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Exercise for Chronic Kidney Diseases

Primary Purpose

Chronic Kidney Failure

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
exercises
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Failure focused on measuring chronic kidney failure, obesity, exercises

Eligibility Criteria

35 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

aerobic training

Resistance training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Body mass index
The weight by kilogram divided by height in square meters.

Secondary Outcome Measures

Full Information

First Posted
August 12, 2020
Last Updated
August 24, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04522115
Brief Title
Exercise for Chronic Kidney Diseases
Official Title
Effect of Exercise in Obese Patients With Chronic Kidney Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 5, 2020 (Actual)
Primary Completion Date
May 20, 2020 (Actual)
Study Completion Date
June 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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?
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Failure
Keywords
chronic kidney failure, obesity, exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
group 1 received aerobic exercises and group 2 received resistance exercises.
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
aerobic training
Arm Type
Experimental
Arm Description
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.
Arm Title
Resistance training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
exercises
Other Intervention Name(s)
resistance exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body mass index
Description
The weight by kilogram divided by height in square meters.
Time Frame
12 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manal K Youssef, phD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University
City
Cairo
ZIP/Postal Code
12613
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Exercise for Chronic Kidney Diseases

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