FITME Study: Formulating Individualised Exercise Prescription in Chronic Obstructive Pulmonary Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAveiro University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinical diagnosis of COPD;
Complete a maximal CPET with MT1 identification.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Pulmonary rehabilitation programme
Other interventionParticipants 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 programme
Other interventionStandard of care (pulmonary rehabilitation programme featuring six-minute walking test-derived cardiorespiratory exercise prescription).
Treatment groups
46 Participants
are divided into 2 treatment groupsGroup A: Metabolic Threshold-based exercise intensity prescriptionExperimental treatment 1 intervention
Group B: Six-minute walking test-based exercise intensity prescriptionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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)2
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)3
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)4
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)Sponsors and contacts
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Source ClinicalTrials.gov
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