An interventional study of Pulmonary rehabilitation programme and Pulmonary rehabilitation programme in Chronic Obstructive Pulmonary Disease (COPD), sponsored by Aveiro University. Not yet recruiting at 1 site in Portugal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Aveiro University · Not applicable, Interventional, and Treatment
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.
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).
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's planned enrollment of 46 is below the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Aveiro University is the lead sponsor of 59 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Pulmonary rehabilitation programme
Other: Pulmonary rehabilitation programme
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.
Standard of care (pulmonary rehabilitation programme featuring six-minute walking test-derived cardiorespiratory exercise prescription).
Exercise capacity - Power output at first metabolic threshold
Power output at first metabolic threshold will be measured during a cardiopulmonary exercise test (watts).
Time frame: From baseline (pre-intervention) to the end of the pulmonary rehabilitation programme (12 weeks)
Exercise capacity - Peak power output
Peak power output will be measured during a cardiopulmonary exercise test (watts).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
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)
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").
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)
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).
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)
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.
Time frame: From baseline (pre-intervention) to the end of the pulmonary rehabilitation programme (12 weeks)
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pulmonary Disease, Chronic Obstructive →
Aveiro University