Clinical trial NCT01539434: Behavioral Intervention to Maintain Physical Capacity and Activity in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official title: Behavioral Medicine Intervention to Maintain Physical Capacity and Level of Physical Activity in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: COPD
Behavioral intervention
Physical capacity
Physical activity
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Umeå University
First posted: 2012-02-27
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Six-minute walking distance
timeFrame: Change from baseline and 6 months and up to 24 months
Secondary outcomes:
measure: Physical activity level
timeFrame: Change from baseline and 6 months and up to 24 months
measure: Short Form 36
timeFrame: Change from baseline and 6 months and up to 24 months
measure: Chronic Respiratory Disease Questionnaire
timeFrame: Change from baseline and 6 months and up to 24 months
measure: Hospital anxiety and depression scale
timeFrame: Change from baseline and 6 months and up to 24 months
measure: Grippit
timeFrame: Change from baseline and 6 months and up to 24 months
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University
Study officials:
affiliation: Uppsala University
name: Margareta Emtner, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Umeå University
name: Karin Wadell, PhD
role: STUDY_CHAIR
References: