Pedometer-Based Walking Intervention on Physical Activity Among Hemodialysis Patients

Fatigue Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05599646
• Other study ID #: mans
• Status: Recruiting
• Phase: N/A
• Start date: October 31, 2022
• Est. completion date: March 30, 2024

Study information

• Verified date: March 2024
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: March 30, 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatigue
• Physical Inactivity

Intervention

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
• 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

Locations

Country	Name	City	State
Egypt	Faculty of Nursing Mansoura University	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)]
Primary	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	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)]
Secondary	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)]
Secondary	change in heart rate	a checklist to assess heart rate	will be measured at baseline and after intervention [(after 12 weeks of walking program)]
Secondary	change in respiratory rate	a checklist to assess respiratory rate	will be measured at baseline and after intervention [(after 12 weeks of walking program)]
Secondary	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)]
Secondary	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)]