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Completed

NCT Number: NCT05599646

Pedometer-Based Walking Intervention on Physical Activity Among Hemodialysis Patients

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

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Nursing Mansoura University

Al Mansurah, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

traditional pedometer based walking intervention

Behavioral

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

gamified pedometer based walking intervention

Behavioral

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

Primary outcomes

  1. change in patients weekly step count

    Time frame: 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

    Time frame: 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 outcomes

  1. change in sleep quality

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: will be measured at baseline and after intervention [(after 12 weeks of walking program)]

    a checklist to assess diastolic blood pressure

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Effects of Gamified Versus Traditional Pedometer-Based Walking Intervention on Physical Activity, Fatigue and Sleep Quality Among Hemodialysis Patients: A Quasi-Experimental Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2025
First posted
Oct 31, 2022
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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