Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 3 for:    15665324 [PUBMED-IDS]

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03749655
Recruitment Status : Recruiting
First Posted : November 21, 2018
Last Update Posted : November 21, 2018
Sponsor:
Collaborator:
Newcastle-upon-Tyne Hospitals NHS Trust
Information provided by (Responsible Party):
Northumbria University

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.


Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Behavioral: Physical Activity Promotion Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single centre feasibility, single blind, parallel, randomised controlled study.
Masking: None (Open Label)
Masking Description: Principle investigator will be blinded from the randomisation as this member will conduct CBT with all patients.
Primary Purpose: Other
Official Title: A Feasibility Study Assessing the Inclusion of Physical Activity Promotion to Standard Care Pulmonary Rehabilitation and Cognitive Behavioural Therapy in Patients With COPD Who Are Anxious and Depressed
Actual Study Start Date : November 20, 2018
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: PR+CBT
Standard care Pulmonary rehabilitation will be given alongside cognitive behavioural therapy
Experimental: PR+CBT+PA Promotion.
Standard care Pulmonary rehabilitation will be given alongside cognitive behavioural therapy and physical activity promotion.
Behavioral: Physical Activity Promotion
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.




Primary Outcome Measures :
  1. Patient compliance with the physical activity promotion intervention [ Time Frame: 8 weeks (16 sessions) ]
    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.


Secondary Outcome Measures :
  1. Change in daily physical activity. [ Time Frame: Measured 1 week prior and 1 week post rehabilitation ]
    Measured via steps/day using a triaxial accelerometer

  2. Change in symptoms of anxiety and depression. [ Time Frame: Measured 1 week prior and 1 week post rehabilitation ]

    Assessed using the Hospital Anxiety and Depression Scale (HADS) questionnaire. Scale measures for Anxiety and Depression are both out of 21. Scoring is grouped as: Normal= 0-7, Borderline abnormal= 8-10, 11-21= Abnormal.

    For the investigators study a score for Anxiety and/or depression of >8 is required at inclusion.


  3. Change in functional capacity [ Time Frame: Measured 1 week prior and 1 week post rehabilitation ]
    Assessed by the 6-min walk test

  4. Change in quality of life [ Time Frame: Measured 1 week prior and 1 week post rehabilitation ]
    Assessed using St Georges Respiratory Questionnaire (StGRQ). A total score is calculated, expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.

  5. Change in quality of life [ Time Frame: Measured 1 week prior and 1 week post rehabilitation ]
    Assessed using the clinical COPD questionnaire (CCQ). The total CCQ score is calculated by adding the scores of the ten items and dividing that number by 10. The scale varies between 0 (very good health) to 6 (extremely poor health status).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03749655


Contacts
Layout table for location contacts
Contact: Matthew G Armstrong, MS.c. 0191568426 matthew.armstrong@northumbria.ac.uk
Contact: Karen Heslop-Marshell, Ph.D. 07753884774 Karen.Heslop@nuth.nhs.uk

Locations
Layout table for location information
United Kingdom
Newcastle upon Tyne NHS trust Recruiting
Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE18ST
Contact: Karen Heslop-Marshall, Ph.D.    07753884774    Karen.Heslop@nuth.nhs.uk   
Contact: Matthew Armstrong, MS.c    07495155142    matthew.armstrong@northumbria.ac.uk   
Sub-Investigator: Ioannis Vogiatzis, Ph.D.         
Sponsors and Collaborators
Northumbria University
Newcastle-upon-Tyne Hospitals NHS Trust
  Study Documents (Full-Text)

Documents provided by Northumbria University:
Study Protocol and Informed Consent Form  [PDF] September 24, 2018


Publications:

Layout table for additonal information
Responsible Party: Northumbria University
ClinicalTrials.gov Identifier: NCT03749655     History of Changes
Other Study ID Numbers: 08968
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Northumbria University:
Pulmonary Rehabilitation
Physical activity
Anxiety and depression
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases