NCT05980351

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable quality-of-life

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable quality-of-life

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 8, 2023

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

August 9, 2023

Status Verified

August 1, 2023

Enrollment Period

1 month

First QC Date

July 29, 2023

Last Update Submit

August 7, 2023

Conditions

Keywords

ExerciseQuality of LifeStressHemodialysis children

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

    After 2 months

Study Arms (2)

Study group

EXPERIMENTAL

This group will receive exercise program

Other: exercise

Control group

NO INTERVENTION

This group will receive routine hospital care

Interventions

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

Study group

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Children with physical disabilities.
  • Children on tranquilizers or sedative medications.
  • Children with a femoral dialysis catheter\& internal jugular vein catheter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Shimaa Hassan Khalf allah, PHD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

July 29, 2023

First Posted

August 8, 2023

Study Start

August 1, 2023

Primary Completion

September 1, 2023

Study Completion

September 30, 2023

Last Updated

August 9, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share