COPDNCT05961553
Effect of an Individual Counseling Session on Physical Activity Level of Individuals With COPD
A study testing Physical Activity Counseling session and Pulmonary Reabilitation in people with COPD, run by Polytechnic Institute of Porto at 1 site in Portugal.
Trial summary
The goal of this randomized clinical trial is to study the effect of an individual counseling session on the level of physical activity and motivation to practice physical exercise in individuals with COPD. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Physical Activity Counseling session and Pulmonary Reabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Dec 2022to 31 Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Portuguese nationality;
- Medical diagnosis of COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD 2022);
- Aged over 40 years.
Who cannot join
- underwent recent orthopedic surgeries (<3 months);
- Pregnant;
- Terminal illness diagnosis (life expectancy of less than 6 months);
- High cardiovascular risk classification for the practice of physical activity according to American College of Sports Medicine (ACSM 2018).
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Hospital Distrital da Figueira da Foz, EPE
Figueira da Foz Municipality, Coimbra District, 3094-001
About this study
Official title: Effect of an Individual Counseling Session on Physical Activity Level of Individuals With Chronic Obstructive Pulmonary Disease (COPD) - Randomized Controlled Study (RCT)
The goal of this randomized clinical trial is to study the effect of an individual counseling session on the level of physical activity and motivation to practice physical exercise in individuals with COPD. The main question[s] it aims to answer are:
- Does a counseling session improve the level of physical activity and motivation to practice physical exercise in individuals with COPD?
Participants will perform a respiratory rehabilitation program (Control Group, CG) and a respiratory rehabilitation program and the counseling session (Experimental Group, EG).
Researchers will compare EG to CG to see if there is any difference in physical activity level and motivation to exercise between groups.
- Conditions
- COPD
- Being tested
- Physical Activity Counseling session, Pulmonary Reabilitation
- Keywords
- COPD, Pulmonary Rehabilitation, Physical Activity, Counseiling Session, Exercise
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity Counseling sessionBehavioural
The counseling session on physical activity was carried out individually, six weeks after starting the respiratory rehabilitation program, with an average duration of 30 minutes, based on the guidelines of the Living Well with COPD program. The main objective of the session was: to help the participant and family members to increase physical activity levels and their integration in the long term and as secondary objectives; reinforce the importance and benefits of physical activity in the management of the health condition/symptoms; plan daily/weekly moments of physical activity; define daily goals (physical activity time/sitting time) attainable for each participant; integrate family members/companions into the user's physical activity plan; clarify doubts of the user/relative about the theme.
Pulmonary ReabilitationOther
The program comprises a hospital group exercise program, twice a week, on alternate days, for 1h30 to 2h, each session.
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity Counseling + Pulmonary Rehabilitation | Experimental | The counseling session on physical activity was carried out individually, six weeks after starting the respiratory rehabilitation program, with an average duration of 30 minutes, based on the guidelines of the Living Well with COPD program. The main objective of the session was: to help the participant and family members to increase physical activity levels and their integration in the long term and as secondary objectives; reinforce the importance and benefits of physical activity in the management of the health condition/symptoms; plan daily/weekly moments of physical activity; define daily goals (physical activity time/sitting time) attainable for each participant; integrate family members/companions into the user's physical activity plan; clarify doubts of the user/relative about the theme. Receives: Behavioral: Physical Activity Counseling session; Other: Pulmonary Reabilitation |
| Pulmonary Rehabilitation | Active comparator | The program comprises a hospital group exercise program, twice a week, on alternate days, for 1h30 to 2h, each session, which included: monitoring of vital signs, peripheral oxygen saturation (SpO2), subjective perception of exertion (RPE), dyspnea and body mass; warm-up phase (10min), with ventilatory control and low-intensity upper and lower limb exercises; continuous aerobic training phase, performed on a treadmill, static cycle ergometer and/or arm ergometer (30-45min), at 60-80% of the maximum Cardiopulmonary Exercise Test load; strength training phase, with free weights, machines (10-20min), at 50-80% of the Maximum Repetition (RM), (8-12 repetitions), 1-2 sets, 8-10 exercises ( upper limbs, trunk and lower limbs); cooling phase (5-10min), with 5 to 8 relaxation, stretching and ventilatory control exercises. The progression of training loads is carried out according to RPE and dyspnea, safeguarding SpO2 values above 88-90% and Heart Rate below the maximum defined for training. Receives: Other: Pulmonary Reabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Daily Steps
quantitative variable met through the daily average of the steps, using accelerometer data.
Measured: 7 days
Light Physical Activity
quantitative variable evaluated with the accelerometer, measured in minutes.
Measured: 7 days
Moderate Physical Activity
quantitative variable evaluated with the accelerometer, measured in minutes.
Measured: 7 days
Vigorous Physical Activity
quantitative variable evaluated with the accelerometer, measured in minutes.
Measured: 7 days
Sedentary Activity
quantitative variable evaluated with the accelerometer, measured in minutes.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Dec 2022
- Primary completion30 Sep 2023
- Study completion31 Dec 2023
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 COPDStudies 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
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polytechnic Institute of Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tiago Miguel dos Santos Pastilha, Polytechnic Institute of Porto
- Investigators
- Tiago Pastilha, PT, Principal investigator, Escola Superior de SaúdeAna Alexandrino, PhD, Study director, Escola Superior de SaúdeSusana Vale, PhD, Study director, Escola Superior de EducaçãoRui Macedo, PhD, Study director, Escola Superior de Saúde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05961553
- Sponsor's protocol ID
- 16.OBS.2020
- Status last verified
- Feb 2025
- First submitted
- 16 Jul 2023
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pastilha T, Macedo R, Vale S, Santos R, Martins V, Borges J, Sebastiao V, Alexandrino AS. Effects of Individualized Physical Activity Counseling Added to Pulmonary Rehabilitation on Physical Activity, Sedentary Behavior, and Exercise Motivation in Individuals With COPD: A Randomized Controlled Trial. J Cardiopulm Rehabil Prev. 2026 Sep 1;46(5):330-340. doi: 10.1097/HCR.0000000000001027. Epub 2026 Mar 17.
PubMed 41843815
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Individual Counseling Session on Physical Activity Level of Individuals With Chronic Obstructive Pulmonary Disease (COPD) - Randomized Controlled Study (RCT)
- ClinicalTrials.gov ID
- NCT05961553
- Acronym / sponsor ID
- 16.OBS.2020
- Conditions
- COPD
- Keywords
- COPD, Pulmonary Rehabilitation, Physical Activity, Counseiling Session, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Polytechnic Institute of PortoUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 27 Jul 2023 (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 goal of this randomized clinical trial is to study the effect of an individual counseling session on the level of physical activity and motivation to practice physical exercise in individuals with COPD. The main question[s] it aims to answer are:
- Does a counseling session improve the level of physical activity and motivation to practice physical exercise in individuals with COPD?
Participants will perform a respiratory rehabilitation program (Control Group, CG) and a respiratory rehabilitation program and the counseling session (Experimental Group, EG).
Researchers will compare EG to CG to see if there is any difference in physical activity level and motivation to exercise between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Activity Counseling + Pulmonary Rehabilitation | Experimental | Behavioral: Physical Activity Counseling session, Other: Pulmonary ReabilitationThe counseling session on physical activity was carried out individually, six weeks after starting the respiratory rehabilitation program, with an average duration of 30 minutes, based on the guidelines of the Living Well with COPD program. The main objective of the session was: to help the participant and family members to increase physical activity levels and their integration in the long term and as secondary objectives; reinforce the importance and benefits of physical activity in the management of the health condition/symptoms; plan daily/weekly moments of physical activity; define daily goals (physical activity time/sitting time) attainable for each participant; integrate family members/companions into the user's physical activity plan; clarify doubts of the user/relative about the theme. |
| Pulmonary Rehabilitation | Active comparator | Other: Pulmonary ReabilitationThe program comprises a hospital group exercise program, twice a week, on alternate days, for 1h30 to 2h, each session, which included: monitoring of vital signs, peripheral oxygen saturation (SpO2), subjective perception of exertion (RPE), dyspnea and body mass; warm-up phase (10min), with ventilatory control and low-intensity upper and lower limb exercises; continuous aerobic training phase, performed on a treadmill, static cycle ergometer and/or arm ergometer (30-45min), at 60-80% of the maximum Cardiopulmonary Exercise Test load; strength training phase, with free weights, machines (10-20min), at 50-80% of the Maximum Repetition (RM), (8-12 repetitions), 1-2 sets, 8-10 exercises ( upper limbs, trunk and lower limbs); cooling phase (5-10min), with 5 to 8 relaxation, stretching and ventilatory control exercises. The progression of training loads is carried out according to RPE and dyspnea, safeguarding SpO2 values above 88-90% and Heart Rate below the maximum defined for training. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Portuguese nationality;
- Medical diagnosis of COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD 2022);
- Aged over 40 years.
Key exclusion criteria (4 listed)
- underwent recent orthopedic surgeries (<3 months);
- Pregnant;
- Terminal illness diagnosis (life expectancy of less than 6 months);
- High cardiovascular risk classification for the practice of physical activity according to American College of Sports Medicine (ACSM 2018).
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 |
|---|---|---|
| Physical Activity Counseling sessionThe counseling session on physical activity was carried out individually, six weeks after starting the respiratory rehabilitation program, with an average duration of 30 minutes, based on the guidelines of the Living Well with COPD program. The main objective of the session was: to help the participant and family members to increase physical activity levels and their integration in the long term and as secondary objectives; reinforce the importance and benefits of physical activity in the management of the health condition/symptoms; plan daily/weekly moments of physical activity; define daily goals (physical activity time/sitting time) attainable for each participant; integrate family members/companions into the user's physical activity plan; clarify doubts of the user/relative about the theme. | Behavioural | Physical Activity Counseling + Pulmonary Rehabilitation |
| Pulmonary ReabilitationThe program comprises a hospital group exercise program, twice a week, on alternate days, for 1h30 to 2h, each session. | Other | Physical Activity Counseling + Pulmonary Rehabilitation, Pulmonary Rehabilitation |
Primary outcome
Average Daily Steps
Time frame: 7 days
quantitative variable met through the daily average of the steps, using accelerometer data.
Light Physical Activity
Time frame: 7 days
quantitative variable evaluated with the accelerometer, measured in minutes.
Moderate Physical Activity
Time frame: 7 days
quantitative variable evaluated with the accelerometer, measured in minutes.
Vigorous Physical Activity
Time frame: 7 days
quantitative variable evaluated with the accelerometer, measured in minutes.
Sedentary Activity
Time frame: 7 days
quantitative variable evaluated with the accelerometer, measured in minutes.
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 12 Feb 2025.
- Derived from this study: PubMed 41843815Pastilha T, Macedo R, Vale S, Santos R, Martins V, Borges J, Sebastiao V, Alexandrino AS. Effects of Individualized Physical Activity Counseling Added to Pulmonary Rehabilitation on Physical Activity, Sedentary Behavior, and Exercise Motivation in Individuals With COPD: A Randomized Controlled Trial. J Cardiopulm Rehabil Prev. 2026 Sep 1;46(5):330-340. doi: 10.1097/HCR.0000000000001027. Epub 2026 Mar 17.
- Individual participant dataSharing planned: No
Related trials for COPD
Active, not recruiting
Influence of FreeO2 on Percentage of Time Within Oxygen Saturation Target Using Noninvasive Ventilation (NIV) and Continuous Positive Airway Pressure (CPAP) for Patients Admitted for AECOPD or Bariatric Surgery
COPD Exacerbation, Oxygen Toxicity
Recruiting
Comparison of Several Oxygenation Targets With Different Oxygen Interfaces - Impact on Oxygen Flow Rates
Oxygen Toxicity, COPD Bronchitis
Active, not recruitingPhase 2
Inhaled Treprostinil for Dyspnea and Exercise Intolerance in Mild COPD
COPD (Chronic Obstructive Pulmonary Disease)
Recruiting
Evaluating the Safety and Efficacy of dNerva Lung Denervation System in Patients With COPD
COPD, Chronic Obstructive Pulmonary Disease
RecruitingPhase 1
Impact of Eradication Therapy on Helicobacter Pylori Infection With Chronic Obstructive Pulmonary Disease:
Chronic Obstructive Pulmonary Disease (COPD), With Poitive H Pylori
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.
Tiago Pastilha, PT principal investigator
Escola Superior de Saúde
Ana Alexandrino, PhD study director
Escola Superior de Saúde
Susana Vale, PhD study director
Escola Superior de Educação
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity Counseling session and Pulmonary Reabilitation in people with COPD, run by Polytechnic Institute of Porto 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 3 inclusion and 4 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 12 Feb 2025. 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?
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?
Average Daily Steps (time frame: 7 days). The study lists 5 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 NCT05961553, 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 12 Feb 2025; AzTrials last refreshed its copy on 6 Nov 2026.