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

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

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.

Study Overview

• Status: Unknown
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Behavioral: Behavioural intervention; Behavioral: Usual care group

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Sweden
  • Uppsala, Sweden, 75124
    • Recruiting
    • Uppsala University
    • Contact: Margareta Emtner, PhD; Phone Number: +46184714761; Email: margareta.emtner@neuro.uu.se
    • Contact: Christer Janson, Professor; Phone Number: +46704250441; Email: christer.janson@medsci.uu.se
    • Principal Investigator: Margareta Emtner, PhD
    • Sub-Investigator: Johanna Holmbäck, PT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: Physical activity; Physical capacity
Active Comparator: 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.	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.; Other Names: Physical activity; Physical capacity

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Uppsala University
• Collaborators: Umeå University
• Investigators: Principal Investigator: Margareta Emtner, PhD, Uppsala University; Study Chair: Karin Wadell, PhD, Umeå University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2010
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: February 8, 2012
• First Submitted That Met QC Criteria: February 24, 2012
• First Posted (Estimate): February 27, 2012

Study Record Updates

• Last Update Posted (Actual): May 19, 2017
• Last Update Submitted That Met QC Criteria: May 18, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: COPD; Physical activity; Behavioral intervention; Physical capacity
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: UOU-2012-MEKW