NCT05251623

Brief Summary

The aim of this study is to investigate the effects of a walking program on exercise capacity and quality of life in patient with COPD. Method: Patients with COPD were randomly assigned to pedometer group (PG) or control group (CON). Subjects in PG walked to target steps daily with pedometer for 6 weeks. Before and after the program, the following measurements were performed: pulmonary function test (PFT), daily steps, Six-Minute Walk Test (6MWT), COPD Assessment Test (CAT), and quality of life questionnaire (SF-12).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Mar 2018

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

December 30, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 23, 2022

Completed
Last Updated

February 23, 2022

Status Verified

February 1, 2022

Enrollment Period

1 month

First QC Date

December 30, 2021

Last Update Submit

February 10, 2022

Conditions

Keywords

COPDpedometerphysical activityquality of life

Outcome Measures

Primary Outcomes (8)

  • tidal volume

    the amount of air that moves in or out of the lungs with each respiratory cycle. It is measured by spirometers.

    week 0

  • tidal volume

    the amount of air that moves in or out of the lungs with each respiratory cycle. It is measured by spirometers.

    week 7

  • Short-form 12 questionnaire (SF-12)

    The SF-12 is a quality of life questionnaire. The scores range from 0 (worst conceivable QOL) to 100 (best conceivable QOL)

    week 0

  • Short-form 12 questionnaire (SF-12)

    The SF-12 is a quality of life questionnaire. The scores range from 0 (worst conceivable QOL) to 100 (best conceivable QOL)

    week 7

  • 6 minute walking test

    walking distance

    week 0

  • 6 minute walking test

    walking distance

    week 7

  • daily steps

    the number of total walking steps per day which is measured by pedometer.

    week0

  • daily steps

    the number of total walking steps per day which is measured by pedometer.

    week 7

Study Arms (2)

pedometer

EXPERIMENTAL

walking with pedometer

Other: walking program

control

NO INTERVENTION

no intervention

Interventions

Subjects in PG walked to target steps daily with pedometer for 6 weeks

pedometer

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosed with COPD
  • in a medically stable condition
  • able to walk unassisted
  • ≥ 40 years of age

You may not qualify if:

  • oxygen therapy,
  • hemodynamic instability,
  • signs/symptoms of acute infection
  • severe neurological, musculoskeletal, or cardiovascular conditions that affect walking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taoyuan General Hospital

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveMotor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Yen-Huey Chen, PhD

    Chang Gung University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assist professor

Study Record Dates

First Submitted

December 30, 2021

First Posted

February 23, 2022

Study Start

March 1, 2018

Primary Completion

March 31, 2018

Study Completion

March 31, 2019

Last Updated

February 23, 2022

Record last verified: 2022-02

Locations