Pedometer-Based Walking Intervention on Physical Activity Among Hemodialysis Patients

Sponsor
Mansoura University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05599646
Collaborator
(none)
90
1
3
5
18.1

Study Details

Study Description

Brief Summary

Patients undergoing HD are mostly physically inactive and have reduced functional capacities compared to healthy individuals which contributes to a decreased quality of life and consequently increases the risk of mortality

Condition or Disease Intervention/Treatment Phase
  • Behavioral: traditional pedometer based walking intervention
  • Behavioral: gamified pedometer based walking intervention
N/A

Detailed Description

Physical activity has been shown to have various positive effects on HD patients . Some of the important benefits linked to exercise include an improvement in physical fitness , aerobic capacity , dialysis adequacy (measured as urea Kt/V) , quality of life , and reduced depressive symptoms .Walking can be considered as the most natural form of PA as it is easily performed by everyone except for the seriously disabled or very frail. Smartphones and their embedded computer technologies are increasingly being used to promote physical activity. Gamification presents itself as a promising approach to overcome a loss of interest, increase user engagement , raise the quality of health behaviors , and motivate users to use mHealth apps for a sustained period

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Effects of Gamified Versus Traditional Pedometer-Based Walking Intervention on Physical Activity, Fatigue and Sleep Quality Among Hemodialysis Patients: A Quasi-Experimental Study
Actual Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: traditional pedometer group

Behavioral: traditional pedometer based walking intervention
Participants were recommended to monitor their step count using traditional pedometer and to increase their steps by 10% compared with the prior week. the intervention will continue for 12 weeks

Experimental: gamified smartphone pedometer group

Behavioral: gamified pedometer based walking intervention
Participants were recommended to monitor their step count using gamified pedometer, earn money, compete friends and to increase their steps by 10% compared with the prior week. the intervention will continue for 12 weeks

No Intervention: control group

Outcome Measures

Primary Outcome Measures

  1. change in patients weekly step count [will be measured at baseline and after intervention [(after 12 weeks of walking program)]]

    Step count will be assessed using a pedometer.

  2. change in fatigue level [will be measured at baseline and after intervention [(after 12 weeks of walking program)]]

    Brief Fatigue Inventory questionnaire will evaluate the level of current fatigue and usual fatigue in the last 24 hours.A score of 0 means no fatigue and a score of 10 means the highest level of fatigue. The total score of fatigue was obtained through summing up the score of questions 2e10 (nine items) and dividing by nine

Secondary Outcome Measures

  1. change in sleep quality [will be measured at baseline and after intervention [(after 12 weeks of walking program)]]

    Sleep disorders will be assessed using the arabic version of the Pittsburgh Sleep Quality index (PSQI).The scores were added to yield a global PSQI score in the range 0-21, with a higher score indicating poorer sleep quality.

  2. change in functional status [will be measured at baseline and after intervention [(after 12 weeks of walking program)]]

    The Short Physical Performance Battery (SPPB) is designed to measure functional status and physical performance.Each task is scored out of 4, with the scores from the three tests summed to give a total, with a maximum of 12 and a minimum of 0. A higher score indicates a higher level of function, while lower scores indicate a lower level of function

  3. change in heart rate [will be measured at baseline and after intervention [(after 12 weeks of walking program)]]

    a checklist to assess heart rate

  4. change in respiratory rate [will be measured at baseline and after intervention [(after 12 weeks of walking program)]]

    a checklist to assess respiratory rate

  5. change in systolic blood pressure [will be measured at baseline and after intervention [(after 12 weeks of walking program)]]

    a checklist to assess systolic blood pressure

  6. change in diastolic blood pressure [will be measured at baseline and after intervention [(after 12 weeks of walking program)]]

    a checklist to assess diastolic blood pressure

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Inclusion criteria were 18 to less than 60 years of age,

  • under- going conventional hemodialysis three times a week,

  • hemodialysis period of three month or more,

  • having smartphone aneroid access (second group),

  • Available for telephone follow-up ,

  • ability to read and write ,

  • and being ambulatory,

  • Patients using a cane or other assistive device will be eligible and Patients provided informed consent to participate.

Exclusion Criteria:

The study will exclude patients with

  • unstable angina,

  • those with lower-limb amputation

  • and those using wheelchairs.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Nursing Mansoura University Mansoura Egypt

Sponsors and Collaborators

  • Mansoura University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
mohamed elsayed hamed elzeky, lecturer at medical surgical nursing, Mansoura University
ClinicalTrials.gov Identifier:
NCT05599646
Other Study ID Numbers:
  • mans
First Posted:
Oct 31, 2022
Last Update Posted:
Nov 17, 2022
Last Verified:
Nov 1, 2022
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 17, 2022