Physical InactivityNCT05599646
Pedometer-Based Walking Intervention on Physical Activity Among Hemodialysis Patients
A study testing traditional pedometer based walking intervention and gamified pedometer based walking intervention in people with Physical Inactivity and Fatigue, run by Mansoura University at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Physical Inactivity, Fatigue
- What is being tested?
- traditional pedometer based walking intervention and gamified pedometer based walking intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteEgypt
- Study dates
- 31 Oct 2022to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- The study will exclude patients with
- unstable angina,
- those with lower-limb amputation
- and those using wheelchairs.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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
- Conditions
- Physical Inactivity, Fatigue
- Being tested
- traditional pedometer based walking intervention, gamified pedometer based walking intervention
- Medical subject headings
- Sedentary Behavior, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traditional pedometer based walking interventionBehavioural
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 interventionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| traditional pedometer group | Experimental | Not described Receives: Behavioral: traditional pedometer based walking intervention |
| gamified smartphone pedometer group | Experimental | Not described Receives: Behavioral: gamified pedometer based walking intervention |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in patients weekly step count
Step count will be assessed using a pedometer.
Measured: 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
Measured: will be measured at baseline and after intervention [(after 12 weeks of walking program)]
Secondary outcomes (6)
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.
Measured: 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
Measured: will be measured at baseline and after intervention [(after 12 weeks of walking program)]
change in heart rate
a checklist to assess heart rate
Measured: will be measured at baseline and after intervention [(after 12 weeks of walking program)]
change in respiratory rate
a checklist to assess respiratory rate
Measured: 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
Measured: 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
Measured: will be measured at baseline and after intervention [(after 12 weeks of walking program)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start31 Oct 2022
- Primary completion30 Sep 2023
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohamed elsayed hamed elzeky, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05599646
- Sponsor's protocol ID
- mans
- Status last verified
- Mar 2024
- First submitted
- 24 Oct 2022
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elzeky MEH, Ramadan El-Shaboury RH, Salameh B, Samaan E, F M Shahine N, Abdelhamid A. Effects of gamified versus pedometer-based walking intervention on physical activity, fatigue, and sleep quality among hemodialysis patients: a quasi-experimental study. BMC Nephrol. 2025 Mar 3;26(1):108. doi: 10.1186/s12882-025-04012-7.
PubMed 40033223
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05599646
- Acronym / sponsor ID
- mans
- Conditions
- Physical Inactivity, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 31 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| traditional pedometer group | Experimental | Behavioral: traditional pedometer based walking intervention |
| gamified smartphone pedometer group | Experimental | Behavioral: gamified pedometer based walking intervention |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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 ,
Key exclusion criteria (4 listed)
- The study will exclude patients with
- unstable angina,
- those with lower-limb amputation
- and those using wheelchairs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| traditional pedometer based walking interventionParticipants 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 | Behavioural | traditional pedometer group |
| gamified pedometer based walking interventionParticipants 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 | Behavioural | gamified smartphone pedometer group |
Primary outcome
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.
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
6 secondary outcomes
change in sleep quality
Time frame: 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)]
change in heart rate
Time frame: 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)]
change in systolic blood pressure
Time frame: 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)]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Derived from this study: PubMed 40033223Elzeky MEH, Ramadan El-Shaboury RH, Salameh B, Samaan E, F M Shahine N, Abdelhamid A. Effects of gamified versus pedometer-based walking intervention on physical activity, fatigue, and sleep quality among hemodialysis patients: a quasi-experimental study. BMC Nephrol. 2025 Mar 3;26(1):108. doi: 10.1186/s12882-025-04012-7.
- Individual participant dataSharing planned: No
Related trials for Physical Inactivity
Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
Recruiting
Yoga vs. Stretching-Strengthening: Physical Fitness in Sedentary Young Adults
Sedentary Lifestlye, Exercise
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Recruiting
Scalable TELeheaLth Cancer CARe: The STELLAR Program to Treat Cancer Risk Behaviors
Obesity, Smoking Cessation
Not yet recruiting
Be Well at Work-Plus: A Depression and Physical Activity Intervention for Hospital Service Workers (Aim 3)
Depression, Physical Inactivity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing traditional pedometer based walking intervention and gamified pedometer based walking intervention in people with Physical Inactivity and Fatigue, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in patients weekly step count (time frame: will be measured at baseline and after intervention [(after 12 weeks of walking program)]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05599646, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.