Chronic Obstructive Pulmonary Disease (COPD)NCT05098964
Pedometer Assisted Physical Activity in Individuals With COPD. A Multicenter Randomized Controlled Trial.
A study testing pedometer home based rehabilitation and Exercise training in people with Chronic Obstructive Pulmonary Disease (COPD), run by Yusup subagio sutanto at 1 site in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- pedometer home based rehabilitation and Exercise training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Feb 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Pulmonary department of medical faculty Universitas Sebelas Maret
Surakarta, Central Java, 57126
About this study
Official title: Physical Activity in COPD
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.
Read the 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.
- Being tested
- pedometer home based rehabilitation, Exercise training
- Keywords
- Pulmonary rehabilitation; Tele-medicine; Exercise capacity; Dyspnoea; Quality of life
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pedometer home based rehabilitationDevice
Also called pedometer
Home based pulmonary rehabilitation for 6 weeks using pedometer Omron HJ 321 pedometer (Omron Healthcare Co Ltd, Kyoto, Japan)
Exercise trainingOther
Hospital based exercise training for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Study Group (pedometer) | Experimental | 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. Receives: Device: pedometer home based rehabilitation |
| Control Group | Experimental | participants received supervised exercise training at outpatient clinics for total 18 sessions (3 weekly sessions for 6 weeks). Receives: Other: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Tolerance
Exercise tolerance was assessed by mean of the 6MWT according to accepted
Measured: Before and after program (6 weeks)
Secondary outcomes (1)
Physical Activity
Physical activity was measured as daily steps, based on an average step count of 7 days obtained from the pedometer.
Measured: Before and after program (6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start1 Feb 2019
- Primary completion29 Feb 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yusup subagio sutanto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yusup subagio sutanto, Universitas Sebelas Maret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05098964
- Sponsor's protocol ID
- 713/IX/HREC/2018
- Status last verified
- Oct 2021
- First submitted
- 17 Oct 2021
- Last updated
- 29 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity in COPD
- ClinicalTrials.gov ID
- NCT05098964
- Acronym / sponsor ID
- 713/IX/HREC/2018
- Keywords
- Pulmonary rehabilitation; Tele-medicine; Exercise capacity; Dyspnoea; Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Yusup subagio sutantoUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 29 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group (pedometer) | Experimental | Device: pedometer home based rehabilitationParticipants 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. |
| Control Group | Experimental | Other: Exercise trainingparticipants received supervised exercise training at outpatient clinics for total 18 sessions (3 weekly sessions for 6 weeks). |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pedometer home based rehabilitationAlso: pedometerHome based pulmonary rehabilitation for 6 weeks using pedometer Omron HJ 321 pedometer (Omron Healthcare Co Ltd, Kyoto, Japan) | Device | Study Group (pedometer) |
| Exercise trainingHospital based exercise training for 6 weeks | Other | Control Group |
Primary outcome
Exercise Tolerance
Time frame: Before and after program (6 weeks)
Exercise tolerance was assessed by mean of the 6MWT according to accepted
1 secondary outcome
Physical Activity
Time frame: Before and after program (6 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pedometer home based rehabilitation and Exercise training in people with Chronic Obstructive Pulmonary Disease (COPD), run by Yusup subagio sutanto at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise Tolerance (time frame: Before and after program (6 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2021.