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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Pulmonary Disease, Chronic Obstructive	Behavioral: Behavioural intervention; Behavioral: Usual care group	Phase 2

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.

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	100 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (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)
Actual Study Start Date :	September 2010
Estimated Primary Completion Date :	December 2018
Estimated Study Completion Date :	December 2020

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Six-minute walking distance [ Time Frame: Change from baseline and 6 months and up to 24 months ]
   Change in six-minute walking distance

Secondary Outcome Measures :

1. Physical activity level [ Time Frame: Change from baseline and 6 months and up to 24 months ]
   Number of steps, energy expenditure, time in different positions
2. Short Form 36 [ Time Frame: Change from baseline and 6 months and up to 24 months ]
   Measures health related quality of life
3. Chronic Respiratory Disease Questionnaire [ Time Frame: Change from baseline and 6 months and up to 24 months ]
   Measures health related quality of life
4. Hospital anxiety and depression scale [ Time Frame: Change from baseline and 6 months and up to 24 months ]
   Measures anxiety and depression
5. Grippit [ Time Frame: Change from baseline and 6 months and up to 24 months ]
   Hand muscle strength

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	40 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Uppsala University
ClinicalTrials.gov Identifier:	NCT01539434 History of Changes
Other Study ID Numbers:	UOU-2012-MEKW
First Posted:	February 27, 2012
Last Update Posted:	May 19, 2017
Last Verified:	May 2017

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