NCT02930421

Brief Summary

The primary aim of this clinical study is to investigate if exercise training can improve exercise capacity and quality of life in dyspneic mild chronic obstructive pulmonary disease patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 12, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

October 11, 2019

Status Verified

October 1, 2019

Enrollment Period

3.3 years

First QC Date

October 10, 2016

Last Update Submit

October 9, 2019

Conditions

COPD

Keywords

mild COPDExercise trainingSix minute walking distanceQuality of lifeSaint George Respiratory Questionnaire (SGRQ)

Outcome Measures

Primary Outcomes (1)

  • Change in the six minute walking distance

    Baseline and 8 weeks

Secondary Outcomes (2)

  • Change in disease specific quality of life (SGRQ)

    Baseline and 8 weeks

  • Change in exercise time during constant-load cycle exercise

    Baseline and 8 weeks

Study Arms (2)

Exercise training (ET)

EXPERIMENTAL

Patients will enter an 8-week ET program of 3 days per week supervised exercise training at the Rehabilitation Physiotherapy Gymnasium. Exercise training will include high-intensity endurance training at 60-80% of baseline peak work rate and strength training of upper and lower limbs with 3 sets of 6 repetitions at 50% of one repetition maximum. Each session will be 60 min duration, 30 min dedicated to cycle exercise.

Other: Exercise training

Usual care (UC)

NO INTERVENTION

The UC group will receive usual outpatient care and follow-up.

Interventions

Exercise trainingOTHER

30 min of exercise on a cycle ergometer at 80% of HRmax, 30 min of strength training of upper and lower limbs

Exercise training (ET)

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male or female subjects, aged 45-80 years
  • baseline post-bronchodilator forced expiratory volume at one second (FEV1) ≥80% of predicted normal and baseline (post-bronchodilator) FEV1/forced vital capacity (FVC) ≤70%
  • current or ex-smokers with a smoking history of at least 10 pack-years
  • dyspnea during activities of daily life, defined as modified Medical Research Council (mMRC) scale \[0-4 points\] ≥1 point

You may not qualify if:

  • history of asthma or other chronic lung disease (e.g.: interstitial lung disease; sarcoidosis; tuberculosis; cystic fibrosis; bronchiectasis; previous lung resection)
  • comorbidities that would prevent the patient from performing an exercise test (including psychological or cognitive disorders): chronic congestive heart failure; recent myocardial infarction \[6 months or less\]; cardiac arrhythmia requiring drug therapy; neuromuscular and peripheral vascular diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Respiratory Department; Hospital Clinico Universidad Catolica

Santiago, Chile

Location

Related Publications (13)

  • Shrikrishna D, Patel M, Tanner RJ, Seymour JM, Connolly BA, Puthucheary ZA, Walsh SL, Bloch SA, Sidhu PS, Hart N, Kemp PR, Moxham J, Polkey MI, Hopkinson NS. Quadriceps wasting and physical inactivity in patients with COPD. Eur Respir J. 2012 Nov;40(5):1115-22. doi: 10.1183/09031936.00170111. Epub 2012 Feb 23.

    PMID: 22362854BACKGROUND

  • Diaz AA, Morales A, Diaz JC, Ramos C, Klaassen J, Saldias F, Aravena C, Diaz R, Lisboa C, Washko GR, Diaz O. CT and physiologic determinants of dyspnea and exercise capacity during the six-minute walk test in mild COPD. Respir Med. 2013 Apr;107(4):570-9. doi: 10.1016/j.rmed.2012.12.011. Epub 2013 Jan 9.

    PMID: 23313036BACKGROUND

  • Bernard S, LeBlanc P, Whittom F, Carrier G, Jobin J, Belleau R, Maltais F. Peripheral muscle weakness in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1998 Aug;158(2):629-34. doi: 10.1164/ajrccm.158.2.9711023.

    PMID: 9700144BACKGROUND

  • Seymour JM, Ward K, Sidhu PS, Puthucheary Z, Steier J, Jolley CJ, Rafferty G, Polkey MI, Moxham J. Ultrasound measurement of rectus femoris cross-sectional area and the relationship with quadriceps strength in COPD. Thorax. 2009 May;64(5):418-23. doi: 10.1136/thx.2008.103986. Epub 2009 Jan 21.

    PMID: 19158125BACKGROUND

  • Seymour JM, Spruit MA, Hopkinson NS, Natanek SA, Man WD, Jackson A, Gosker HR, Schols AM, Moxham J, Polkey MI, Wouters EF. The prevalence of quadriceps weakness in COPD and the relationship with disease severity. Eur Respir J. 2010 Jul;36(1):81-8. doi: 10.1183/09031936.00104909. Epub 2009 Nov 6.

    PMID: 19897554BACKGROUND

  • Baarends EM, Schols AM, Mostert R, Wouters EF. Peak exercise response in relation to tissue depletion in patients with chronic obstructive pulmonary disease. Eur Respir J. 1997 Dec;10(12):2807-13. doi: 10.1183/09031936.97.10122807.

    PMID: 9493665BACKGROUND

  • Casaburi R. Limitation to exercise tolerance in chronic obstructive pulmonary disease: look to the muscles of ambulation. Am J Respir Crit Care Med. 2003 Aug 15;168(4):409-10. doi: 10.1164/rccm.2305013. No abstract available.

    PMID: 12912729BACKGROUND

  • Singer J, Yelin EH, Katz PP, Sanchez G, Iribarren C, Eisner MD, Blanc PD. Respiratory and skeletal muscle strength in chronic obstructive pulmonary disease: impact on exercise capacity and lower extremity function. J Cardiopulm Rehabil Prev. 2011 Mar-Apr;31(2):111-9. doi: 10.1097/HCR.0b013e3182033663.

    PMID: 21240003BACKGROUND

  • 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: 24127811BACKGROUND

  • Jacome C, Marques A. Pulmonary rehabilitation for mild COPD: a systematic review. Respir Care. 2014 Apr;59(4):588-94. doi: 10.4187/respcare.02742. Epub 2013 Oct 8.

    PMID: 24106321BACKGROUND

  • Rochester CL, Vogiatzis I, Holland AE, Lareau SC, Marciniuk DD, Puhan MA, Spruit MA, Masefield S, Casaburi R, Clini EM, Crouch R, Garcia-Aymerich J, Garvey C, Goldstein RS, Hill K, Morgan M, Nici L, Pitta F, Ries AL, Singh SJ, Troosters T, Wijkstra PJ, Yawn BP, ZuWallack RL; ATS/ERS Task Force on Policy in Pulmonary Rehabilitation. An Official American Thoracic Society/European Respiratory Society Policy Statement: Enhancing Implementation, Use, and Delivery of Pulmonary Rehabilitation. Am J Respir Crit Care Med. 2015 Dec 1;192(11):1373-86. doi: 10.1164/rccm.201510-1966ST.

    PMID: 26623686BACKGROUND

  • Nici L, Donner C, Wouters E, Zuwallack R, Ambrosino N, Bourbeau J, Carone M, Celli B, Engelen M, Fahy B, Garvey C, Goldstein R, Gosselink R, Lareau S, MacIntyre N, Maltais F, Morgan M, O'Donnell D, Prefault C, Reardon J, Rochester C, Schols A, Singh S, Troosters T; ATS/ERS Pulmonary Rehabilitation Writing Committee. American Thoracic Society/European Respiratory Society statement on pulmonary rehabilitation. Am J Respir Crit Care Med. 2006 Jun 15;173(12):1390-413. doi: 10.1164/rccm.200508-1211ST. No abstract available.

    PMID: 16760357BACKGROUND

  • Langer D, Hendriks E, Burtin C, Probst V, van der Schans C, Paterson W, Verhoef-de Wijk M, Straver R, Klaassen M, Troosters T, Decramer M, Ninane V, Delguste P, Muris J, Gosselink R. A clinical practice guideline for physiotherapists treating patients with chronic obstructive pulmonary disease based on a systematic review of available evidence. Clin Rehabil. 2009 May;23(5):445-62. doi: 10.1177/0269215509103507. Epub 2009 Apr 23.

    PMID: 19389745BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Exercise

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Orlando Díaz

    Departamento de Enfermedades Respiratorias

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2016

First Posted

October 12, 2016

Study Start

March 1, 2015

Primary Completion

June 30, 2018

Study Completion

September 30, 2018

Last Updated

October 11, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will share

Locations

CL(1)