Chronic Kidney DiseasesNCT06862336
Interdialytic Resistance Exercises in with Chronic Kidney Diseases
A study testing intra-dialytic exercise program associated with medical treatment and inter-dialytic combined exercise program with their medications in people with Chronic Kidney Diseases, run by Cairo University at 1 site in Egypt.
Trial summary
Fifty chronic kidney disease patients' ages will range from 40 to 55 years. They will be selected from the dialysis unit. received intra-dialytic combined exercise program for 8 weeks(3 sessions/week), with their medical treatment. Read more about this study
- Who is it for?
- Ages 40 to 55 years
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- intra-dialytic exercise program associated with medical treatment and inter-dialytic combined exercise program with their medications
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2025to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Fifty patients with CKD, are on hemodialysis for longer than threemonths 3 sessions/ week.
- Theirageswillrangefrom40 to 55yearsold.
- Their body mass index is more than 18.5 and less than 29.9 %.
- 3-All patients have hemodynamic stability over the month before beginning the program.
Who cannot join
- 1. Severe Chest diseases(either obstructive or restrictive). 2. Clinical signs of a severe cardiac event.(eg, severe atherosclerosis, congestive heart failure), 3. Severepsychiatricorcognitiveimpairment,whounabletofollowcomment. 4. Neurological disorders affecting respiratory muscles or any muscular dystrophies(cervical disc or bulge).
- 5. Patients with severe self-limiting illness (e.g., cancer). 6. peripheral artery disease in lower extremities. 7. Systolic blood pressure < 180 mmHg, diastolic blood pressure more than 105 mmHg, or heart rate above 120 bpm during dialysis.
- 8. Patient with uncontrolled- diabetes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intradialytic Versus Interdialytic Resistance Exercises on Quality of Life in Patients with Chronic Kidney Diseases
Fifty chronic kidney disease patients' ages will range from 40 to 55 years. They will be selected from the dialysis unit. received intra-dialytic combined exercise program for 8 weeks(3 sessions/week), with their medical treatment.
- Conditions
- Chronic Kidney Diseases
- Being tested
- intra-dialytic exercise program associated with medical treatment, inter-dialytic combined exercise program with their medications
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intra-dialytic exercise program associated with medical treatmentProcedure or surgery
- Stretch for pectorals and calf muscles: Two sets - 3 times/ set.
- Breathing exercises associated with upper limb movement.
- Resistive exercise for hip abductors, hip flexors, and calf muscles by using theraband.
- Sit to stand strengthening exercises: -
inter-dialytic combined exercise program with their medicationsProcedure or surgery
receive the inter-dialytic combined exercise program with their medications. Like the study group except for diaphragmatic breathing instead of breathing with upper limb exercise.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | twenty-five patients with CKD will receive intra-dialytic combined exercise program for8 weeks(3 sessions/week), with their medical treatment. Receives: Procedure: intra-dialytic exercise program associated with medical treatment |
| Group B | Placebo comparator | twenty-five patients with CKD will receive the inter-dialytic combined exercise program with their medications. Receives: Procedure: inter-dialytic combined exercise program with their medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring quadriceps and cuff muscles power
From sitting or lying positions the normal dialytic positions by handheld dynamometer
Measured: pre intervention and re assessed after 2 months of treatment
Secondary outcomes (3)
Kidney disease quality of life F
Kidney disease quality of life questionnaire KDQoL-SF
Measured: pre intervention and re assessed after 2 months of treatment
chest expansion
From a standing position and comfortable clothes with relaxed shoulders and a straight back, the head will be aligned vertically. Putting the measuring tape around the armpits and closing the ends of the tape measurement not tightly nor loose, asking the patient to take deep breathing.
Measured: pre intervention and re assessed after 2 months of treatment
Six-minute walk test
Subjects will be instructed to walk from one end to the other of a 30-m hallway at their own pace while attempting to cover as much ground as possible in the allotted 6 min
Measured: pre intervention and re assessed after 2 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start20 Jan 2025
- Primary completion20 Mar 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira saad mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06862336
- Sponsor's protocol ID
- 012/005019
- Status last verified
- Mar 2025
- First submitted
- 2 Mar 2025
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intradialytic Versus Interdialytic Resistance Exercises on Quality of Life in Patients with Chronic Kidney Diseases
- ClinicalTrials.gov ID
- NCT06862336
- Acronym / sponsor ID
- 012/005019
- Conditions
- Chronic Kidney Diseases
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 20 Mar 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 6 Mar 2025 (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.
Fifty chronic kidney disease patients' ages will range from 40 to 55 years. They will be selected from the dialysis unit. received intra-dialytic combined exercise program for 8 weeks(3 sessions/week), with their medical treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: intra-dialytic exercise program associated with medical treatmenttwenty-five patients with CKD will receive intra-dialytic combined exercise program for8 weeks(3 sessions/week), with their medical treatment. |
| Group B | Placebo comparator | Procedure: inter-dialytic combined exercise program with their medicationstwenty-five patients with CKD will receive the inter-dialytic combined exercise program with their medications. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Fifty patients with CKD, are on hemodialysis for longer than threemonths 3 sessions/ week.
- Theirageswillrangefrom40 to 55yearsold.
- Their body mass index is more than 18.5 and less than 29.9 %.
- 3-All patients have hemodynamic stability over the month before beginning the program.
Key exclusion criteria (3 listed)
- 1. Severe Chest diseases(either obstructive or restrictive). 2. Clinical signs of a severe cardiac event.(eg, severe atherosclerosis, congestive heart failure), 3. Severepsychiatricorcognitiveimpairment,whounabletofollowcomment. 4. Neurological disorders affecting respiratory muscles or any muscular dystrophies(cervical disc or bulge).
- 5. Patients with severe self-limiting illness (e.g., cancer). 6. peripheral artery disease in lower extremities. 7. Systolic blood pressure < 180 mmHg, diastolic blood pressure more than 105 mmHg, or heart rate above 120 bpm during dialysis.
- 8. Patient with uncontrolled- diabetes.
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 |
|---|---|---|
| intra-dialytic exercise program associated with medical treatment* Stretch for pectorals and calf muscles: Two sets - 3 times/ set. * Breathing exercises associated with upper limb movement. * Resistive exercise for hip abductors, hip flexors, and calf muscles by using theraband. * Sit to stand strengthening exercises: - | Procedure or surgery | Group A |
| inter-dialytic combined exercise program with their medicationsreceive the inter-dialytic combined exercise program with their medications. Like the study group except for diaphragmatic breathing instead of breathing with upper limb exercise. | Procedure or surgery | Group B |
Primary outcome
Measuring quadriceps and cuff muscles power
Time frame: pre intervention and re assessed after 2 months of treatment
From sitting or lying positions the normal dialytic positions by handheld dynamometer
3 secondary outcomes
Kidney disease quality of life F
Time frame: pre intervention and re assessed after 2 months of treatment
chest expansion
Time frame: pre intervention and re assessed after 2 months of treatment
Six-minute walk test
Time frame: pre intervention and re assessed after 2 months of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intra-dialytic exercise program associated with medical treatment and inter-dialytic combined exercise program with their medications in people with Chronic Kidney Diseases, 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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 6 Mar 2025. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Measuring quadriceps and cuff muscles power (time frame: pre intervention and re assessed after 2 months of treatment). 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 6 Mar 2025.