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

• Sponsor: Yusup subagio sutanto (Other)
• Overall Status: Completed
• CT.gov ID: NCT05098964
• Collaborator: (none)
• Enrollment: 180
• Location: 1
• Arms: 2
• Actual Duration (Months): 23
• Patients Per Site Per Month: 7.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease (COPD)	Device: pedometer home based rehabilitation; Other: Exercise training	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 180 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Physical Activity in COPD
• Actual Study Start Date: Feb 1, 2019
• Actual Primary Completion Date: Feb 29, 2020
• Actual Study Completion Date: Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study Group (pedometer) 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.	Device: pedometer home based rehabilitation; Home based pulmonary rehabilitation for 6 weeks using pedometer Omron HJ 321 pedometer (Omron Healthcare Co Ltd, Kyoto, Japan); Other Names: pedometer
Experimental: Control Group participants received supervised exercise training at outpatient clinics for total 18 sessions (3 weekly sessions for 6 weeks).	Other: Exercise training; Hospital based exercise training for 6 weeks

Outcome Measures

Primary Outcome Measures

1. Exercise Tolerance [Before and after program (6 weeks)]

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

Secondary Outcome Measures

1. Physical Activity [Before and after program (6 weeks)]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pulmonary department of medical faculty Universitas Sebelas Maret	Surakarta	Central Java	Indonesia	57126

Sponsors and Collaborators

• Yusup subagio sutanto

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yusup subagio sutanto, Chief of pulmonary department, Universitas Sebelas Maret
• ClinicalTrials.gov Identifier: NCT05098964
• Other Study ID Numbers: 713/IX/HREC/2018
• First Posted: Oct 29, 2021
• Last Update Posted: Oct 29, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Yusup subagio sutanto, Chief of pulmonary department, Universitas Sebelas Maret: Pulmonary rehabilitation; Tele-medicine; Exercise capacity; Dyspnoea; Quality of life
• Additional relevant MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Oct 29, 2021