- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04522115
Exercise for Chronic Kidney Diseases
Effect of Exercise in Obese Patients With Chronic Kidney Diseases
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?
Study Overview
Detailed Description
Questions: Does exercise improve physical performance, activity, and quality of life in obese diabetic patients with chronic kidney disease? Design: Randomized controlled trial with concealed allocation, intention-to-treat analysis, and blinded assessment.
Participants: Sixty people aged between 35and 60 years were admitted to a department of Internal medicine .Cairo University hospitals divided randomly into two Groups Intervention: group 1 received aerobic exercises. Patients exercise at 40 to 60% of maximum heart rate. The exercise period comprised the following: the warming up phase (3-5 min), which included aerobic movement exercise of range of motion joints: rotating the wrist (20 rpm clockwise and 20 rpm counter clockwise), wrist up and down (up to 20 moves on the forearm), ankle twisting motion (40 rotations clockwise and counterclockwise around the ankles), and ankles up and down (20 times); the actual phase (20-30 min), which included cycle ergo meter exercise with 12-13 rated perceived exertion; and finally the cooling down phase (3-5 min) in the form of the same aerobic movements as performed in the warming up phase. Exercises done three times per week for three months and group 2 received resistance exercises.training of the lower extremities was performed three times per week for three months. Starting weights for knee extension and hip abduction and flexion were determined from a three-repetition maximum repetition maximum(RM) using ankle weights that can be adjusted in 1 lb. increments. A RM is the maximum weight that can be lifted three times with proper technique. Training started at approximately 60% of 3 RM for two sets of 10 repetitions and was increased to three sets as tolerated. When patients could perform three sets with correct technique, the weight was increased. In addition to knee extension and hip flexion and abduction, ankle dorsiflexion and plantar flexion were performed during each exercise session Outcome measures: physical activity was measured via timed up and go test, sit to stand test, number of sit-to-stand-to-sit cycles in 60 seconds, 6 minutes walking test. Obesity was measured by BMI, waist circumference and waist to hip ratio. Also Blood pressure (systolic/diastolic blood pressures, Mean blood pressure, heart rate and blood glucose were measured before exercise. The perception of exercise intensity was assessed by Original Borg Scale. All measurements were taken at the beginning and after three months of treatment.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Cairo, Egypt, 12613
- Cairo University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Chronic kidney disease Stages 2-4
- body mass index ≥30
- Diabetes mellitus
Exclusion Criteria:
- Uncontrolled hypertension
- Uncontrolled diabetes mellitus.
- Cardiac failure
- Motor disorders
- Dementia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
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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.
Other Names:
|
|
Experimental: Resistance training
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.
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body mass index
Time Frame: 12 week
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The weight by kilogram divided by height in square meters.
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12 week
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Manal K Youssef, phD, Cairo University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T. REC/012/002608
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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