at faculty of physical therapy Cairo university

Study Record Dates

First Submitted

June 22, 2025

First Posted

July 1, 2025

Study Start

July 4, 2025

Primary Completion

January 1, 2026

Study Completion

March 1, 2026

Last Updated

July 9, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations