Behavioral Intervention to Maintain Physical Capacity and Activity in Patients With Chronic Obstructive Pulmonary Disease (COPD) (COPD)
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ClinicalTrials.gov Identifier: NCT01539434 |
Recruitment Status
:
Recruiting
First Posted
: February 27, 2012
Last Update Posted
: May 19, 2017
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Condition or disease | Intervention/treatment | Phase |
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Pulmonary Disease, Chronic Obstructive | Behavioral: Behavioural intervention Behavioral: Usual care group | Phase 2 |
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 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 |
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.
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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:
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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.
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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:
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- Six-minute walking distance [ Time Frame: Change from baseline and 6 months and up to 24 months ]Change in six-minute walking distance
- 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
- Short Form 36 [ Time Frame: Change from baseline and 6 months and up to 24 months ]Measures health related quality of life
- Chronic Respiratory Disease Questionnaire [ Time Frame: Change from baseline and 6 months and up to 24 months ]Measures health related quality of life
- Hospital anxiety and depression scale [ Time Frame: Change from baseline and 6 months and up to 24 months ]Measures anxiety and depression
- Grippit [ Time Frame: Change from baseline and 6 months and up to 24 months ]Hand muscle strength

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Ages Eligible for Study: | 40 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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): NCT01539434
Contact: Margareta Emtner, PhD | +46184714761 | margareta.emtner@neuro.uu.se |
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 |
Principal Investigator: | Margareta Emtner, PhD | Uppsala University | |
Study Chair: | Karin Wadell, PhD | Umeå University |
Responsible Party: | Uppsala University |
ClinicalTrials.gov Identifier: | NCT01539434 History of Changes |
Other Study ID Numbers: |
UOU-2012-MEKW |
First Posted: | February 27, 2012 Key Record Dates |
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 |