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

NCT ID: NCT01539434

Last Updated: 2017-05-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2020-12-31

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Behavioural intervention

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

Usual care group

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Physical capacity; Physical activity; Physical capacity; Physical activity

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Umeå University

OTHER

Sponsor Role: collaborator

Uppsala University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Margareta Emtner, PhD

Role: PRINCIPAL_INVESTIGATOR

Uppsala University

Karin Wadell, PhD

Role: STUDY_CHAIR

Umeå University

Locations

Uppsala University

Uppsala, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Margareta Emtner, PhD

Role: CONTACT

margareta.emtner@neuro.uu.se

+46184714761

Facility Contacts

Margareta Emtner, PhD

Role: primary

margareta.emtner@neuro.uu.se

+46184714761

Christer Janson, Professor

Role: backup

christer.janson@medsci.uu.se

+46704250441

Other Identifiers

UOU-2012-MEKW

Identifier Type: -

Identifier Source: org_study_id