Chronic Kidney FailureNCT04522115
Exercise for Chronic Kidney Diseases
A study testing exercises in people with Chronic Kidney Failure, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Chronic Kidney Failure
- What is being tested?
- exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jan 2020to 3 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Chronic kidney disease Stages 2-4
- body mass index ≥30
- Diabetes mellitus
Who cannot join
- Uncontrolled hypertension
- Uncontrolled diabetes mellitus.
- Cardiac failure
- Motor disorders
- Dementia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
Read the 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.
- Conditions
- Chronic Kidney Failure
- Being tested
- exercises
- Keywords
- chronic kidney failure, obesity, exercises
- Medical subject headings
- Kidney Failure, Chronic, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercisesOther
Also called resistance exercises
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index
The weight by kilogram divided by height in square meters.
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start5 Jan 2020
- Primary completion20 May 2020
- Study completion3 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney FailureStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- group 1 received aerobic exercises and group 2 received resistance exercises.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manal k. youssef, Cairo University
- Investigators
- Manal K Youssef, phD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04522115
- Sponsor's protocol ID
- P.T. REC/012/002608
- Status last verified
- Aug 2020
- First submitted
- 12 Aug 2020
- Last updated
- 25 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise in Obese Patients With Chronic Kidney Diseases
- ClinicalTrials.gov ID
- NCT04522115
- Acronym / sponsor ID
- P.T. REC/012/002608
- Conditions
- Chronic Kidney Failure
- Keywords
- chronic kidney failure, obesity, exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Jan 2020 (actual)
- Primary completion
- 20 May 2020 (actual)
- Study completion
- 3 Jun 2020 (actual)
- First posted
- 21 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- group 1 received aerobic exercises and group 2 received resistance exercises.
| Arm | Type | Receives |
|---|---|---|
| aerobic training | Experimental | Other: exercisesEach 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 training | Experimental | Other: exercisesResistance 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. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Chronic kidney disease Stages 2-4
- body mass index ≥30
- Diabetes mellitus
Key exclusion criteria (5 listed)
- Uncontrolled hypertension
- Uncontrolled diabetes mellitus.
- Cardiac failure
- Motor disorders
- Dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercisesAlso: resistance exercisesGroup(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 | Resistance training, aerobic training |
Primary outcome
Body mass index
Time frame: 12 week
The weight by kilogram divided by height in square meters.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manal K Youssef, phD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercises in people with Chronic Kidney Failure, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body mass index (time frame: 12 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2020.