NCT04522115

Brief Summary

PURPOSE: To compare between the effect of aerobic exercise and resistance exercises on patients with obese chronic kidney diseases. BACKGROUND: excessive adiposity is well recognized as an amplifier for the risk of renal disease progression in patients with chronic kidney diseases of various aetiology. Renal alterations induced by obesity include hyperfiltration, pathological proteinuria/ albuminuria and reduced glomerular filtration rate HYPOTHESES: There will not significantly effect of neither aerobic nor resistance on obesity, in patient with chronic kidney disease. RESEARCH QUESTION: Aerobic exercise and resistance exercise which of them has significant effect on obesity in patient with chronic kidney disease?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 5, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2020

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 21, 2020

Completed
Last Updated

August 25, 2020

Status Verified

August 1, 2020

Enrollment Period

5 months

First QC Date

August 12, 2020

Last Update Submit

August 24, 2020

Conditions

Keywords

chronic kidney failureobesityexercises

Outcome Measures

Primary Outcomes (1)

  • Body mass index

    The weight by kilogram divided by height in square meters.

    12 week

Study Arms (2)

aerobic training

EXPERIMENTAL

Each exercise training session included 3 to 5 minutes of warm-up, range-of-motion exercises, interval training(aerobic training), cool-down, and post-exercise range-of-motion exercises. Patients exercise at 40 to 60% of maximum heart rate.

Other: exercises

Resistance training

EXPERIMENTAL

Resistance exercise training of the lower extremities was performed three times per week. Starting weights for knee extension and hip abduction and flexion were determined from a three-repetition maximum (3RM) using ankle weights that can be adjusted in 1 lb. increments. A 3RM is the maximum weight that can be lifted three times with proper technique. Training started at approximately 60% of 3RM for two sets of 10 repetitions and was increased to three sets as tolerated.

Other: exercises

Interventions

Group(1) aerobic training: Each exercise training session included 3 to 5 minutes of warm-up, range-of-motion exercises, interval training(aerobic training), cool-down, and post-exercise range-of-motion exercises. Patients exercise at 40 to 60% of maximum heart rate. Group(2) resistance exercise: training of the lower extremities was performed three times per week. Starting weights for knee extension and hip abduction and flexion were determined from a three-repetition maximum (3RM) using ankle weights that can be adjusted in 1 lb. increments. A 3RM is the maximum weight that can be lifted three times with proper technique. Training started at approximately 60% of 3RM for two sets of 10 repetitions and was increased to three sets as tolerated.

Also known as: resistance exercises
Resistance trainingaerobic training

Eligibility Criteria

Age35 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Chronic kidney disease Stages 2-4
  • body mass index ≥30
  • Diabetes mellitus

You may not qualify if:

  • Uncontrolled hypertension
  • Uncontrolled diabetes mellitus.
  • Cardiac failure
  • Motor disorders
  • Dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, 12613, Egypt

Location

MeSH Terms

Conditions

Kidney Failure, ChronicObesityMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Manal K Youssef, phD

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: group 1 received aerobic exercises and group 2 received resistance exercises.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

August 12, 2020

First Posted

August 21, 2020

Study Start

January 5, 2020

Primary Completion

May 20, 2020

Study Completion

June 3, 2020

Last Updated

August 25, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations