Exercise Program on Quality of Life and Stress in Children Undergoing Hemodialysis

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05980351
Collaborator
(none)
60
2
2

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Other: exercise
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Exercise Program on Quality of Life and Stress in Children Undergoing Hemodialysis
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Study group

This group will receive exercise program

Other: exercise
The children will receive exercise program(stretching exercise,range of motion exercise and isometric exercise)

No Intervention: Control group

This group will receive routine hospital care

Outcome Measures

Primary Outcome Measures

  1. Children Quality Of Life [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

  2. Stress [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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.

Exclusion Criteria:
  • Children with physical disabilities.

  • Children on tranquilizers or sedative medications.

  • Children with a femoral dialysis catheter& internal jugular vein catheter

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shimaa Hassan Khalf allah, Assistant lecturer, Assiut University
ClinicalTrials.gov Identifier:
NCT05980351
Other Study ID Numbers:
  • Exercise on QOL and stress
First Posted:
Aug 8, 2023
Last Update Posted:
Aug 9, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Shimaa Hassan Khalf allah, Assistant lecturer, Assiut University

Study Results

No Results Posted as of Aug 9, 2023