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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Egypt1 site
  • Cairo University

    Cairo, 12613

Other trials in Egypt

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.

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 groups in NCT04522115
Study groupRoleWhat they receive
aerobic trainingExperimentalEach 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 trainingExperimentalResistance 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.

  1. 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.

  1. First posted21 Aug 2020
  2. Study start5 Jan 2020
  3. Primary completion20 May 2020
  4. Study completion3 Jun 2020

Resources

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)
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

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.

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