Physical Activity Enhancing Programme in COPD

NCT02347566 | Completed DMC

• 1 other identifier: 2014/0380
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with Chronic Obstructive Pulmonary Disease are characterised by a sedentary lifestyle. This contributes to increase the number of hospitalizations and mortality. Changing this lifestyle is a major objective of the management of these patients. Pulmonary rehabilitation helps patients to increase their fitness, but modifying a longstanding sedentary habit is more difficult to achieve. This project aims at modifying patients' long term physical activity with a physical activity coaching programme. This will help patients to transform the benefits of pulmonary rehabilitation into a healthier active lifestyle and contribute to reduce hospitalizations, increase quality of life and survival.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; Physical Activity; Accelerometer

Outcome Measures

Primary Outcomes (2)

• Change from Baseline in Physical Activity in Daily Life (PADL) levels at 12 weeks.

  The assessment of physical activity in daily life will be conducted with a validated activity monitor to assess physical activity levels (PAL) in patients with COPD, the triaxial Actigraph GT3x accelerometer. This is a small (4.6cm x 3.3cm x 1.5cm), lightweight (19 grams) and portable device that is worn around the hip to assess movement and provide several outputs reflecting PADL (i.e. raw acceleration, energy expenditure, MET rates, steps taken, physical activity intensity, subject position) by its triaxial sensor, tracking the body motion every time subjects move up, down, forwards, backwards and sideways. By measuring the acceleration of these movements, it calculates how much energy subjects used to make them. The device will be used by the patients for at least 10 hours/day during the evaluation period of one week simultaneously with the baseline assessment of PAL conducted by the DirectLife.

  12 weeks

• Change from Baseline in Physical Activity in Daily Life (PADL) levels at 24 weeks.

  The assessment of physical activity in daily life will be conducted with a validated activity monitor to assess physical activity levels (PAL) in patients with COPD, the triaxial Actigraph GT3x accelerometer. This is a small (4.6cm x 3.3cm x 1.5cm), lightweight (19 grams) and portable device that is worn around the hip to assess movement and provide several outputs reflecting PADL (i.e. raw acceleration, energy expenditure, MET rates, steps taken, physical activity intensity, subject position) by its triaxial sensor, tracking the body motion every time subjects move up, down, forwards, backwards and sideways. By measuring the acceleration of these movements, it calculates how much energy subjects used to make them. The device will be used by the patients for at least 10 hours/day during the evaluation period of one week simultaneously with the baseline assessment of PAL conducted by the DirectLife.

  24 weeks

Secondary Outcomes (15)

• Change from Baseline in Exercise Capacity at 12 weeks.

  12 weeks

• Change from Baseline in Exercise Capacity at 24 weeks.

  24 weeks

• Change from Baseline in Peripheral Muscle Strength at 12 weeks.

  12 weeks

• Change from Baseline in Peripheral Muscle Strength at 24 weeks.

  24 weeks

• Change from Baseline in Health Related Quality of Life (HRQoL) at 12 weeks.

  12 weeks

Study Arms (2)

Physical activity enhancing programme

EXPERIMENTAL

Usual care + physical activity enhancing programme (PAEP) (Study group, \[S\]), which includes both pulmonary rehabilitation programme plus the PAEP using an activity monitor (DirectLife) with set targets of physical activity levels to stimulate and increase physical activity in daily life.

Behavioral: Physical activity enhancing programme

Control

OTHER

Usual care (control, \[C\]) that includes only the pulmonary rehabilitation programme with the use of an activity monitor (DirectLife) in daily routine without any feedback or incentive to increase physical activity in daily life.

Other: Usual care

Interventions

Physical activity enhancing programme BEHAVIORAL

COPD patients performing pulmonary rehabilitation will wear the DirectLife activity monitor with set targets and feedback. They will have access to a web coaching programme. Their physical activity targets will be updated on a weekly basis in order to enhance their physical activity.

Physical activity enhancing programme

Usual care OTHER

COPD patients performing pulmonary rehabilitation will wear the DirectLife activity monitor without set targets and/or feedback. They will not have access to a web coaching programme.

Control

Eligibility Criteria

• Age: 30 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD, 2013) referred for pulmonary rehabilitation;
• Clinical stability concerning pulmonary infections or acute exacerbations within last four weeks;
• Absence of recent Myocardial Infarction (within last 3 months), unstable angina, other significant cardiac problems, SBP \> 180 mmHg, DBP \> 100 mmHg or tachycardia (higher than 100 bpm);
• Absence of significant orthopaedic, neurological, cognitive and/or psychiatric impairment restricting mobility;
• Not following any exercise programme in the last 6 months.

You may not qualify if:

• Orthopaedic, neurological or other complaints that significantly impair normal biomechanical movement patterns, as judged by the investigator;
• Respiratory diseases other than COPD (e.g. asthma);
• COPD exacerbations within 4 weeks prior to Visit 1;
• Cognitive impairment and inability to give informed consent, as judged by the investigator;
• Involvement in the planning and/or conduct of the study;
• Participants should not be taking part in any other studies.

Sponsors & Collaborators

• University of Edinburgh: lead
• Philips Healthcare: collaborator

Study Sites (1)

Physiotherapy Department - Leith Community Treatment Centre

Edinburgh, EH6 5JA, United Kingdom

Location

Related Publications (8)

• Pitta F, Troosters T, Spruit MA, Probst VS, Decramer M, Gosselink R. Characteristics of physical activities in daily life in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2005 May 1;171(9):972-7. doi: 10.1164/rccm.200407-855OC. Epub 2005 Jan 21.

  PMID: 15665324 BACKGROUND

• Garcia-Aymerich J, Lange P, Benet M, Schnohr P, Anto JM. Regular physical activity reduces hospital admission and mortality in chronic obstructive pulmonary disease: a population based cohort study. Thorax. 2006 Sep;61(9):772-8. doi: 10.1136/thx.2006.060145. Epub 2006 May 31.

  PMID: 16738033 BACKGROUND

• 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: 16760357 BACKGROUND

• Pitta F, Troosters T, Probst VS, Langer D, Decramer M, Gosselink R. Are patients with COPD more active after pulmonary rehabilitation? Chest. 2008 Aug;134(2):273-280. doi: 10.1378/chest.07-2655. Epub 2008 Apr 10.

  PMID: 18403667 BACKGROUND

• Breyer MK, Breyer-Kohansal R, Funk GC, Dornhofer N, Spruit MA, Wouters EF, Burghuber OC, Hartl S. Nordic walking improves daily physical activities in COPD: a randomised controlled trial. Respir Res. 2010 Aug 22;11(1):112. doi: 10.1186/1465-9921-11-112.

  PMID: 20727209 BACKGROUND

• de Blok BM, de Greef MH, ten Hacken NH, Sprenger SR, Postema K, Wempe JB. The effects of a lifestyle physical activity counseling program with feedback of a pedometer during pulmonary rehabilitation in patients with COPD: a pilot study. Patient Educ Couns. 2006 Apr;61(1):48-55. doi: 10.1016/j.pec.2005.02.005. Epub 2006 Feb 7.

  PMID: 16455222 BACKGROUND

• Rabinovich RA, Louvaris Z, Raste Y, Langer D, Van Remoortel H, Giavedoni S, Burtin C, Regueiro EM, Vogiatzis I, Hopkinson NS, Polkey MI, Wilson FJ, Macnee W, Westerterp KR, Troosters T; PROactive Consortium. Validity of physical activity monitors during daily life in patients with COPD. Eur Respir J. 2013 Nov;42(5):1205-15. doi: 10.1183/09031936.00134312. Epub 2013 Feb 8.

  PMID: 23397303 BACKGROUND

• Vestbo J, Hurd SS, Agusti AG, Jones PW, Vogelmeier C, Anzueto A, Barnes PJ, Fabbri LM, Martinez FJ, Nishimura M, Stockley RA, Sin DD, Rodriguez-Roisin R. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2013 Feb 15;187(4):347-65. doi: 10.1164/rccm.201204-0596PP. Epub 2012 Aug 9.

  PMID: 22878278 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

• Roberto Rabinovich, Post PhD

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2015
• First Posted: January 27, 2015
• Study Start: February 1, 2015
• Primary Completion: March 30, 2017
• Study Completion: March 30, 2017
• Last Updated: April 19, 2017

Record last verified: 2017-04

Locations

GB (1)