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

Pulmonary Disease, Chronic Obstructive Clinical Trial

— COPD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01539434
• Other study ID #: UOU-2012-MEKW
• Status: Recruiting
• Phase: Phase 2
• First received: February 8, 2012
• Last updated: May 18, 2017
• Start date: September 2010
• Est. completion date: December 2020

Study information

• Verified date: May 2017
• Source: Uppsala University
• Contact: Margareta Emtner, PhD
• Phone: +46184714761
• Email: margareta.emtner[@]neuro.uu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2020
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.
• 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.

Locations

Country	Name	City	State
Sweden	Uppsala University	Uppsala

Sponsors (2)

Lead Sponsor	Collaborator
Uppsala University	Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Six-minute walking distance	Change in six-minute walking distance	Change from baseline and 6 months and up to 24 months
Secondary	Physical activity level	Number of steps, energy expenditure, time in different positions	Change from baseline and 6 months and up to 24 months
Secondary	Short Form 36	Measures health related quality of life	Change from baseline and 6 months and up to 24 months
Secondary	Chronic Respiratory Disease Questionnaire	Measures health related quality of life	Change from baseline and 6 months and up to 24 months
Secondary	Hospital anxiety and depression scale	Measures anxiety and depression	Change from baseline and 6 months and up to 24 months
Secondary	Grippit	Hand muscle strength	Change from baseline and 6 months and up to 24 months