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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Behavioral Medicine Intervention to Maintain Physical Capacity and Level of Physical Activity in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Behavioral: Behavioural intervention
* Behavioral: Usual care group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioural intervention<br>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<br>* 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.<br>* Other names: Physical activity;|
| Active Comparator: Usual care group<br>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<br>* 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.<br>* Other names: Physical activity;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six-minute walking distance | Change in six-minute walking distance | Change from baseline and 6 months and up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity level | Number of steps, energy expenditure, time in different positions | Change from baseline and 6 months and up to 24 months | 
| Short Form 36 | Measures health related quality of life | Change from baseline and 6 months and up to 24 months | 
| Chronic Respiratory Disease Questionnaire | Measures health related quality of life | Change from baseline and 6 months and up to 24 months | 
| Hospital anxiety and depression scale | Measures anxiety and depression | Change from baseline and 6 months and up to 24 months | 
| Grippit | Hand muscle strength | Change from baseline and 6 months and up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Behavioral intervention, Physical capacity, Physical activity