Personalised Exercise Training in COPD

NCT03817294 | Completed

• 1 other identifier: IRAS 243125
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Exercise training as part of Pulmonary Rehabilitation (PR) has been shown conclusively to improve breathlessness,quality of life and exercise capacity for people with COPD. However generally PR is delivered in a 'one size fits all' approach without considering different aspects of an individual's disease. It is hypothesised that a more personalised approach to PR may yield even better results. However to design a personalised programme of PR we need a better understanding of how different people with COPD respond to different possible exercise training modalities. This study will therefore comprehensively characterise a group of patients and then ask them to complete 3 weeks of exercise training in one of four modalities; conventional cycling, eccentric cycling, one-legged cycling and resistance training. The aim is not to prove which type of training is more effective but to develop an idea of which groups of patients would benefit from which type of training. Baseline measures would be designed to fully understand how an individual responds to exercise and would therefore be comprised of a variety of endurance tests, strength tests, questionnaires, and measurements of lung capacity and body composition. This is to give as much information as possible to identify different responses to exercise.

Conditions

COPD

Outcome Measures

Primary Outcomes (3)

• Training Progression (Total work during training relative to baseline)

  (Total load during training in kJ or kg depending on exercise modality)/(load performed at baseline). This will therefore be presented as a standardised proportion (%) with no unit of measurement. Load refers to the total force production during exercise. For 2 leg and 1 leg concentric cycling and eccentric cycling this refers power output of the ergometer - total energy produced. For resistance exercise this refers to total weight lifted during training (in kg), i.e. weight lifted multiplied by number of repetitions.

  3 weeks

• Training adherence

  (percentage of training sessions attended)

  3 weeks

• Subjective exercise experience scale during each exercise modality

  Validated 12 point questionnaire with each question scoring from 1 (not at all) to 7(very much so). 3 domains - fatigue (high score=high fatigue), positive well-being (high score=high positive well being) and psychological distress (high score=high distress). Each domain represents 4 questions and the score for each domain (from 4-28) will be presented. Completed during all 4 exercise modalities (eccentric cycling, resistance training, single leg cycling and concentric cycling) for each participant

  Week 2

Secondary Outcomes (18)

• Experience of different exercise modalities - Qualitative questionnaire

  3 weeks

• Exercise capacity - peak V̇O2 during a maximal incremental 2 leg cycle test

  Baseline

• Exercise capacity - peak V̇O2 during a maximal incremental 1 leg cycle test

  Baseline

• Inspiratory capacity during maximal 2 leg cycling

  Baseline

• Functional capacity - constant work rate cycling test

  Baseline

Study Arms (4)

Eccentric cycling

ACTIVE COMPARATOR

Other: Comparison of exercise training modalities

Concentric cycling

ACTIVE COMPARATOR

Other: Comparison of exercise training modalities

Single leg cycling

ACTIVE COMPARATOR

Other: Comparison of exercise training modalities

Lower limb resistance training

ACTIVE COMPARATOR

Other: Comparison of exercise training modalities

Interventions

Comparison of exercise training modalities OTHER

As above

Concentric cycling; Eccentric cycling; Lower limb resistance training; Single leg cycling

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female, aged 40 years or above
• Diagnosis of COPD
• FEV1/FVC \<0.7 and FEV1 \< 80% predicted
• Medical Research Council (MRC) dyspnoea scale ≥3
• Participant is willing and able to give informed consent for participation in the study.
• Stable dose of current regular medication for at least 4 weeks prior to study entry.
• Participant has clinically acceptable ECG at enrolment.
• Able (in the Investigators opinion) and willing to comply with all study requirements.
• English speaking

You may not qualify if:

• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
• Any major or uncontrolled comorbidity that would impair the participant's ability to exercise or would mean exercise was unsafe.
• Participants who have participated in another research study involving an investigational product in the past 12 weeks
• Participation in pulmonary rehabilitation in the preceding 6 months
• Participation in another research study involving exercise training in the preceding 6 months
• Acute exacerbation in the preceding 4 weeks (would become eligible 4 weeks following recovery)
• Scheduled elective surgery or other procedures requiring general anaesthesia during the study.

Sponsors & Collaborators

• Loughborough University: lead

Study Sites (1)

Loughborough University

Loughborough, LE11 3TU, United Kingdom

Location

Related Publications (6)

• 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

• Troosters T, Gosselink R, Decramer M. Exercise training in COPD: how to distinguish responders from nonresponders. J Cardiopulm Rehabil. 2001 Jan-Feb;21(1):10-7. doi: 10.1097/00008483-200101000-00004.

  PMID: 11271652 BACKGROUND

• Camillo CA, Osadnik CR, van Remoortel H, Burtin C, Janssens W, Troosters T. Effect of "add-on" interventions on exercise training in individuals with COPD: a systematic review. ERJ Open Res. 2016 Mar 29;2(1):00078-2015. doi: 10.1183/23120541.00078-2015. eCollection 2016 Jan.

  PMID: 27730178 BACKGROUND

• Rocha Vieira DS, Baril J, Richard R, Perrault H, Bourbeau J, Taivassalo T. Eccentric cycle exercise in severe COPD: feasibility of application. COPD. 2011 Aug;8(4):270-4. doi: 10.3109/15412555.2011.579926. Epub 2011 Jul 5.

  PMID: 21728805 BACKGROUND

• Bjorgen S, Helgerud J, Husby V, Steinshamn S, Richadson RR, Hoff J. Aerobic high intensity one-legged interval cycling improves peak oxygen uptake in chronic obstructive pulmonary disease patients; no additional effect from hyperoxia. Int J Sports Med. 2009 Dec;30(12):872-8. doi: 10.1055/s-0029-1238292.

  PMID: 19821224 BACKGROUND

• Evans RA, Dolmage TE, Mangovski-Alzamora S, Romano J, O'Brien L, Brooks D, Goldstein RS. One-Legged Cycle Training for Chronic Obstructive Pulmonary Disease. A Pragmatic Study of Implementation to Pulmonary Rehabilitation. Ann Am Thorac Soc. 2015 Oct;12(10):1490-7. doi: 10.1513/AnnalsATS.201504-231OC.

  PMID: 26291542 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical PhD student

Model Details: This a pilot/feasibility study, aiming to characterise exercise limitation at baseline and then conducting an abridged RCT with 4 training arms. The main outcomes are related to training progression and perception

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: January 25, 2019
• Study Start: October 3, 2018
• Primary Completion: August 2, 2019
• Study Completion: August 2, 2019
• Last Updated: September 9, 2020

Record last verified: 2020-09

Locations

GB (1)