Clinical trial NCT05599646: Pedometer-Based Walking Intervention on Physical Activity Among Hemodialysis Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Inactivity
Fatigue
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-10-31
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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

Eligibility criteria: 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.

Primary outcomes:
measure: change in patients weekly step count
timeFrame: will be measured at baseline and after intervention [(after 12 weeks of walking program)]
measure: change in fatigue level
timeFrame: will be measured at baseline and after intervention [(after 12 weeks of walking program)]
Secondary outcomes:
measure: change in sleep quality
timeFrame: will be measured at baseline and after intervention [(after 12 weeks of walking program)]
measure: change in functional status
timeFrame: will be measured at baseline and after intervention [(after 12 weeks of walking program)]
measure: change in heart rate
timeFrame: will be measured at baseline and after intervention [(after 12 weeks of walking program)]
measure: change in respiratory rate
timeFrame: will be measured at baseline and after intervention [(after 12 weeks of walking program)]
measure: change in systolic blood pressure
timeFrame: will be measured at baseline and after intervention [(after 12 weeks of walking program)]
measure: change in diastolic blood pressure
timeFrame: will be measured at baseline and after intervention [(after 12 weeks of walking program)]
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Faculty of Nursing Mansoura University
Study officials:
References: