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Pedometer Assisted Physical Activity in Individuals With COPD. A Multicenter Randomized Controlled Trial.

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status

Completed

Phase

Not Applicable

Locations

Indonesia

Study Type

Interventional

Intervention

pedometer home based rehabilitation

Exercise training

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring Pulmonary rehabilitation; Tele-medicine; Exercise capacity; Dyspnoea; Quality of life

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Individuals with COPD as defined by the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) guidelines,2 40-80 years old, were recruited from the outpatient clinics of Moewardi and Mohammad Rabain hospitals.
All subjects had to be in stable conditions as assessed by absence of worsening in symptoms, i.e. no change in cough, and/or sputum beyond day-to-day variability which would have been sufficient to warrant a change in the management prescribed at discharge from hospitals or prescribed at home by their GP, and stability in blood gas values (e.g. no respiratory acidosis).

Exclusion Criteria:

Individuals refusing to participate, participated in a pulmonary rehabilitation program during the previous 6 months, or with active malignancy, previous lung surgery, unstable cardiovascular diseases, orthopaedic and/or neuromuscular diseases interfering with their ability to walk, or inability to connect with internet and operate WhatsApp video call applications were excluded.

Sites / Locations

Pulmonary department of medical faculty Universitas Sebelas Maret

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Study Group (pedometer)

Control Group

Arm Description

Participants received an Omron HJ 321 pedometer (Omron Healthcare Co Ltd, Kyoto, Japan) and were asked to walk at home at the fastest step pace as possible, for at least 30 minutes every day, up to 6 weeks.

participants received supervised exercise training at outpatient clinics for total 18 sessions (3 weekly sessions for 6 weeks).

Outcomes

Primary Outcome Measures

Exercise Tolerance

Exercise tolerance was assessed by mean of the 6MWT according to accepted

Secondary Outcome Measures

Physical Activity

Physical activity was measured as daily steps, based on an average step count of 7 days obtained from the pedometer.

Full Information

NCT ID

NCT05098964

First Posted

October 17, 2021

Last Updated

October 17, 2021

Sponsor

Yusup subagio sutanto

1. Study Identification

Unique Protocol Identification Number

NCT05098964

Brief Title

Pedometer Assisted Physical Activity in Individuals With COPD. A Multicenter Randomized Controlled Trial.

Official Title

Physical Activity in COPD

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

February 1, 2019 (Actual)

Primary Completion Date

February 29, 2020 (Actual)

Study Completion Date

December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Yusup subagio sutanto

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Home based and tele-rehabilitation programs may be potentially useful to deliver and to maintain the benefits in difficult-to-reach areas. Tele-health technologies allow for distribution of healthcare services and exchange of information between healthcare providers and patients in different geographical locations and provide an important tool to reach people living in rural communities. In a previous single center study, we had shown that a home pedometer assisted program to enhance physical activity was as effective as and cheaper than a standard outpatient supervised exercise training program.13 We wondered whether the results of that study 13 might be confirmed in a larger multicenter randomized controlled trial (RCT). Therefore the aim of this multicenter RCT was to evaluate the benefits and costs of a program of pedometer assisted physical activity as compared to standard hospital outpatient supervised exercise training program.

Detailed Description

A multicenter RCT was conducted in Moewardi (Surakarta, Central Jawa, Indonesia) and Mohammad Rabain (Muara Enim, South Sumatra, Indonesia) hospitals from February the 1st, 2019 to February the 29th 2020. The study was performed according to the Helsinki Declaration, approved by the Committee of Moewardi Hospital, Surakarta, Central Jawa, Indonesia (Number 713/IX/HREC/2018, September 26th, 2018 and Indonesian Ministry of Health).Participants with COPD as defined by the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) guidelines and eligible for this study were allocated into two groups using a randomly generated sequence. Before and after the program, the following outcome measures; 6MWT, BODE, physical activity, MRC and CAT Score.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Pulmonary rehabilitation; Tele-medicine; Exercise capacity; Dyspnoea; Quality of life

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

180 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Study Group (pedometer)

Arm Type

Experimental

Arm Description

Arm Title

Control Group

Arm Type

Experimental

Arm Description

participants received supervised exercise training at outpatient clinics for total 18 sessions (3 weekly sessions for 6 weeks).

Intervention Type

Device

Intervention Name(s)

pedometer home based rehabilitation

Other Intervention Name(s)

pedometer

Intervention Description

Home based pulmonary rehabilitation for 6 weeks using pedometer Omron HJ 321 pedometer (Omron Healthcare Co Ltd, Kyoto, Japan)

Intervention Type

Other

Intervention Name(s)

Exercise training

Intervention Description

Hospital based exercise training for 6 weeks

Primary Outcome Measure Information:

Title

Exercise Tolerance

Description

Exercise tolerance was assessed by mean of the 6MWT according to accepted

Time Frame

Before and after program (6 weeks)

Secondary Outcome Measure Information:

Title

Physical Activity

Description

Physical activity was measured as daily steps, based on an average step count of 7 days obtained from the pedometer.

Time Frame

Before and after program (6 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Individuals with COPD as defined by the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) guidelines,2 40-80 years old, were recruited from the outpatient clinics of Moewardi and Mohammad Rabain hospitals. All subjects had to be in stable conditions as assessed by absence of worsening in symptoms, i.e. no change in cough, and/or sputum beyond day-to-day variability which would have been sufficient to warrant a change in the management prescribed at discharge from hospitals or prescribed at home by their GP, and stability in blood gas values (e.g. no respiratory acidosis). Exclusion Criteria: Individuals refusing to participate, participated in a pulmonary rehabilitation program during the previous 6 months, or with active malignancy, previous lung surgery, unstable cardiovascular diseases, orthopaedic and/or neuromuscular diseases interfering with their ability to walk, or inability to connect with internet and operate WhatsApp video call applications were excluded.

Facility Information:

Facility Name

Pulmonary department of medical faculty Universitas Sebelas Maret

City

Surakarta

State/Province

Central Java

ZIP/Postal Code

57126

Country

Indonesia

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Pedometer Assisted Physical Activity in Individuals With COPD. A Multicenter Randomized Controlled Trial.

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