Chronic Obstructive Pulmonary DiseaseRehab2lifeNCT05315505
Effectiveness of a Home-based Pulmonary Rehabilitation Program in COPD Patients
A study testing Maintenance programme in people with Chronic Obstructive Pulmonary Disease and Pulmonary Rehabilitation, run by Unidade Local de Saúde de Matosinhos, EPE at 1 site in Portugal.
Trial summary
The study aims to develop and test the effectiveness of a new home-based pulmonary rehabilitation program comprising two distinct phases, the first in which an 8-week respiratory rehabilitation program is carried out the second in which a maintenance pulmonary rehabilitation program is carried out. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Pulmonary Rehabilitation
- What is being tested?
- Maintenance programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 sitePortugal
- Study dates
- 9 May 2022to Apr 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD diagnose with B or E characterization according to GOLD criteria;
- Residence in the area covered by the institution where the study is carried out
Who cannot join
- Frequency of a PR programme in the previous six months
- COPD exacerbation for less than one week;
- Presence of unstable comorbidities (List of predetermined diagnoses that constitute absolute exclusion criteria);
- Presence of comorbidities that constitute relative exclusion criteria through a medical evaluation.
- Score of the Clinical Frailty Scale 2.0 above six or above five in case of not having a responsible caregiver and living alone
- SpO2 below 85% in the 6-minute walk test
Trial locations and contacts
1 site in 1 country.
Miguel Padilha, PhD contact
Portugal1 site, 1 recruiting
- Recruiting
Unidade Local de Saúde de Matosinhos
Matosinhos Municipality, Porto District, 4450
Liliana Silva, MSc, +351917556931, enf.lilianasilva@gmail.com
Liliana Silva, MSc, liliana.silva@ulsm.min-saude.pt
About this study
The study aims to develop and test the effectiveness of a new home-based pulmonary rehabilitation program comprising two distinct phases, the first in which an 8-week respiratory rehabilitation program is carried out the second in which a maintenance pulmonary rehabilitation program is carried out.
- Being tested
- Maintenance programme, Usual Care
- Keywords
- COPD, Pulmonary rehabilitation, Maintenance pulmonary rehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maintenance programmeOther
Also called Physical exercise, Behaviour change, Self-management
Continuous educational support, exercise training, behaviour change intervention, and self-management.
Maintenance home-based pulmonary rehabilitation programme for ten months with alternate supervision
Usual CareOther
No maintenance programme, and the patient has the usual follow-up and medical appointments
| Study group | Role | What they receive |
|---|---|---|
| Maintenance | Experimental | Participants will undergo an initial home-based pulmonary rehabilitation program for eight weeks.
At the end of the eight weeks, the participants will be randomly assigned into two groups, one receiving the maintenance pulmonary rehabilitation program and the other receiving the usual care.
The maintenance arm will receive home visits for supervised physical exercise and progressively alternated with phone calls to motivation and feedback Receives: Other: Maintenance programme |
| control | Active comparator | Participants will undergo an initial home-based pulmonary rehabilitation program for eight weeks.
At the end of the eight weeks, the participants will be randomly assigned into two groups, one receiving the maintenance pulmonary rehabilitation program and the other receiving the usual care.
The control group will have access to the usual follow. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance in meters covered over a time of 6 minutes 0
Distance in meters covered over a time of 6 minutes 0 measured with the 6 minute walking test (6MWT) - The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance in meters covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Measured: Baseline
Distance in meters covered over a time of 6 minutes 1
Distance in meters covered over a time of 6 minutes 1 measured with the 6 minute walking test (6MWT) - The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance in meters covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Measured: 8 weeks
Distance in meters covered over a time of 6 minutes 2
Distance in meters covered over a time of 6 minutes 2 measured with the 6 minute walking test (6MWT) - The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance in meters covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Measured: 7 months
Distance in meters covered over a time of 6 minutes 3
Distance in meters covered over a time of 6 minutes 3 measured with the 6 minute walking test (6MWT) - The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance in meters covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Measured: 12 months
Secondary outcomes (28)
Dyspnoea 0
modified Medical Research Council dyspnoea scale (mMRC) - Range from 1 to 5, The higher the score, the worst the dyspnoea
Measured: Baseline
Dyspnoea 1
modified Medical Research Council dyspnoea scale (mMRC) - Range from 1 to 5, The higher the score, the worst the dyspnoea
Measured: 8 weeks
Dyspnoea 2
modified Medical Research Council dyspnoea scale (mMRC) - Range from 1 to 5, The higher the score, the worst the dyspnoea
Measured: 7 months
Dyspnoea 3
modified Medical Research Council dyspnoea scale (mMRC) - Range from 1 to 5, The higher the score, the worst the dyspnoea
Measured: 12 months
Health-Related Quality of Life 0
European quality of life-5 dimensions (EQ5D)
Measured: Baseline
Health-Related Quality of Life 1
European quality of life-5 dimensions (EQ5D)
Measured: 8 weeks
Health-Related Quality of Life 2
European quality of life-5 dimensions (EQ5D)
Measured: 7 months
Health-Related Quality of Life 3
European quality of life-5 dimensions (EQ5D)
Measured: 12 months
Number of emergency department visits due to COPD exacerbation 0
Number of exacerbations (accessing to emergency department)
Measured: Baseline
Number of emergency department visits due to COPD exacerbation 1
Number of exacerbations (accessing to emergency department)
Measured: 8 weeks
Number of emergency department visits due to COPD exacerbation 2
Number of exacerbations (accessing to emergency department)
Measured: 7 months
Number of emergency department visits due to COPD exacerbation 3
Number of exacerbations (accessing to emergency department)
Measured: 12 months
COPD symptom control 0
COPD Assessment Test - Range from 0 to 40. The higher the score, the worst the clinical control
Measured: Baseline
COPD symptom control 1
COPD Assessment Test - Range from 0 to 40. The higher the score, the worst the clinical control
Measured: 8 weeks
COPD symptom control 2
COPD Assessment Test - Range from 0 to 40. The higher the score, the worst the clinical control
Measured: 7 months
COPD symptom control 3
COPD Assessment Test - Range from 0 to 40. The higher the score, the worst the clinical control
Measured: 12 months
Anxiety and Depression 0
Hospital Anxiety and Depression Scale (HADS) - HADS is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score >8 denotes anxiety or depression. HADS scoring was done before and after low-vision consultation to see whether there was a change in the scoring
Measured: Baseline
Anxiety and Depression 1
Hospital Anxiety and Depression Scale (HADS) - HADS is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score >8 denotes anxiety or depression. HADS scoring was done before and after low-vision consultation to see whether there was a change in the scoring
Measured: 8 weeks
Anxiety and Depression 2
Hospital Anxiety and Depression Scale (HADS) - HADS is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score >8 denotes anxiety or depression. HADS scoring was done before and after low-vision consultation to see whether there was a change in the scoring
Measured: 7 months
Anxiety and Depression 3
Hospital Anxiety and Depression Scale (HADS) - HADS is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score >8 denotes anxiety or depression. HADS scoring was done before and after low-vision consultation to see whether there was a change in the scoring
Measured: 12 months
Physical activity 0
Counting steps per day with the pedometer Yamax EX510
Measured: Baseline
Physical activity 1
Counting steps per day with the pedometer Yamax EX510
Measured: 8 weeks
Physical activity 2
Counting steps per day with the pedometer Yamax EX510
Measured: 7 months
Physical activity 3
Counting steps per day with the pedometer Yamax EX510
Measured: 12 months
Functional capacity 0
Number of times per minute an individual is able to stand up and sit down on a chair standardised for height
Measured: Baseline
Functional capacity 1
Number of times per minute an individual is able to stand up and sit down on a chair standardised for height
Measured: 8 weeks
Functional capacity 2
Number of times per minute an individual is able to stand up and sit down on a chair standardised for height
Measured: 7 months
Functional capacity 3
Number of times per minute an individual is able to stand up and sit down on a chair standardised for height
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start9 May 2022
- Primary completionDec 2023 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Parallel groups
- Model description
- Randomization will be performed after verifying the inclusion and exclusion criteria in the study and the informed, free and informed consent of the individuals. Randomization will be carried out by permuted blocks of 4 to guarantee the same number of participants in each group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unidade Local de Saúde de Matosinhos, EPE
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liliana Silva, Unidade Local de Saúde de Matosinhos, EPE
- Investigators
- Liliana Silva, MSc, Principal investigator, Matosinhos Local Health Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05315505
- Sponsor's protocol ID
- 136/CES/JAS
- Acronym
- Rehab2life
- Status last verified
- Aug 2023
- First submitted
- 21 Mar 2022
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Silva L, Maricoto T, Mota A, Lemos L, Santos M, Cunha H, Azevedo I, Berger-Estilita J, Costa P, Padilha JM. Effectiveness of a home-based pulmonary rehabilitation maintenance programme: the Rehab2Life study protocol. BMC Nurs. 2024 May 21;23(1):338. doi: 10.1186/s12912-024-01999-6.
PubMed 38773568
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Home-based Pulmonary Rehabilitation Program in COPD Patients
- ClinicalTrials.gov ID
- NCT05315505
- Acronym / sponsor ID
- Rehab2life / 136/CES/JAS
- Keywords
- COPD, Pulmonary rehabilitation, Maintenance pulmonary rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Unidade Local de Saúde de Matosinhos, EPEUniversity, hospital or other
- Study start
- 9 May 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 7 Apr 2022 (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.
The study aims to develop and test the effectiveness of a new home-based pulmonary rehabilitation program comprising two distinct phases, the first in which an 8-week respiratory rehabilitation program is carried out the second in which a maintenance pulmonary rehabilitation program is carried out.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomization will be performed after verifying the inclusion and exclusion criteria in the study and the informed, free and informed consent of the individuals. Randomization will be carried out by permuted blocks of 4 to guarantee the same number of participants in each group.
| Arm | Type | Receives |
|---|---|---|
| Maintenance | Experimental | Other: Maintenance programmeParticipants will undergo an initial home-based pulmonary rehabilitation program for eight weeks. At the end of the eight weeks, the participants will be randomly assigned into two groups, one receiving the maintenance pulmonary rehabilitation program and the other receiving the usual care. The maintenance arm will receive home visits for supervised physical exercise and progressively alternated with phone calls to motivation and feedback |
| control | Active comparator | Other: Usual CareParticipants will undergo an initial home-based pulmonary rehabilitation program for eight weeks. At the end of the eight weeks, the participants will be randomly assigned into two groups, one receiving the maintenance pulmonary rehabilitation program and the other receiving the usual care. The control group will have access to the usual follow. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- COPD diagnose with B or E characterization according to GOLD criteria;
- Residence in the area covered by the institution where the study is carried out
Key exclusion criteria (6 listed)
- Frequency of a PR programme in the previous six months
- COPD exacerbation for less than one week;
- Presence of unstable comorbidities (List of predetermined diagnoses that constitute absolute exclusion criteria);
- Presence of comorbidities that constitute relative exclusion criteria through a medical evaluation.
- Score of the Clinical Frailty Scale 2.0 above six or above five in case of not having a responsible caregiver and living alone
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 |
|---|---|---|
| Maintenance programmeAlso: Physical exercise, Behaviour change, Self-managementContinuous educational support, exercise training, behaviour change intervention, and self-management. Maintenance home-based pulmonary rehabilitation programme for ten months with alternate supervision | Other | Maintenance |
| Usual CareNo maintenance programme, and the patient has the usual follow-up and medical appointments | Other | control |
Primary outcome
Distance in meters covered over a time of 6 minutes 0
Time frame: Baseline
Distance in meters covered over a time of 6 minutes 0 measured with the 6 minute walking test (6MWT) - The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance in meters covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Distance in meters covered over a time of 6 minutes 1
Time frame: 8 weeks
Distance in meters covered over a time of 6 minutes 1 measured with the 6 minute walking test (6MWT) - The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance in meters covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Distance in meters covered over a time of 6 minutes 2
Time frame: 7 months
Distance in meters covered over a time of 6 minutes 2 measured with the 6 minute walking test (6MWT) - The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance in meters covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Distance in meters covered over a time of 6 minutes 3
Time frame: 12 months
Distance in meters covered over a time of 6 minutes 3 measured with the 6 minute walking test (6MWT) - The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance in meters covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
28 secondary outcomes
Dyspnoea 0
Time frame: Baseline
Dyspnoea 1
Time frame: 8 weeks
Dyspnoea 2
Time frame: 7 months
Dyspnoea 3
Time frame: 12 months
Health-Related Quality of Life 0
Time frame: Baseline
Health-Related Quality of Life 1
Time frame: 8 weeks
Health-Related Quality of Life 2
Time frame: 7 months
Health-Related Quality of Life 3
Time frame: 12 months
Number of emergency department visits due to COPD exacerbation 0
Time frame: Baseline
Number of emergency department visits due to COPD exacerbation 1
Time frame: 8 weeks
Number of emergency department visits due to COPD exacerbation 2
Time frame: 7 months
Number of emergency department visits due to COPD exacerbation 3
Time frame: 12 months
COPD symptom control 0
Time frame: Baseline
COPD symptom control 1
Time frame: 8 weeks
COPD symptom control 2
Time frame: 7 months
COPD symptom control 3
Time frame: 12 months
Anxiety and Depression 0
Time frame: Baseline
Anxiety and Depression 1
Time frame: 8 weeks
Anxiety and Depression 2
Time frame: 7 months
Anxiety and Depression 3
Time frame: 12 months
Physical activity 0
Time frame: Baseline
Physical activity 1
Time frame: 8 weeks
Physical activity 2
Time frame: 7 months
Physical activity 3
Time frame: 12 months
Functional capacity 0
Time frame: Baseline
Functional capacity 1
Time frame: 8 weeks
Functional capacity 2
Time frame: 7 months
Functional capacity 3
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Derived from this study: PubMed 38773568Silva L, Maricoto T, Mota A, Lemos L, Santos M, Cunha H, Azevedo I, Berger-Estilita J, Costa P, Padilha JM. Effectiveness of a home-based pulmonary rehabilitation maintenance programme: the Rehab2Life study protocol. BMC Nurs. 2024 May 21;23(1):338. doi: 10.1186/s12912-024-01999-6.
- Individual participant dataSharing planned: No
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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.
Miguel Padilha, PhD contact
Liliana Silva, MSc principal investigator
Matosinhos Local Health Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maintenance programme in people with Chronic Obstructive Pulmonary Disease and Pulmonary Rehabilitation, run by Unidade Local de Saúde de Matosinhos, EPE at 1 site in Portugal.
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 6 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: status not confirmed, as of the sponsor's last update on 24 Aug 2023. 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 Portugal. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liliana Silva, MSc (+351917556931, enf.lilianasilva@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance in meters covered over a time of 6 minutes 0 (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05315505, which also lists 1 linked publication.
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 24 Aug 2023.