Pedometer-Based Walking Intervention on Physical Activity Among Hemodialysis Patients

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Physical Inactivity, Fatigue

Intervention / Treatment
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* Behavioral: traditional pedometer based walking intervention
* Behavioral: gamified pedometer based walking intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: traditional pedometer group<br> | Behavioral: traditional pedometer based walking intervention<br>* 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<br>|
| Experimental: gamified smartphone pedometer group<br> | Behavioral: gamified pedometer based walking intervention<br>* 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<br>|
| No Intervention: control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in patients weekly step count | Step count will be assessed using a pedometer. | will be measured at baseline and after intervention [(after 12 weeks of walking program)] | 
| change in fatigue level | 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 | will be measured at baseline and after intervention [(after 12 weeks of walking program)] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in sleep quality | 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. | will be measured at baseline and after intervention [(after 12 weeks of walking program)] | 
| change in functional status | 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 | will be measured at baseline and after intervention [(after 12 weeks of walking program)] | 
| change in heart rate | a checklist to assess heart rate | will be measured at baseline and after intervention [(after 12 weeks of walking program)] | 
| change in respiratory rate | a checklist to assess respiratory rate | will be measured at baseline and after intervention [(after 12 weeks of walking program)] | 
| change in systolic blood pressure | a checklist to assess systolic blood pressure | will be measured at baseline and after intervention [(after 12 weeks of walking program)] | 
| change in diastolic blood pressure | a checklist to assess diastolic blood pressure | will be measured at baseline and after intervention [(after 12 weeks of walking program)] |