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

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Unknown status
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Behavioural intervention
Usual care group
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring COPD, Behavioral intervention, Physical capacity, Physical activity

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Uppsala UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Behavioural intervention

Usual care group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Six-minute walking distance
Change in six-minute walking distance

Secondary Outcome Measures

Physical activity level
Number of steps, energy expenditure, time in different positions
Short Form 36
Measures health related quality of life
Chronic Respiratory Disease Questionnaire
Measures health related quality of life
Hospital anxiety and depression scale
Measures anxiety and depression
Grippit
Hand muscle strength

Full Information

First Posted
February 8, 2012
Last Updated
May 18, 2017
Sponsor
Uppsala University
Collaborators
Umeå University
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1. Study Identification

Unique Protocol Identification Number
NCT01539434
Brief Title
Behavioral Intervention to Maintain Physical Capacity and Activity in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Acronym
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

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uppsala University
Collaborators
Umeå University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
COPD, Behavioral intervention, Physical capacity, Physical activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Behavioural intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care group
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
Behavioural intervention
Other Intervention Name(s)
Physical capacity, Physical activity
Intervention Description
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
Intervention Name(s)
Usual care group
Other Intervention Name(s)
Physical capacity, Physical activity
Intervention Description
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.
Primary Outcome Measure Information:
Title
Six-minute walking distance
Description
Change in six-minute walking distance
Time Frame
Change from baseline and 6 months and up to 24 months
Secondary Outcome Measure Information:
Title
Physical activity level
Description
Number of steps, energy expenditure, time in different positions
Time Frame
Change from baseline and 6 months and up to 24 months
Title
Short Form 36
Description
Measures health related quality of life
Time Frame
Change from baseline and 6 months and up to 24 months
Title
Chronic Respiratory Disease Questionnaire
Description
Measures health related quality of life
Time Frame
Change from baseline and 6 months and up to 24 months
Title
Hospital anxiety and depression scale
Description
Measures anxiety and depression
Time Frame
Change from baseline and 6 months and up to 24 months
Title
Grippit
Description
Hand muscle strength
Time Frame
Change from baseline and 6 months and up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Margareta Emtner, PhD
Phone
+46184714761
Email
margareta.emtner@neuro.uu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margareta Emtner, PhD
Organizational Affiliation
Uppsala University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karin Wadell, PhD
Organizational Affiliation
Umeå University
Official's Role
Study Chair
Facility Information:
Facility Name
Uppsala University
City
Uppsala
ZIP/Postal Code
75124
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margareta Emtner, PhD
Phone
+46184714761
Email
margareta.emtner@neuro.uu.se
First Name & Middle Initial & Last Name & Degree
Christer Janson, Professor
Phone
+46704250441
Email
christer.janson@medsci.uu.se
First Name & Middle Initial & Last Name & Degree
Margareta Emtner, PhD
First Name & Middle Initial & Last Name & Degree
Johanna Holmbäck, PT

12. IPD Sharing Statement

Learn more about this trial

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

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