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Pedometer-Based Walking Intervention on Physical Activity Among Hemodialysis Patients

Primary Purpose

Physical Inactivity, Fatigue

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
traditional pedometer based walking intervention
gamified pedometer based walking intervention
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Physical Inactivity

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Nursing Mansoura UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

traditional pedometer group

gamified smartphone pedometer group

control group

Arm Description

Outcomes

Primary Outcome Measures

change in patients weekly step count
Step count will be assessed using a pedometer.
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

Secondary Outcome Measures

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.
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
change in heart rate
a checklist to assess heart rate
change in respiratory rate
a checklist to assess respiratory rate
change in systolic blood pressure
a checklist to assess systolic blood pressure
change in diastolic blood pressure
a checklist to assess diastolic blood pressure

Full Information

First Posted
October 24, 2022
Last Updated
March 13, 2023
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT05599646
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Inactivity, Fatigue

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
traditional pedometer group
Arm Type
Experimental
Arm Title
gamified smartphone pedometer group
Arm Type
Experimental
Arm Title
control group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
traditional pedometer based walking intervention
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
gamified pedometer based walking intervention
Intervention Description
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 Outcome Measure Information:
Title
change in patients weekly step count
Description
Step count will be assessed using a pedometer.
Time Frame
will be measured at baseline and after intervention [(after 12 weeks of walking program)]
Title
change in fatigue level
Description
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
Time Frame
will be measured at baseline and after intervention [(after 12 weeks of walking program)]
Secondary Outcome Measure Information:
Title
change in sleep quality
Description
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.
Time Frame
will be measured at baseline and after intervention [(after 12 weeks of walking program)]
Title
change in functional status
Description
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
Time Frame
will be measured at baseline and after intervention [(after 12 weeks of walking program)]
Title
change in heart rate
Description
a checklist to assess heart rate
Time Frame
will be measured at baseline and after intervention [(after 12 weeks of walking program)]
Title
change in respiratory rate
Description
a checklist to assess respiratory rate
Time Frame
will be measured at baseline and after intervention [(after 12 weeks of walking program)]
Title
change in systolic blood pressure
Description
a checklist to assess systolic blood pressure
Time Frame
will be measured at baseline and after intervention [(after 12 weeks of walking program)]
Title
change in diastolic blood pressure
Description
a checklist to assess diastolic blood pressure
Time Frame
will be measured at baseline and after intervention [(after 12 weeks of walking program)]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Faculty of Nursing Mansoura University
City
Mansoura
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mohamed E.H Elzeky, phd
Phone
01017860949
Email
mohamadelzeky@mans.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No

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Pedometer-Based Walking Intervention on Physical Activity Among Hemodialysis Patients

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