Quality of LifeNCT05980351
Exercise Program on Quality of Life and Stress in Children Undergoing Hemodialysis
A study testing exercise in people with Quality of Life, run by Assiut University.
Trial summary
Despite the benefits of physical exercises among children with chronic illness, the children avoid to engage in different physical activities because their parent and the child also were faired to happen any complication to child. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Quality of Life
- What is being tested?
- exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 30 Sep 2023
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children aged from 6-18years with chronic renal failure.
- All children are stable on dialysis for 2 months (Blood pressure under medical control and stable blood sugar).
- All children are free from lower extremity graft and any lower limb pathology.
- Children do not take exercise in 6 months before treatment.
- Willing to participate in the study and attend the exercise schedule.
- Children able to follow verbal commands.
Who cannot join
- Children with physical disabilities.
- Children on tranquilizers or sedative medications.
- Children with a femoral dialysis catheter\& internal jugular vein catheter
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Exercise Program on Quality of Life and Stress in Children Undergoing Hemodialysis
Despite the benefits of physical exercises among children with chronic illness, the children avoid to engage in different physical activities because their parent and the child also were faired to happen any complication to child. The lack of activity and sedentary life style among these children result in reduced quality of life in addition to behavioral and social problems and finally become independent in most of activities of daily living. Therefore, the primary aim of this study will to practice and teach the children exercise programs in order to improve the quality of life and reduce stress in children undergoing hemodialysis. Therefore aim of this study is to: Determine the effect of exercise program on quality of life and stress in children undergoing hemodialysis.
Read the detailed description
- The researcher will go to hospital and will take all children that present in hemodialysis unit, then will make random assignment of children to study or control group .The control group will receive routine care while the study group will receive exercise program.
- The exercise program will conduct three days per week giving an interval of 24 hours between sessions. In the first hour the child not make any activity, then first 20 min from second hour of hemodialysis the child will receive stretching exercise, first 20 min from third hour the child will receive range of motion exercise finally first 20 min from forth hour the child will practice isometric exercise.
- This procedure will continue for 2 months and the end of time the research will make posttest for both groups. The intensity for resistance training will determined individually. Depending up on the child exercise tolerance, each set will performed 10 gradually increase to 15 repetitions.
- Conditions
- Quality of Life
- Being tested
- exercise
- Keywords
- Exercise, Quality of Life, Stress, Hemodialysis children
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
The children will receive exercise program(stretching exercise,range of motion exercise and isometric exercise)
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | This group will receive exercise program Receives: Other: exercise |
| Control group | No intervention | This group will receive routine hospital care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children Quality Of Life
Health Related Quality Of Life (HRQOL): Will use to measure children quality of life which includes the four domains (physical, emotional, social and school performance), each domain consists of 5 questions. Each question will earn score from (0-4) according to their answer as the following:
4 means= never have a problem 3 means= almost never a problem 2 means= sometimes a problem
1 means= it is often a problem 0 means = almost always a problem
Measured: After 2 months
Stress
Tool (3): Perceived Stress Scale The Perceived Stress Scale (PSS) is a classic stress assessment instrument. This tool, helping the investigators to understands how different situations affect participants feelings and perceived stress. The questions in this scale ask about participants feelings and thoughts. In each case, the child will be asked to indicate how often felt or thought a certain way.
This scale consisted of 10 questions; each question will earn score from (0-4) according to their answer as the following:
4 means= very often 3 means= fairly often 2 means= sometimes
1 means= almost never 0 means = never Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress.
Measured: After 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start1 Aug 2023 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimaa Hassan Khalf allah, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05980351
- Sponsor's protocol ID
- Exercise on QOL and stress
- Status last verified
- Aug 2023
- First submitted
- 29 Jul 2023
- Last updated
- 9 Aug 2023
- Results posted
- No
- 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 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise Program on Quality of Life and Stress in Children Undergoing Hemodialysis
- ClinicalTrials.gov ID
- NCT05980351
- Acronym / sponsor ID
- Exercise on QOL and stress
- Conditions
- Quality of Life
- Keywords
- Exercise, Quality of Life, Stress, Hemodialysis children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 8 Aug 2023 (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.
Despite the benefits of physical exercises among children with chronic illness, the children avoid to engage in different physical activities because their parent and the child also were faired to happen any complication to child. The lack of activity and sedentary life style among these children result in reduced quality of life in addition to behavioral and social problems and finally become independent in most of activities of daily living. Therefore, the primary aim of this study will to practice and teach the children exercise programs in order to improve the quality of life and reduce stress in children undergoing hemodialysis. Therefore aim of this study is to: Determine the effect of exercise program on quality of life and stress in children undergoing hemodialysis.
Detailed description
- The researcher will go to hospital and will take all children that present in hemodialysis unit, then will make random assignment of children to study or control group .The control group will receive routine care while the study group will receive exercise program.
- The exercise program will conduct three days per week giving an interval of 24 hours between sessions. In the first hour the child not make any activity, then first 20 min from second hour of hemodialysis the child will receive stretching exercise, first 20 min from third hour the child will receive range of motion exercise finally first 20 min from forth hour the child will practice isometric exercise.
- This procedure will continue for 2 months and the end of time the research will make posttest for both groups. The intensity for resistance training will determined individually. Depending up on the child exercise tolerance, each set will performed 10 gradually increase to 15 repetitions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: exerciseThis group will receive exercise program |
| Control group | No intervention | –This group will receive routine hospital care |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Children aged from 6-18years with chronic renal failure.
Key exclusion criteria (3 listed)
- Children with physical disabilities.
- Children on tranquilizers or sedative medications.
- Children with a femoral dialysis catheter\& internal jugular vein catheter
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 |
|---|---|---|
| exerciseThe children will receive exercise program(stretching exercise,range of motion exercise and isometric exercise) | Other | Study group |
Primary outcome
Children Quality Of Life
Time frame: After 2 months
Health Related Quality Of Life (HRQOL): Will use to measure children quality of life which includes the four domains (physical, emotional, social and school performance), each domain consists of 5 questions. Each question will earn score from (0-4) according to their answer as the following: 4 means= never have a problem 3 means= almost never a problem 2 means= sometimes a problem 1 means= it is often a problem 0 means = almost always a problem
Stress
Time frame: After 2 months
Tool (3): Perceived Stress Scale The Perceived Stress Scale (PSS) is a classic stress assessment instrument. This tool, helping the investigators to understands how different situations affect participants feelings and perceived stress. The questions in this scale ask about participants feelings and thoughts. In each case, the child will be asked to indicate how often felt or thought a certain way. This scale consisted of 10 questions; each question will earn score from (0-4) according to their answer as the following: 4 means= very often 3 means= fairly often 2 means= sometimes 1 means= almost never 0 means = never Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Quality of Life, run by Assiut University.
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 6 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: status not confirmed, as of the sponsor's last update on 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shimaa Hassan Khalf allah, PHD (01097248758, shimaa_hassan@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children Quality Of Life (time frame: After 2 months). The study lists 2 primary outcomes in all. 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 9 Aug 2023.