Chronic Renal DiseaseNCT05383261
The Impact of the Social Factors and Rehabilitation Program to Address the Implications on Kidney Failure in Hail
An observational study of Chronic Renal Disease, run by University of Hail at 1 site in Saudi Arabia.
Trial summary
The aims of our study to evaluate the effect of social factors and medical rehabilitation program on kidney function and quality of life among chronic kidney disease patients. Read more about this study
- Who is it for?
- Ages 40 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Renal Disease
- What is being tested?
- exercise
- How many people
- 75 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 5 Jul 2022to 5 Dec 2022
- Phase
- Observational
- 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 40 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: participants with CKD stages (3 and 4) will be participated in this study, their ages ranged from 40 to 60 years. Both sexes will be included. Participants should be: Saudi persons living in Hail City, married, both genders,
Who may be able to join
- participants with CKD stages (3 and 4) will be participated in this study, their ages ranged from 40 to 60 years. Both sexes will be included.
- Participants should be: Saudi persons living in Hail City, married, both genders,
Who cannot join
- (1) Severe chronic cardiac problems. (2) Chronic chest disease. (3) Chronic inflammatory orthopedic disorders and rheumatoid arthritis. (4) Mental impairments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of the Social Factors and Medical Rehabilitation Program to Address the Implications on Kidney Failure Disease in Hail Region (Under the Vision 2030)
The aims of our study to evaluate the effect of social factors and medical rehabilitation program on kidney function and quality of life among chronic kidney disease patients.
Read the detailed description
- This study aims to evaluate the effect of social factors and medical rehabilitation program on kidney function and quality of life among chronic kidney disease patients.
- Identify the health problems facing patients with kidney failure in Hail region.
- Detect the reality of the problems facing patients with kidney failure in Hail region and ways to reduce them.
- Identify the family, psychological, economic and social problems facing patients with kidney failure in Hail region.
- Conditions
- Chronic Renal Disease
- Being tested
- exercise
- Keywords
- Renal failure patients -Saudi community - social program
- 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.
exerciseOther
aerobic and resisted ex
| Study group | Role | What they receive |
|---|---|---|
| control | patients will take medical treatment only
patients will receive medical treatment in addition to aerobic exercises Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walk test (6MWT). And Kidney Disease and Quality of Life (KDQOL™-36)
6-minute walk test (6MWT). And Kidney Disease and Quality of Life (KDQOL™-36)
Measured: after 6 week
Secondary outcomes (1)
muscle power of lower limb
functional muscle test
Measured: after 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start5 Jul 2022
- Primary completion2 Dec 2022
- Study completion5 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hail
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelmoniem Ibrahim, University of Hail
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05383261
- Sponsor's protocol ID
- RG-191348
- Status last verified
- May 2023
- First submitted
- 16 May 2022
- Last updated
- 10 May 2023
- 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 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the Social Factors and Medical Rehabilitation Program to Address the Implications on Kidney Failure Disease in Hail Region (Under the Vision 2030)
- ClinicalTrials.gov ID
- NCT05383261
- Acronym / sponsor ID
- RG-191348
- Conditions
- Chronic Renal Disease
- Keywords
- Renal failure patients -Saudi community - social program
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of HailUniversity, hospital or other
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- 2 Dec 2022 (actual)
- Study completion
- 5 Dec 2022 (actual)
- First posted
- 20 May 2022 (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.
The aims of our study to evaluate the effect of social factors and medical rehabilitation program on kidney function and quality of life among chronic kidney disease patients.
Detailed description
- This study aims to evaluate the effect of social factors and medical rehabilitation program on kidney function and quality of life among chronic kidney disease patients.
- Identify the health problems facing patients with kidney failure in Hail region.
- Detect the reality of the problems facing patients with kidney failure in Hail region and ways to reduce them.
- Identify the family, psychological, economic and social problems facing patients with kidney failure in Hail region.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| control | – | Other: exercisepatients will take medical treatment only patients will receive medical treatment in addition to aerobic exercises |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- participants with CKD stages (3 and 4) will be participated in this study, their ages ranged from 40 to 60 years. Both sexes will be included. Participants should be: Saudi persons living in Hail City, married, both genders,
Key inclusion criteria (2 listed)
- participants with CKD stages (3 and 4) will be participated in this study, their ages ranged from 40 to 60 years. Both sexes will be included.
- Participants should be: Saudi persons living in Hail City, married, both genders,
Key exclusion criteria (1 listed)
- (1) Severe chronic cardiac problems. (2) Chronic chest disease. (3) Chronic inflammatory orthopedic disorders and rheumatoid arthritis. (4) Mental impairments.
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 |
|---|---|---|
| exerciseaerobic and resisted ex | Other | control |
Primary outcome
6-minute walk test (6MWT). And Kidney Disease and Quality of Life (KDQOL™-36)
Time frame: after 6 week
6-minute walk test (6MWT). And Kidney Disease and Quality of Life (KDQOL™-36)
1 secondary outcome
muscle power of lower limb
Time frame: after 6 week
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 10 May 2023.
- hhhhhhLink provided by the sponsor.
- hhhhhLink provided by the sponsor.
- 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.
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?
An observational study of Chronic Renal Disease, run by University of Hail at 1 site in Saudi Arabia.
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 2 inclusion and 1 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 10 May 2023. 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 Saudi Arabia. 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?
6-minute walk test (6MWT). And Kidney Disease and Quality of Life (KDQOL™-36) (time frame: after 6 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 10 May 2023.