Chronic Obstructive Pulmonary Disease (COPD)FITMENCT07792642
FITME Study: Formulating Individualised Exercise Prescription in Chronic Obstructive Pulmonary Disease
A study testing Pulmonary rehabilitation programme in people with Chronic Obstructive Pulmonary Disease (COPD), run by Aveiro University at 1 site in Portugal.
Trial summary
This randomised controlled trial aims to: i) compare the power output at the first metabolic threshold (WMT1) between the MT1 and the six-minute walking test (6MWT)-based cardiorespiratory exercise prescriptions in chronic obstructive pulmonary disease (COPD); ii) compare exercise adherence, peripheral muscle… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Pulmonary rehabilitation programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Sep 2026to 31 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Clinical diagnosis of COPD;
- Complete a maximal CPET with MT1 identification.
Who cannot join
- Presence of unstable or significant conditions (e.g. musculoskeletal, neurological, cardiovascular, neoplasia or immunological) that renders the participation in the pulmonary rehabilitation program infeasible;
- Participated in pulmonary rehabilitation in the last 12 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site
University of Aveiro
Aveiro
Alda S Marques, PhD, 00351 234 372 462, amarques@ua.pt
Alda S Marques, PhD
About this study
This randomised controlled trial aims to: i) compare the power output at the first metabolic threshold (WMT1) between the MT1 and the six-minute walking test (6MWT)-based cardiorespiratory exercise prescriptions in chronic obstructive pulmonary disease (COPD); ii) compare exercise adherence, peripheral muscle strength, health-related quality of life, dyspnoea, fatigue, disease impact and emotional status between MT1 and 6MWT-based exercise prescriptions.
Patients will be recruited via the pulmonology services from Unidade Local de Saúde do Baixo Mondego and Unidade Local de Saúde de Aveiro.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is a progressive and impactful disease characterised by chronic ariflow. Beyond its primary respiratory symptoms (i.e. dyspnoea, sputum production, cough, and frequent exacerbations), COPD is often accompanied by systemic, extrapulmonary manifestations such as skeletal muscle dysfunction.
Exercise is a structured, purposeful subset of physical activity designed to improve or maintain one or more components of physical fitness and health benefits. Within the management of COPD, conventionally delivered through pulmonary rehabilitation programme, exercise training triggers crucial extrapulmonary adaptations. By improving peripheral muscle function and cardiovascular efficiency, it reduces the overall load on the pulmonary system, ultimately improving symptoms, preventing hospitalizations, and halting clinical deterioration. To achieve these adaptations, a minimum threshold of external load (typically moderate-intensity exercise) should be implemented. International guidelines and expert consensus recommend healthcare professionals to prescribe cardiorespiratory exercise based on field tests (i.e. 6MWT). However, as a submaximal assessment, the 6MWT typically elicits submaximal functional responses, which distinctively differ from the peak physiological demands captured during a cardiopulmonary exercise test (CPET). Recent evidence highlights the first metabolic threshold (MT1) as an optimal benchmark for prescribing cardiorespiratory exercise. This physiological marker establishes the transition from light to moderate exercise intensity and can be accurately determined via a CPET.
Sticking to traditional exercise prescription models can cause imprecise monitoring and dosing, which may compromise patient safety, increase frustration, and lower adherence. This ongoing uncertainty in prescribing cardiorespiratory exercise for people with COPD can impair pulmonary rehabilitation outcomes and potentially lead to flawed healthcare policy decisions.
Therefore, the primary aim of this study is to compare exercise prescription based on MT1 and on the 6MWT for improving power output at MT1 in people with COPD. Secondary aim is to compare exercise adherence, peripheral muscle strength, health-related quality of life, dyspnoea, fatigue, disease impact, and emotional status between MT1 and 6MWT-based prescriptions.
This study will be conducted at Unidade Local de Saúde do Baixo Mondego, Figueira da Foz, Unidade Local de Saúde da Região de Aveiro, and at the Laboratory of Research and Respiratory Rehabilitation of the School of Health Sciences of the University of Aveiro (LAB3R-ESSUA).
Patients with a formal diagnose of stable COPD and a maximal CPET with MT1 determination will be included. Individuals who have unstable or severe comorbidities (e.g., musculoskeletal, neurological, cardiovascular, neoplastic, or immunological) that prevent participation in pulmonary rehabilitation, as well as those who have completed or attended a pulmonary rehabilitation program within the past 12 months will be excluded.
Sociodemographic and general clinical data will be collected. Instruments assessing health-related quality of life, dyspnoea, fatigue, disease impact, emotional status, and cough will be applied.
Sample size calculation was performed using G*Power version 3.1 (Heinrich Heine University Düsseldorf, Germany).
A sample size calculation was computed using G*Power3.1.9.6 for the within-between interaction of a mixed ANOVA with two groups and 2 assessments (baseline and post pulmonary rehabilitation) of the primary outcome. The sample size was estimated considering an alpha=0.05, power=0.80, repeated measures correlation=0.5, nonsphericity correction=1, and a moderate effect, partial eta squared (η2) of 0.06, the required sample size was 34 participants. As the anticipated dropout rate was 25% a final anticipated sample size was 46 participants (23/group).
- Being tested
- Pulmonary rehabilitation programme
- Keywords
- chronic obstructive pulmonary disease, ventilatory threshold, gas exchange threshold, physical activity
- 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.
Pulmonary rehabilitation programmeOther
Participants will undergo a supervised, in-person pulmonary rehabilitation programme lasting for twelve weeks, twice a week. The intervention comprises cardiorespiratory exercise training, conducted on either a treadmill or a cycle ergometer. Exercise intensity will be individually prescribed based on the power output registered at the first metabolic threshold, during a baseline cardiopulmonary exercise test. For treadmill exercise prescription, guideline-based estimation equations will be used to estimate treadmill velocity based on the oxygen uptake obtained in the first metabolic threshold. Resistance training will be provided in the same sessions as internationally recommended. Progress will occur on weekly basis, according to symptoms. Education and psychosocial support will also be provided once every other week. All sessions will range from 60-90 minutes.
Pulmonary rehabilitation programmeOther
Standard of care (pulmonary rehabilitation programme featuring six-minute walking test-derived cardiorespiratory exercise prescription).
| Study group | Role | What they receive |
|---|---|---|
| Metabolic Threshold-based exercise intensity prescription | Experimental | Not described Receives: Other: Pulmonary rehabilitation programme |
| Six-minute walking test-based exercise intensity prescription | Active comparator | Not described Receives: Other: Pulmonary rehabilitation programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise capacity - Power output at first metabolic threshold
Power output at first metabolic threshold will be measured during a cardiopulmonary exercise test (watts).
Measured: From baseline (pre-intervention) to the end of the pulmonary rehabilitation programme (12 weeks)
Secondary outcomes (11)
Exercise capacity - Peak power output
Peak power output will be measured during a cardiopulmonary exercise test (watts).
Measured: From baseline (pre-intervention) to the end of the pulmonary rehabilitation programme (12 weeks)
Exercise capacity - Six-Minute Walk Test (6MWT)
6MWT is a submaximal exercise test and is commonly used to assess functional status. It is a valid and reliable measure in COPD. It will be used as a secondary measure for exercise capacity.
Measured: From baseline (pre-intervention) to the end of the pulmonary rehabilitation programme (12 weeks)
Cardiorespiratory fitness - Maximum oxygen uptake
Maximum oxygen uptake (mL/Kg/min) is considered a key indicator of exercise tolerance and an important predictor of longevity. It is typically assessed during cardiopulmonary exercise testing and is characterized by a plateau in oxygen uptake despite a continued increase in external power output.
Measured: From baseline (pre-intervention) to the end of the pulmonary rehabilitation programme (12 weeks)
Handgrip strength
Handgrip strength will be measured with a dynamometer (kg).
Measured: From baseline (pre-intervention) to the end of the pulmonary rehabilitation programme (12 weeks)
Quadriceps Maximum Voluntary Strength (QMVS)
QMVS will be measured using a handheld dynamometer (kilogram/force).
Measured: From baseline (pre-intervention) to the end of the pulmonary rehabilitation programme (12 weeks)
One-Minute Sit-To-Stand (1min-STS)
The 1min-STS will be used to assess functional capacity. The maximum number of repetitions completed in 1 minute while sitting and standing on a chair will be counted.
Measured: From baseline (pre-intervention) to the end of the pulmonary rehabilitation programme (12 weeks)
Disease impact - Chronic Airways Assessment Test (CAAT)
CAAT assesses diseases' impact, presenting 8 items related to respiratory symptoms (cough, chest symptoms and impacts on well-being and day-to-day, related to dyspnoea, activity limitation, confidence to leave home, sleep and energy level), classified from 0 to 5. The total score is calculated by adding the score of the 8 items, ranging from 0 to 40 points, with a higher score corresponding to a greater impact of the disease. The total score can be divided into 4 levels: 1) low, 2) moderate, 3) high and 4) very high impact. The CAAT proved to be valid and reliable for people with COPD.
Measured: From baseline (pre-intervention) to the end of the pulmonary rehabilitation programme (12 weeks)
Emotional Status - Hospital Anxiety and Depression Scale (HADS)
HADS was developed with the aim of providing health professionals with a reliable, valid and easy-to-use measure to identify and quantify the level of depression and anxiety. It consists of two subscales, which are scored separately: one for anxiety (seven items) and one for depression (seven items). Each item is scored from 0 to 3 points, so each subscale varies between 0 and 21 points. Scores between 0 and 7 are considered "normal", between 8 and 10 "light", between 11 and 14 "moderate", and between 15 and 21 "severe" levels of anxiety/depression.
Measured: From baseline (pre-intervention) to the end of the pulmonary rehabilitation programme (12 weeks)
Dyspnoea severity - Modified Medical Research Council Dyspnoea Questionnaire (mMRC)
The mMRC is a validated 5-point Likert scale used to assess dyspnoea severity. Scores range from 0 ("dyspnoea only with strenuous exercise") to 4 ("too dyspnoeic to leave the house or breathless when dressing").
Measured: From baseline (pre-intervention) to the end of the pulmonary rehabilitation programme (12 weeks)
Health-Related Quality of Life - Saint-George's Respiratory Questionnaire (SGRQ)
SGRQ will be used to assess Health-Related quality of life. The SGRQ is a comprehensive well-established 50-item questionnaire to measure health status in patients with COPD. Scores can be provided for each domain (symptoms, activities and impact) and as a total score, ranging from 0 (no impairment) to 100 (worst possible health status).
Measured: From baseline (pre-intervention) to the end of the pulmonary rehabilitation programme (12 weeks)
Fatigue severity - Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-FS)
FACIT-FS assesses fatigue where a higher score translates into lower fatigue. This scale is commonly used in the COPD population to assess fatigue, presenting good reliability and feasibility.
Measured: From baseline (pre-intervention) to the end of the pulmonary rehabilitation programme (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aveiro University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alda Sofia Pires de Dias Marques, Aveiro University
- Investigators
- Alda S Marques, PhD, Principal investigator, School of Health Sciences of the University of Aveiro (ESSUA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07792642
- Sponsor's protocol ID
- 2025.04991.BDANA
- Other IDs
- 2025
- Acronym
- FITME
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hill K, Jenkins SC, Cecins N, Philippe DL, Hillman DR, Eastwood PR. Estimating maximum work rate during incremental cycle ergometry testing from six-minute walk distance in patients with chronic obstructive pulmonary disease. Arch Phys Med Rehabil. 2008 Sep;89(9):1782-7. doi: 10.1016/j.apmr.2008.01.020.
PubMed 18760164Hansen H, Bieler T, Beyer N, Kallemose T, Wilcke JT, Ostergaard LM, Frost Andeassen H, Martinez G, Lavesen M, Frolich A, Godtfredsen NS. Supervised pulmonary tele-rehabilitation versus pulmonary rehabilitation in severe COPD: a randomised multicentre trial. Thorax. 2020 May;75(5):413-421. doi: 10.1136/thoraxjnl-2019-214246. Epub 2020 Mar 30.
PubMed 32229541Harvey-Dunstan TC, Baldwin MM, Tal-Singer R, Allinder M, Polkey MI, Hamilton A, Richardson M, Edwards SA, Steiner MC, Morgan MD, Singh SJ; COPD/MAP Consortium. The Responsiveness of Exercise Tests in COPD: A Randomized Controlled Trial. Chest. 2025 Jan;167(1):98-111. doi: 10.1016/j.chest.2024.05.051. Epub 2024 Aug 21.
PubMed 39173827Nie S, Wang L, Ma S, Sun H. Impact of silicone midline catheter tip location on catheter-related complications and indwelling duration: results from a multicentre randomised clinical trial in China. BMJ Open. 2025 Mar 12;15(3):e086717. doi: 10.1136/bmjopen-2024-086717.
PubMed 40074277Radtke T, Crook S, Kaltsakas G, Louvaris Z, Berton D, Urquhart DS, Kampouras A, Rabinovich RA, Verges S, Kontopidis D, Boyd J, Tonia T, Langer D, De Brandt J, Goertz YMJ, Burtin C, Spruit MA, Braeken DCW, Dacha S, Franssen FME, Laveneziana P, Eber E, Troosters T, Neder JA, Puhan MA, Casaburi R, Vogiatzis I, Hebestreit H. ERS statement on standardisation of cardiopulmonary exercise testing in chronic lung diseases. Eur Respir Rev. 2019 Dec 18;28(154):180101. doi: 10.1183/16000617.0101-2018. Print 2019 Dec 31.
PubMed 31852745Watz H, Pitta F, Rochester CL, Garcia-Aymerich J, ZuWallack R, Troosters T, Vaes AW, Puhan MA, Jehn M, Polkey MI, Vogiatzis I, Clini EM, Toth M, Gimeno-Santos E, Waschki B, Esteban C, Hayot M, Casaburi R, Porszasz J, McAuley E, Singh SJ, Langer D, Wouters EF, Magnussen H, Spruit MA. An official European Respiratory Society statement on physical activity in COPD. Eur Respir J. 2014 Dec;44(6):1521-37. doi: 10.1183/09031936.00046814. Epub 2014 Oct 30.
PubMed 25359358Jamnick NA, Pettitt RW, Granata C, Pyne DB, Bishop DJ. An Examination and Critique of Current Methods to Determine Exercise Intensity. Sports Med. 2020 Oct;50(10):1729-1756. doi: 10.1007/s40279-020-01322-8.
PubMed 32729096Milani JGPO, Milani M, Cipriano GFB, Hansen D, Cipriano Junior G. Exercise intensity domains determined by heart rate at the ventilatory thresholds in patients with cardiovascular disease: new insights and comparisons to cardiovascular rehabilitation prescription recommendations. BMJ Open Sport Exerc Med. 2023 Jul 31;9(3):e001601. doi: 10.1136/bmjsem-2023-001601. eCollection 2023.
PubMed 37533593Hansen D, Junior GC, Milani JGPO, Milani M, Gojevic T, Machado FVC, Kambic T, Eijsvogels TMH, Bonifazi M, Dendale P, D'Ascenzi F. Advancing Aerobic Exercise Training Intensity Prescription in Health and Disease Beyond Standard Recommendations: A Call to Action. Sports Med. 2025 Sep;55(9):2111-2135. doi: 10.1007/s40279-025-02272-9. Epub 2025 Jul 4.
PubMed 40613962Mezzani A, Hamm LF, Jones AM, McBride PE, Moholdt T, Stone JA, Urhausen A, Williams MA; European Association for Cardiovascular Prevention and Rehabilitation; American Association of Cardiovascular and Pulmonary Rehabilitation; Canadian Association of Cardiac Rehabilitation. Aerobic exercise intensity assessment and prescription in cardiac rehabilitation: a joint position statement of the European Association for Cardiovascular Prevention and Rehabilitation, the American Association of Cardiovascular and Pulmonary Rehabilitation and the Canadian Association of Cardiac Rehabilitation. Eur J Prev Cardiol. 2013 Jun;20(3):442-67. doi: 10.1177/2047487312460484. Epub 2012 Oct 26.
PubMed 23104970Anselmi F, Cavigli L, Pagliaro A, Valente S, Valentini F, Cameli M, Focardi M, Mochi N, Dendale P, Hansen D, Bonifazi M, Halle M, D'Ascenzi F. The importance of ventilatory thresholds to define aerobic exercise intensity in cardiac patients and healthy subjects. Scand J Med Sci Sports. 2021 Sep;31(9):1796-1808. doi: 10.1111/sms.14007. Epub 2021 Jul 5.
PubMed 34170582Zainuldin R, Mackey MG, Alison JA. Prescription of walking exercise intensity from the 6-minute walk test in people with chronic obstructive pulmonary disease. J Cardiopulm Rehabil Prev. 2015 Jan-Feb;35(1):65-9. doi: 10.1097/HCR.0000000000000074.
PubMed 24983708Gloeckl R, Zwick RH, Furlinger U, Jarosch I, Schneeberger T, Leitl D, Koczulla AR, Vonbank K, Alexiou C, Vogiatzis I, Spruit MA. Prescribing and adjusting exercise training in chronic respiratory diseases - Expert-based practical recommendations. Pulmonology. 2023 Jul-Aug;29(4):306-314. doi: 10.1016/j.pulmoe.2022.09.004. Epub 2022 Oct 20.
PubMed 36272962Garber CE, Blissmer B, Deschenes MR, Franklin BA, Lamonte MJ, Lee IM, Nieman DC, Swain DP; American College of Sports Medicine. American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Med Sci Sports Exerc. 2011 Jul;43(7):1334-59. doi: 10.1249/MSS.0b013e318213fefb.
PubMed 21694556Esteban C, Arostegui I, Aburto M, Moraza J, Quintana JM, Aizpiri S, Basualdo LV, Capelastegui A. Influence of changes in physical activity on frequency of hospitalization in chronic obstructive pulmonary disease. Respirology. 2014 Apr;19(3):330-8. doi: 10.1111/resp.12239. Epub 2014 Feb 2.
PubMed 24483954
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FITME Study: Formulating Individualised Exercise Prescription in Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT07792642
- Acronym / sponsor ID
- FITME / 2025.04991.BDANA
- Keywords
- chronic obstructive pulmonary disease, ventilatory threshold, gas exchange threshold, physical activity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Aveiro UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 28 Aug 2026 (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.
This randomised controlled trial aims to: i) compare the power output at the first metabolic threshold (WMT1) between the MT1 and the six-minute walking test (6MWT)-based cardiorespiratory exercise prescriptions in chronic obstructive pulmonary disease (COPD); ii) compare exercise adherence, peripheral muscle strength, health-related quality of life, dyspnoea, fatigue, disease impact and emotional status between MT1 and 6MWT-based exercise prescriptions.
Patients will be recruited via the pulmonology services from Unidade Local de Saúde do Baixo Mondego and Unidade Local de Saúde de Aveiro.
Detailed description
Chronic obstructive pulmonary disease (COPD) is a progressive and impactful disease characterised by chronic ariflow. Beyond its primary respiratory symptoms (i.e. dyspnoea, sputum production, cough, and frequent exacerbations), COPD is often accompanied by systemic, extrapulmonary manifestations such as skeletal muscle dysfunction.
Exercise is a structured, purposeful subset of physical activity designed to improve or maintain one or more components of physical fitness and health benefits. Within the management of COPD, conventionally delivered through pulmonary rehabilitation programme, exercise training triggers crucial extrapulmonary adaptations. By improving peripheral muscle function and cardiovascular efficiency, it reduces the overall load on the pulmonary system, ultimately improving symptoms, preventing hospitalizations, and halting clinical deterioration. To achieve these adaptations, a minimum threshold of external load (typically moderate-intensity exercise) should be implemented. International guidelines and expert consensus recommend healthcare professionals to prescribe cardiorespiratory exercise based on field tests (i.e. 6MWT). However, as a submaximal assessment, the 6MWT typically elicits submaximal functional responses, which distinctively differ from the peak physiological demands captured during a cardiopulmonary exercise test (CPET). Recent evidence highlights the first metabolic threshold (MT1) as an optimal benchmark for prescribing cardiorespiratory exercise. This physiological marker establishes the transition from light to moderate exercise intensity and can be accurately determined via a CPET.
Sticking to traditional exercise prescription models can cause imprecise monitoring and dosing, which may compromise patient safety, increase frustration, and lower adherence. This ongoing uncertainty in prescribing cardiorespiratory exercise for people with COPD can impair pulmonary rehabilitation outcomes and potentially lead to flawed healthcare policy decisions.
Therefore, the primary aim of this study is to compare exercise prescription based on MT1 and on the 6MWT for improving power output at MT1 in people with COPD. Secondary aim is to compare exercise adherence, peripheral muscle strength, health-related quality of life, dyspnoea, fatigue, disease impact, and emotional status between MT1 and 6MWT-based prescriptions.
This study will be conducted at Unidade Local de Saúde do Baixo Mondego, Figueira da Foz, Unidade Local de Saúde da Região de Aveiro, and at the Laboratory of Research and Respiratory Rehabilitation of the School of Health Sciences of the University of Aveiro (LAB3R-ESSUA).
Patients with a formal diagnose of stable COPD and a maximal CPET with MT1 determination will be included. Individuals who have unstable or severe comorbidities (e.g., musculoskeletal, neurological, cardiovascular, neoplastic, or immunological) that prevent participation in pulmonary rehabilitation, as well as those who have completed or attended a pulmonary rehabilitation program within the past 12 months will be excluded.
Sociodemographic and general clinical data will be collected. Instruments assessing health-related quality of life, dyspnoea, fatigue, disease impact, emotional status, and cough will be applied.
Sample size calculation was performed using G*Power version 3.1 (Heinrich Heine University Düsseldorf, Germany).
A sample size calculation was computed using G*Power3.1.9.6 for the within-between interaction of a mixed ANOVA with two groups and 2 assessments (baseline and post pulmonary rehabilitation) of the primary outcome. The sample size was estimated considering an alpha=0.05, power=0.80, repeated measures correlation=0.5, nonsphericity correction=1, and a moderate effect, partial eta squared (η2) of 0.06, the required sample size was 34 participants. As the anticipated dropout rate was 25% a final anticipated sample size was 46 participants (23/group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metabolic Threshold-based exercise intensity prescription | Experimental | Other: Pulmonary rehabilitation programme |
| Six-minute walking test-based exercise intensity prescription | Active comparator | Other: Pulmonary rehabilitation programme |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of COPD;
- Complete a maximal CPET with MT1 identification.
Key exclusion criteria (2 listed)
- Presence of unstable or significant conditions (e.g. musculoskeletal, neurological, cardiovascular, neoplasia or immunological) that renders the participation in the pulmonary rehabilitation program infeasible;
- Participated in pulmonary rehabilitation in the last 12 months.
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 |
|---|---|---|
| Pulmonary rehabilitation programmeParticipants will undergo a supervised, in-person pulmonary rehabilitation programme lasting for twelve weeks, twice a week. The intervention comprises cardiorespiratory exercise training, conducted on either a treadmill or a cycle ergometer. Exercise intensity will be individually prescribed based on the power output registered at the first metabolic threshold, during a baseline cardiopulmonary exercise test. For treadmill exercise prescription, guideline-based estimation equations will be used to estimate treadmill velocity based on the oxygen uptake obtained in the first metabolic threshold. Resistance training will be provided in the same sessions as internationally recommended. Progress will occur on weekly basis, according to symptoms. Education and psychosocial support will also be provided once every other week. All sessions will range from 60-90 minutes. | Other | Metabolic Threshold-based exercise intensity prescription |
| Pulmonary rehabilitation programmeStandard of care (pulmonary rehabilitation programme featuring six-minute walking test-derived cardiorespiratory exercise prescription). | Other | Six-minute walking test-based exercise intensity prescription |
Primary outcome
Exercise capacity - Power output at first metabolic threshold
Time frame: From baseline (pre-intervention) to the end of the pulmonary rehabilitation programme (12 weeks)
Power output at first metabolic threshold will be measured during a cardiopulmonary exercise test (watts).
11 secondary outcomes
Exercise capacity - Peak power output
Time frame: From baseline (pre-intervention) to the end of the pulmonary rehabilitation programme (12 weeks)
Exercise capacity - Six-Minute Walk Test (6MWT)
Time frame: From baseline (pre-intervention) to the end of the pulmonary rehabilitation programme (12 weeks)
Cardiorespiratory fitness - Maximum oxygen uptake
Time frame: From baseline (pre-intervention) to the end of the pulmonary rehabilitation programme (12 weeks)
Handgrip strength
Time frame: From baseline (pre-intervention) to the end of the pulmonary rehabilitation programme (12 weeks)
Quadriceps Maximum Voluntary Strength (QMVS)
Time frame: From baseline (pre-intervention) to the end of the pulmonary rehabilitation programme (12 weeks)
One-Minute Sit-To-Stand (1min-STS)
Time frame: From baseline (pre-intervention) to the end of the pulmonary rehabilitation programme (12 weeks)
Disease impact - Chronic Airways Assessment Test (CAAT)
Time frame: From baseline (pre-intervention) to the end of the pulmonary rehabilitation programme (12 weeks)
Emotional Status - Hospital Anxiety and Depression Scale (HADS)
Time frame: From baseline (pre-intervention) to the end of the pulmonary rehabilitation programme (12 weeks)
Dyspnoea severity - Modified Medical Research Council Dyspnoea Questionnaire (mMRC)
Time frame: From baseline (pre-intervention) to the end of the pulmonary rehabilitation programme (12 weeks)
Health-Related Quality of Life - Saint-George's Respiratory Questionnaire (SGRQ)
Time frame: From baseline (pre-intervention) to the end of the pulmonary rehabilitation programme (12 weeks)
Fatigue severity - Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-FS)
Time frame: From baseline (pre-intervention) to the end of the pulmonary rehabilitation programme (12 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Background: PubMed 18760164Hill K, Jenkins SC, Cecins N, Philippe DL, Hillman DR, Eastwood PR. Estimating maximum work rate during incremental cycle ergometry testing from six-minute walk distance in patients with chronic obstructive pulmonary disease. Arch Phys Med Rehabil. 2008 Sep;89(9):1782-7. doi: 10.1016/j.apmr.2008.01.020.
- Background: PubMed 32229541Hansen H, Bieler T, Beyer N, Kallemose T, Wilcke JT, Ostergaard LM, Frost Andeassen H, Martinez G, Lavesen M, Frolich A, Godtfredsen NS. Supervised pulmonary tele-rehabilitation versus pulmonary rehabilitation in severe COPD: a randomised multicentre trial. Thorax. 2020 May;75(5):413-421. doi: 10.1136/thoraxjnl-2019-214246. Epub 2020 Mar 30.
- Background: PubMed 39173827Harvey-Dunstan TC, Baldwin MM, Tal-Singer R, Allinder M, Polkey MI, Hamilton A, Richardson M, Edwards SA, Steiner MC, Morgan MD, Singh SJ; COPD/MAP Consortium. The Responsiveness of Exercise Tests in COPD: A Randomized Controlled Trial. Chest. 2025 Jan;167(1):98-111. doi: 10.1016/j.chest.2024.05.051. Epub 2024 Aug 21.
- Background: PubMed 40074277Nie S, Wang L, Ma S, Sun H. Impact of silicone midline catheter tip location on catheter-related complications and indwelling duration: results from a multicentre randomised clinical trial in China. BMJ Open. 2025 Mar 12;15(3):e086717. doi: 10.1136/bmjopen-2024-086717.
- Background: PubMed 31852745Radtke T, Crook S, Kaltsakas G, Louvaris Z, Berton D, Urquhart DS, Kampouras A, Rabinovich RA, Verges S, Kontopidis D, Boyd J, Tonia T, Langer D, De Brandt J, Goertz YMJ, Burtin C, Spruit MA, Braeken DCW, Dacha S, Franssen FME, Laveneziana P, Eber E, Troosters T, Neder JA, Puhan MA, Casaburi R, Vogiatzis I, Hebestreit H. ERS statement on standardisation of cardiopulmonary exercise testing in chronic lung diseases. Eur Respir Rev. 2019 Dec 18;28(154):180101. doi: 10.1183/16000617.0101-2018. Print 2019 Dec 31.
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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.
Alda S Marques, PhD principal investigator
School of Health Sciences of the University of Aveiro (ESSUA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary rehabilitation programme in people with Chronic Obstructive Pulmonary Disease (COPD), run by Aveiro University 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 2 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: opening soon, as of the sponsor's last update on 1 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alda S Marques, PhD (00351 234 372 462, amarques@ua.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise capacity - Power output at first metabolic threshold (time frame: From baseline (pre-intervention) to the end of the pulmonary rehabilitation programme (12 weeks)). 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 NCT07792642, which also lists 21 linked publications.
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 1 Sep 2026.