Pedometer-Based Walking Intervention on Physical Activity Among Hemodialysis Patients

NCT05599646 | Completed

• 1 other identifier: mans
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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

Conditions

Physical Inactivity; Fatigue

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• change in sleep quality

  will be measured at baseline and after intervention [(after 12 weeks of walking program)]

• change in functional status

  will be measured at baseline and after intervention [(after 12 weeks of walking program)]

• change in heart rate

  will be measured at baseline and after intervention [(after 12 weeks of walking program)]

• change in respiratory rate

  will be measured at baseline and after intervention [(after 12 weeks of walking program)]

• change in systolic blood pressure

  will be measured at baseline and after intervention [(after 12 weeks of walking program)]

Study Arms (3)

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

Interventions

traditional pedometer based walking intervention BEHAVIORAL

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

traditional pedometer group

gamified pedometer based walking intervention BEHAVIORAL

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

gamified smartphone pedometer group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• The study will exclude patients with
• unstable angina,
• those with lower-limb amputation
• and those using wheelchairs.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Nursing Mansoura University

Al Mansurah, Egypt

Location

Related Publications (1)

• 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.

  PMID: 40033223 DERIVED

MeSH Terms

Conditions

Sedentary Behavior; Fatigue

Condition Hierarchy (Ancestors)

Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer at medical surgical nursing

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: October 31, 2022
• Study Start: October 31, 2022
• Primary Completion: September 30, 2023
• Study Completion: March 30, 2025
• Last Updated: May 13, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)