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Behavioral Intervention to Maintain Physical Capacity and Activity in Patients With Chronic Obstructive Pulmonary Disease (COPD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2012 by Uppsala University
Sponsor:
Collaborator:
Umeå University
Information provided by (Responsible Party):
Uppsala University
ClinicalTrials.gov Identifier:
NCT01539434
First received: February 8, 2012
Last updated: February 24, 2012
Last verified: February 2012

February 8, 2012
February 24, 2012
September 2010
December 2014   (final data collection date for primary outcome measure)
Six-minute walking distance [ Time Frame: Change from baseline and 6 months and up to 24 months ] [ Designated as safety issue: No ]
Change in six-minute walking distance
Same as current
Complete list of historical versions of study NCT01539434 on ClinicalTrials.gov Archive Site
  • Physical activity level [ Time Frame: Change from baseline and 6 months and up to 24 months ] [ Designated as safety issue: No ]
    Number of steps, energy expenditure, time in different positions
  • Short Form 36 [ Time Frame: Change from baseline and 6 months and up to 24 months ] [ Designated as safety issue: No ]
    Measures health related quality of life
  • Chronic Respiratory Disease Questionnaire [ Time Frame: Change from baseline and 6 months and up to 24 months ] [ Designated as safety issue: No ]
    Measures health related quality of life
  • Hospital anxiety and depression scale [ Time Frame: Change from baseline and 6 months and up to 24 months ] [ Designated as safety issue: No ]
    Measures anxiety and depression
  • Grippit [ Time Frame: Change from baseline and 6 months and up to 24 months ] [ Designated as safety issue: No ]
    Hand muscle strength
Same as current
Not Provided
Not Provided
 
Behavioral Intervention to Maintain Physical Capacity and Activity in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Behavioral Medicine Intervention to Maintain Physical Capacity and Level of Physical Activity in Patients With Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is to investigate to what extent patients with COPD, who have participated in physical training for 12 weeks, can maintain their physical activity behaviour and physical capacity on a long-term basis if they get a behavioural medicine intervention.

Chronic Obstructive Pulmonary Disease (COPD) is a progressive disease and the number of patients is increasing. Persons with COPD have a low physical capacity and a low physical activity level. The risk of premature morbidity and mortality is high especially in persons with a low level of physical capacity and activity. Rehabilitation including physical training is recommended and results in decreased morbidity and mortality and increased physical capacity and quality of life. Unfortunately improvements decrease if patients do not maintain their physical activity level.

To change physical activity behaviour in is challenging. Different methods as Social Cognitive Theory, SCT and the Transtheoretical model, TTM have been suggested as theoretical framework. According to SCT, to improve physical activity behaviour you should use goal-setting, outcome expectancy, self-efficacy, and self-monitoring.

To use motivational interviewing (MI) improves the success of a behaviour change.

Patients will be randomized after the 12-week training period, tested, and thereafter both the intervention group and the control group will get information about the importance of physical activity and the recommendations.

Thereafter patients in the intervention group will receive weekly telephone calls for the first month, telephone calls every second week for the following two months and thereafter monthly telephone calls for the following three months. The telephone calls will be in accordance with MI and discuss goal-setting, out-come expectancy, and self-monitoring.

Patients will be tested after 6,12,and 24 months.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Pulmonary Disease, Chronic Obstructive
  • Behavioral: Behavioural intervention
    Patients in the behavioural intervention group will get a personal meeting with the physiotherapist and get advice about the value of physical activity and also get recommendations on how to be physically active. The behavioural intervention to support physical activity behaviour includes weekly motivational interviewing telephone calls for the first month, two telephone calls for the following two months and thereafter monthly telephone calls.
    Other Names:
    • Physical capacity
    • Physical activity
  • Behavioral: Usual care group
    Patients in the usual care group will get a personal meeting with the physiotherapist and get advice about the value of physical activity and also get recommendations on how to be physically active.
    Other Names:
    • Physical capacity
    • Physical activity
  • Experimental: Behavioural intervention
    Patients in the behavioural intervention group will get a personal meeting with the physiotherapist and get advice about the value of physical activity and also get recommendations on how to be physically active. The behavioural intervention to support physical activity behaviour includes weekly motivational interviewing telephone calls for the first month, two telephone calls for the following two months and thereafter monthly telephone calls.
    Intervention: Behavioral: Behavioural intervention
  • Active Comparator: Usual care group
    Patients in the usual care group will get a personal meeting with the physiotherapist and get advice about the value of physical activity and also get recommendations on how to be physically active.
    Intervention: Behavioral: Usual care group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with COPD at Uppsala and Umeå university hospitals, who have participated in physical training at the hospital for 12 weeks.
  • Diagnose of COPD

Exclusion criteria:

  • Understand the Swedish language
  • Be able to be physically active
Both
40 Years to 80 Years
No
Contact: Margareta Emtner, PhD +46184714761 margareta.emtner@neuro.uu.se
Sweden
 
NCT01539434
UOU-2012-MEKW
Yes
Uppsala University
Uppsala University
Umeå University
Principal Investigator: Margareta Emtner, PhD Uppsala University
Study Chair: Karin Wadell, PhD Umeå University
Uppsala University
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP