Physical Activity Promotion Added to Standard Care Pulmonary Rehabilitation and Cognitive Behavioural Therapy

NCT03749655 | Completed

• 1 other identifier: 08968
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

In patients with Chronic Obstructive Pulmonary Disease (COPD) daily physical activity is reduced compared to healthy age-matched individuals. Reduced levels of physical activity in patients with COPD are associated with increased risk for exacerbations, hospital admissions and mortality. Pulmonary rehabilitation (PR) constitutes standard care for patients with COPD as it improves exercise capacity, quality of life and reduces the risk for exacerbation and hospitalisation. Participation in PR, however, does not necessarily translate into improved daily physical activity levels. It is currently uncertain whether addition of physical activity promotion strategies to standard PR programs induces an improvement in daily physical activity along with exercise capacity and quality of life compared to pulmonary rehabilitation alone. Physical activity (PA) is a complex health behaviour that is modified by behavioural change interventions. PA promotion programs through the use of wearable monitors (i.e. pedometers, accelerometers) with goal setting and feedback, have shown to increase daily physical activity, but not exercise capacity or quality of life in COPD patients. Therefore, combination of both PR and PA promotion strategies is necessary to translate PR-induced improvements in functional capacity into improved daily physical activity level. The investigators propose to perform a feasibility study assessing patient adherence to PA promotion incorporated into a standard PR program. To enhance adherence to the PA promotion strategy, Cognitive Behavioural Modification Strategies (CBM) will be provided to patients undertaking PR. CBM strategies facilitate the goals of PR as they address several behavioural barriers including anxiety, depression and physical inactivity, and constitutes an important component in the management of COPD to improve engagement with PR and promote a physically active lifestyle. The investigators will divide patients into two programs: one including PR, PA promotion and CBM and the other comprising standard PR and CBM provision. The investigators will compare patients' adherence (16 sessions of PR) to both programs.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Pulmonary Rehabilitation; Physical activity; Anxiety and depression

Outcome Measures

Primary Outcomes (2)

• Patient compliance with the physical activity promotion intervention

  Whether patients use the step counter for an 8 week period of physical activity promotion while undertaking pulmonary rehabilitation. Compliance to the intervention is defined as at least 4 days per week with valid step count data (\>70 steps/day). Over the 8-week program patients should have a minimum of 6 weeks (75%) compliance with the physical activity intervention.

  8 weeks (16 sessions)

• Patient Experience of Physical Activity

  Measured using the innovative Clinical Visit of COPD Questionnaire (C-PPAC)

  Measured 1 week prior and 1 week post rehabilitation

Secondary Outcomes (5)

• Change in daily physical activity.

  Measured 1 week prior and 1 week post rehabilitation

• Change in symptoms of anxiety and depression.

  Measured 1 week prior and 1 week post rehabilitation

• Change in functional capacity

  Measured 1 week prior and 1 week post rehabilitation

• Change in quality of life

  Measured 1 week prior and 1 week post rehabilitation

• Change in quality of life

  Measured 1 week prior and 1 week post rehabilitation

Study Arms (2)

PR+CBT

NO INTERVENTION

Standard care Pulmonary rehabilitation will be given alongside cognitive behavioural therapy

PR+CBT+PA Promotion.

EXPERIMENTAL

Standard care Pulmonary rehabilitation will be given alongside cognitive behavioural therapy and physical activity promotion.

Behavioral: Physical Activity Promotion

Interventions

Physical Activity Promotion BEHAVIORAL

The physical activity (PA) promotion intervention will be provided only to the intervention group, and will include: 1) a step-counter with a digital display, 2) an interview discussing motivational issues, favourite daily activities and strategies to become more physically active; and 3) a tailored physical activity coaching plan including an Individualised activity goal (in steps/day) revised twice weekly through consultation sessions (16 sessions in total). Patients' targets will be revised twice weekly during the consultation sessions which will be incorporated into the Pulmonary rehabilitation sessions. The aim is to increase physical activity by 10% each week. The goal can be altered if required.

PR+CBT+PA Promotion.

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COPD confirmed by obstructive spirometry
• Clinically stable male or female COPD patients aged 40 years or older
• Optimised medical therapy
• Able to provide informed consent
• HADS score of 8 and above

You may not qualify if:

• Orthopaedic, neurological or other concomitant diseases that significantly impair normal biomechanical movement patterns, as judged by the investigator.
• Moderate or severe COPD exacerbation (AECOPD) within 4 weeks.
• Unstable ischaemic heart disease, including myocardial infarction within 6 weeks.
• Moderate or severe aortic stenosis or hypertrophic obstructive cardiomyopathy.
• Uncontrolled hypertension.
• Another condition likely to limit life expectancy to less than one year (principally metastatic malignancy).

Sponsors & Collaborators

• Northumbria University: lead
• Newcastle-upon-Tyne Hospitals NHS Trust: collaborator

Study Sites (1)

Newcastle upon Tyne NHS trust

Newcastle upon Tyne, Tyne and Wear, NE18ST, United Kingdom

Location

Related Publications (9)

• 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, van der Molen T, Polkey M, Rabinovich RA, Vogiatzis I, Weisman I, Kulich K. Improving physical activity in COPD: towards a new paradigm. Respir Res. 2013 Oct 30;14(1):115. doi: 10.1186/1465-9921-14-115.

  PMID: 24229341 BACKGROUND

• 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

• 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

• Lahham A, McDonald CF, Holland AE. Exercise training alone or with the addition of activity counseling improves physical activity levels in COPD: a systematic review and meta-analysis of randomized controlled trials. Int J Chron Obstruct Pulmon Dis. 2016 Dec 8;11:3121-3136. doi: 10.2147/COPD.S121263. eCollection 2016.

  PMID: 27994451 BACKGROUND

• Ng TP, Niti M, Tan WC, Cao Z, Ong KC, Eng P. Depressive symptoms and chronic obstructive pulmonary disease: effect on mortality, hospital readmission, symptom burden, functional status, and quality of life. Arch Intern Med. 2007 Jan 8;167(1):60-7. doi: 10.1001/archinte.167.1.60.

  PMID: 17210879 BACKGROUND

• Heslop K, Foley T. Using cognitive behavioural therapy to address the psychological needs of patients with COPD. Nurs Times. 2009 Sep 29-Oct 5;105(38):18-9.

  PMID: 19860064 BACKGROUND

• Armstrong M, Hume E, McNeillie L, Chambers F, Wakenshaw L, Burns G, Marshall KH, Vogiatzis I. Behavioural modification interventions alongside pulmonary rehabilitation improve COPD patients' experiences of physical activity. Respir Med. 2021 Apr-May;180:106353. doi: 10.1016/j.rmed.2021.106353. Epub 2021 Mar 9.

  PMID: 33735798 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Principle investigator will be blinded from the randomisation as this member will conduct CBT with all patients.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single centre feasibility, single blind, parallel, randomised controlled study.

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: November 21, 2018
• Study Start: November 20, 2018
• Primary Completion: April 1, 2021
• Study Completion: August 31, 2021
• Last Updated: April 5, 2022

Record last verified: 2022-04

Locations

GB (1)