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

Phase 2

• Conditions: Pulmonary Disease, Chronic Obstructive

• Registration Number: NCT01539434
• Lead Sponsor: Uppsala University

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.

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2012-02-08
• Study First Submitted QC: 2012-02-24
• Study First Posted: 2012-02-27
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-18
• Last Update Posted: 2017-05-19
• Primary Completion: 2018-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Six-minute walking distance	Change from baseline and 6 months and up to 24 months	Change in six-minute walking distance

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Uppsala University; 🇸🇪 Uppsala, Sweden