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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Uppsala University.
Recruitment status was  Recruiting
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
History of Changes
  Purpose
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.

Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
 Behavioral: Behavioural intervention
Behavioral: Usual care group
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Behavioral Medicine Intervention to Maintain Physical Capacity and Level of Physical Activity in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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
Estimated Enrollment: 100
Study Start Date: September 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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
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.
 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

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01539434

Contacts
Contact: Margareta Emtner, PhD +46184714761 margareta.emtner@neuro.uu.se

Locations
Sweden
Uppsala University Recruiting
Uppsala, Sweden, 75124
Contact: Margareta Emtner, PhD    +46184714761    margareta.emtner@neuro.uu.se   
Contact: Christer Janson, Professor    +46704250441    christer.janson@medsci.uu.se   
Principal Investigator: Margareta Emtner, PhD         
Sub-Investigator: Johanna Holmbäck, PT         
Sponsors and Collaborators
Uppsala University
Umeå University
Investigators
Principal Investigator: Margareta Emtner, PhD Uppsala University
Study Chair: Karin Wadell, PhD Umeå University
  More Information

Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT01539434     History of Changes
Other Study ID Numbers: UOU-2012-MEKW 
Study First Received: February 8, 2012
Last Updated: February 24, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Uppsala University:
COPD
Behavioral intervention
Physical capacity
Physical activity

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
 Respiratory Tract Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 27, 2016