- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05599646
Pedometer-Based Walking Intervention on Physical Activity Among Hemodialysis Patients
March 18, 2024 updated by: mohamed elsayed hamed elzeky, Mansoura University
Effects of Gamified Versus Traditional Pedometer-Based Walking Intervention on Physical Activity, Fatigue and Sleep Quality Among Hemodialysis Patients: A Quasi-Experimental Study
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
Study Overview
Status
Recruiting
Conditions
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
Study Type
Interventional
Enrollment (Estimated)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Mansoura, Egypt
- Recruiting
- Faculty of Nursing Mansoura University
-
Contact:
- mohamed E.H Elzeky, phd
- Phone Number: 01017860949
- Email: mohamadelzeky@mans.edu.eg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: control group
|
|
Experimental: traditional pedometer group
|
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
|
Experimental: gamified smartphone pedometer group
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
will be measured at baseline and after intervention [(after 12 weeks of walking program)]
|
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
|
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
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.
|
will be measured at baseline and after intervention [(after 12 weeks of walking program)]
|
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
|
will be measured at baseline and after intervention [(after 12 weeks of walking program)]
|
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
|
will be measured at baseline and after intervention [(after 12 weeks of walking program)]
|
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
|
will be measured at baseline and after intervention [(after 12 weeks of walking program)]
|
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
|
will be measured at baseline and after intervention [(after 12 weeks of walking program)]
|
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
|
will be measured at baseline and after intervention [(after 12 weeks of walking program)]
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 31, 2022
Primary Completion (Actual)
September 30, 2023
Study Completion (Estimated)
March 30, 2024
Study Registration Dates
First Submitted
October 24, 2022
First Submitted That Met QC Criteria
October 28, 2022
First Posted (Actual)
October 31, 2022
Study Record Updates
Last Update Posted (Actual)
March 19, 2024
Last Update Submitted That Met QC Criteria
March 18, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- mans
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Fatigue
-
Bakulev Scientific Center of Cardiovascular SurgeryFoundation for the Support of Physical Culture and Sports BECOME A CHAMPION; Autonomous Non-Profit organization of additional education sports school BECOME A CHAMPIONNot yet recruitingEfficacy, Self | Fatigue, Mental | Fatigue; Muscle, Heart | Fatigue; CombatRussian Federation
-
Universita di VeronaUniversity of Southern CaliforniaCompletedDiet, Healthy | Fasting | Fatigue, Mental | Fatigue; Muscle, HeartItaly
-
University of ZurichRecruitingVocal FatigueSwitzerland
-
KU LeuvenCompleted
-
Société des Produits Nestlé (SPN)Maastricht University Medical CenterCompleted
-
University of Applied Sciences for Health Professions...University of Wisconsin, MilwaukeeCompleted
-
Taoyuan General HospitalCompleted
-
Alaa Yousri Mahmoud AtiaUnknownMuscle FatigueEgypt
-
University Hospital, Clermont-FerrandLaboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques...CompletedNeuromuscular FatigueFrance
-
Central Hospital, Nancy, FranceUniversity of Lorraine; Institut National de Recherche et de Sécurité, Nancy...Unknown
Clinical Trials on traditional pedometer based walking intervention
-
Rigshospitalet, DenmarkNovo Nordisk A/S; Copenhagen University Hospital at Herlev; Danish Cancer Society and other collaboratorsCompleted
-
Arizona State UniversityKarolinska InstitutetCompleted
-
National Defense Medical Center, TaiwanMinistry of Science and Technology, TaiwanCompletedExercise | Happiness | Educational Problems
-
Albert Einstein College of MedicineCompletedCervical Cancer | Head and Neck Cancer | Lung Cancer | Brain Cancer | Gastrointestinal CancerUnited States
-
The University of Texas Medical Branch, GalvestonCompletedBreast Cancer | Physical ActivityUnited States
-
University of Southern DenmarkCompletedPhysical InactivityDenmark
-
University of GlasgowCompleted
-
University of California, San DiegoCompletedBreast CancerUnited States
-
University Hospital, MontpellierRecruitingHypertension, PulmonaryFrance
-
Boston CollegeCompleted