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

Physical Activity in COPD

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05098964
Enrollment
180
Registered
2021-10-29
Start date
2019-02-01
Completion date
2020-12-31
Last updated
2021-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

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

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.

Interventions

DEVICEpedometer home based rehabilitation

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

OTHERExercise training

Hospital based exercise training for 6 weeks

Sponsors

Yusup subagio sutanto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Exercise ToleranceBefore and after program (6 weeks)Exercise tolerance was assessed by mean of the 6MWT according to accepted

Secondary

MeasureTime frameDescription
Physical ActivityBefore 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.

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026