FITME Study: Formulating Individualised Exercise Prescription in Chronic Obstructive Pulmonary Disease

NCT07792642 | Not Yet Recruiting

• 2 other identifiers: 2025.04991.BDANA2025
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

chronic obstructive pulmonary disease; ventilatory threshold; gas exchange threshold; physical activity

Outcome Measures

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).

  From baseline (pre-intervention) to the end of the pulmonary rehabilitation programme (12 weeks)

Secondary Outcomes (11)

• Exercise capacity - Peak power output

  From baseline (pre-intervention) to the end of the pulmonary rehabilitation programme (12 weeks)

• Exercise capacity - Six-Minute Walk Test (6MWT)

  From baseline (pre-intervention) to the end of the pulmonary rehabilitation programme (12 weeks)

• Cardiorespiratory fitness - Maximum oxygen uptake

  From baseline (pre-intervention) to the end of the pulmonary rehabilitation programme (12 weeks)

• Handgrip strength

  From baseline (pre-intervention) to the end of the pulmonary rehabilitation programme (12 weeks)

• Quadriceps Maximum Voluntary Strength (QMVS)

  From baseline (pre-intervention) to the end of the pulmonary rehabilitation programme (12 weeks)

Study Arms (2)

Metabolic Threshold-based exercise intensity prescription

EXPERIMENTAL

Other: Non-pharmacological intervention: Pulmonary rehabilitation programme

Six-minute walking test-based exercise intensity prescription

ACTIVE COMPARATOR

Other: Non-pharmacological intervention: Pulmonary rehabilitation programme

Interventions

Non-pharmacological intervention: Pulmonary rehabilitation programme OTHER

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.

Metabolic Threshold-based exercise intensity prescription

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of COPD;
• Complete a maximal CPET with MT1 identification.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aveiro University: lead

Study Sites (1)

University of Aveiro

Aveiro, Portugal

Location

Related Publications (21)

• 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.

  PMID: 18760164 BACKGROUND

• Hansen 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.

  PMID: 32229541 BACKGROUND

• Harvey-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.

  PMID: 39173827 BACKGROUND

• Nie 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.

  PMID: 40074277 BACKGROUND

• Radtke 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.

  PMID: 31852745 BACKGROUND

• Watz 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.

  PMID: 25359358 BACKGROUND

• Jamnick 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.

  PMID: 32729096 BACKGROUND

• Milani 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.

  PMID: 37533593 BACKGROUND

• Hansen 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.

  PMID: 40613962 BACKGROUND

• Mezzani 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.

  PMID: 23104970 BACKGROUND

• Anselmi 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.

  PMID: 34170582 BACKGROUND

• Zainuldin 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.

  PMID: 24983708 BACKGROUND

• Gloeckl 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.

  PMID: 36272962 BACKGROUND

• Garber 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.

  PMID: 21694556 BACKGROUND

• Esteban 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.

  PMID: 24483954 BACKGROUND

• Machado FVC, Coninx K, Neunhaeuserer D, Tonoli C, Niebauer J, Piepoli M, Pedretti R, Kouidi E, Ambrosetti M, Dendale P, Bjarnason-Wehrens B, Beckers P, Cornelissen V, Barna O, Doherty P, Rauch B, Edelmann F, Schwaab B, Takken T, Reibis R, Davos CH, Garcia-Porrero E, Pitta F, Hernandes NA, Stickland MK, Gimeno-Santos E, De Brandt J, Nyberg A, Machado A, Marques A, Burtin C, Gloeckl R, Vogiatzis I, Balbi B, Jensen D, Man WD, Rochester CL, Singh SJ, Franssen FME, Spruit MA, Hansen D. Tailored Exercise Prescription for People with COPD and Clinically Relevant Comorbidities: A Consensus Statement of the EXPERT Working Group and Experts in Pulmonary Rehabilitation. Sports Med. 2026 Jan;56(1):97-116. doi: 10.1007/s40279-025-02353-9. Epub 2025 Dec 4.

  PMID: 41343041 BACKGROUND

• McCarthy B, Casey D, Devane D, Murphy K, Murphy E, Lacasse Y. Pulmonary rehabilitation for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2015 Feb 23;2015(2):CD003793. doi: 10.1002/14651858.CD003793.pub3.

  PMID: 25705944 BACKGROUND

• Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, Hill K, Holland AE, Lareau SC, Man WD, Pitta F, Sewell L, Raskin J, Bourbeau J, Crouch R, Franssen FM, Casaburi R, Vercoulen JH, Vogiatzis I, Gosselink R, Clini EM, Effing TW, Maltais F, van der Palen J, Troosters T, Janssen DJ, Collins E, Garcia-Aymerich J, Brooks D, Fahy BF, Puhan MA, Hoogendoorn M, Garrod R, Schols AM, Carlin B, Benzo R, Meek P, Morgan M, Rutten-van Molken MP, Ries AL, Make B, Goldstein RS, Dowson CA, Brozek JL, Donner CF, Wouters EF; ATS/ERS Task Force on Pulmonary Rehabilitation. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med. 2013 Oct 15;188(8):e13-64. doi: 10.1164/rccm.201309-1634ST.

  PMID: 24127811 BACKGROUND

• Bishop DJ, Beck B, Biddle SJH, Denay KL, Ferri A, Gibala MJ, Headley S, Jones AM, Jung M, Lee MJ, Moholdt T, Newton RU, Nimphius S, Pescatello LS, Saner NJ, Tzarimas C. Physical Activity and Exercise Intensity Terminology: A Joint American College of Sports Medicine (ACSM) Expert Statement and Exercise and Sport Science Australia (ESSA) Consensus Statement. Med Sci Sports Exerc. 2025 Nov 1;57(11):2599-2613. doi: 10.1249/MSS.0000000000003795.

  PMID: 41085254 BACKGROUND

• Maltais F, Decramer M, Casaburi R, Barreiro E, Burelle Y, Debigare R, Dekhuijzen PN, Franssen F, Gayan-Ramirez G, Gea J, Gosker HR, Gosselink R, Hayot M, Hussain SN, Janssens W, Polkey MI, Roca J, Saey D, Schols AM, Spruit MA, Steiner M, Taivassalo T, Troosters T, Vogiatzis I, Wagner PD; ATS/ERS Ad Hoc Committee on Limb Muscle Dysfunction in COPD. An official American Thoracic Society/European Respiratory Society statement: update on limb muscle dysfunction in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2014 May 1;189(9):e15-62. doi: 10.1164/rccm.201402-0373ST.

  PMID: 24787074 BACKGROUND

• Wang Z, Lin J, Liang L, Huang F, Yao X, Peng K, Gao Y, Zheng J. Global, regional, and national burden of chronic obstructive pulmonary disease and its attributable risk factors from 1990 to 2021: an analysis for the Global Burden of Disease Study 2021. Respir Res. 2025 Jan 2;26(1):2. doi: 10.1186/s12931-024-03051-2.

  PMID: 39748260 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Alda S Marques, PhD

  School of Health Sciences of the University of Aveiro (ESSUA)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alda S Marques, PhD

CONTACT

00351 234 372 462; amarques@ua.pt

Odete M Alves, MSc

CONTACT

00351 234 372 476; odete.alves@ua.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): July 31, 2029
• Last Updated: August 28, 2026

Record last verified: 2026-08

Locations

PT (1)