NCT07059559

Brief Summary

This study designed a over-knee automatic step counter device. Then, we evaluated its efficacy on renal function and oxidative stress in patients with chronic kidney disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 17, 2024

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 11, 2025

Completed
Last Updated

July 11, 2025

Status Verified

July 1, 2025

Enrollment Period

12 months

First QC Date

July 1, 2025

Last Update Submit

July 1, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • Creatinine level

    Blood creatinine level was measured in mg/dL unit

    Day 0 and day 91

  • Malondialdehyde level

    Blood malondialdehyde level was measured in micromolar unit

    Day 0 and day 91

  • Superoxide dismutase activity level

    Blood superoxide dismutase activity level was measured in percent unit

    Day 0 and day 91

  • Estimated glomerular filtration rate level

    Estimated glomerular filtration rate level was measured in ml/min/1.73 m2 unit

    Day 0 and day 91

  • Estimated creatinine clearance level

    Estimated creatinine clearance level was measured in ml/min unit

    Day 0 and day 91

Study Arms (2)

Control group

NO INTERVENTION

Patients who join in odd-numbered order, such as 1st, 3rd, 5th, etc., will receive standard care as provided by the hospital (control group).

Rhythmic walking group

EXPERIMENTAL

Patients who join in even-numbered order, such as 2nd, 4th, 6th, etc., will receive a walking program. This involves continuous walking exercise for 30 minutes, once a day, three days a week, over a period of three months. During the walking sessions, patients will walk at a pace of 60 steps per minute, or one step per second.

Other: Rhythmic walking

Interventions

Patients who consent to participate and pass the screening process were randomly assigned to groups based on the order of their participation (random by sequence): control group or rhythmic walking group.

Rhythmic walking group

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female
  • Aged between 18 and 59 years
  • Diagnosed by a physician with chronic kidney disease stage 2-4, with a glomerular filtration rate (GFR) between 15-89 milliliters per minute, persisting for at least 3 months

You may not qualify if:

  • No musculoskeletal disorders that hinder walking, such as osteoarthritis
  • Not engaging in regular exercise (less than 3 times per week or less than 150 minutes per week)
  • Not regularly taking medications or supplements containing antioxidants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehabilitation Medicine Department, Chamni Hospital

Chamni, Changwat Buri Ram, 31110, Thailand

Location

Study Officials

  • Piyapong Prasertsri, Ph.D.

    Faculty of Allied Health Sciences, Burapha University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors were blinded to the intervention administered to each patient.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study is a randomized controlled trial. Patients who consent to participate and pass the screening process will be randomly assigned to groups based on the order of their participation (random by sequence). Patients who join in odd-numbered order, such as 1st, 3rd, 5th, etc., will receive standard care as provided by the hospital (control group). Patients who join in even-numbered order, such as 2nd, 4th, 6th, etc., will receive a walking program.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Dr.

Study Record Dates

First Submitted

July 1, 2025

First Posted

July 11, 2025

Study Start

July 17, 2024

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

July 11, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

There is no plan to make individual participant data (IPD) available to other researchers.

Locations