CClinicalTrials.gg
Status unknownNCT01539434COPDUpdated May 19, 2017

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

A Phase 2 interventional study of Behavioural intervention and Usual care group in Pulmonary Disease, Chronic Obstructive, sponsored by Uppsala University. Status unknown at 1 site in Sweden. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-05-19.

Sponsored by Uppsala University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2017), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 5 months after the study started (first participant enrolled Sep 2010, registered Feb 2012).
Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pulmonary Disease, Chronic Obstructive

Keywords

  • COPD
  • Behavioral intervention
  • Physical capacity
  • Physical activity
03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's planned enrollment of 100 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Uppsala University is the lead sponsor of 381 studies on the registry; 84 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion criteria:

  • Understand the Swedish language
  • Be able to be physically active
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • BehavioralBehavioural 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.

    Also known as: Physical capacity, Physical activity

  • BehavioralUsual 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.

    Also known as: Physical capacity, Physical activity

06

What researchers measure

Primary outcomes

  1. Six-minute walking distance

    Change in six-minute walking distance

    Time frame: Change from baseline and 6 months and up to 24 months

Secondary outcomes

  1. Physical activity level

    Number of steps, energy expenditure, time in different positions

    Time frame: Change from baseline and 6 months and up to 24 months

  2. Short Form 36

    Measures health related quality of life

    Time frame: Change from baseline and 6 months and up to 24 months

  3. Chronic Respiratory Disease Questionnaire

    Measures health related quality of life

    Time frame: Change from baseline and 6 months and up to 24 months

  4. Hospital anxiety and depression scale

    Measures anxiety and depression

    Time frame: Change from baseline and 6 months and up to 24 months

  5. Grippit

    Hand muscle strength

    Time frame: Change from baseline and 6 months and up to 24 months

07

Study locations

1 of 1 sites recruiting
  • Uppsala University
    Uppsala, 75124, Sweden
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01539434
Lead sponsor
Uppsala University
Collaborators
Umeå University
Responsible party
Sponsor
First posted
Feb 27, 2012
Start date
Sep 2010
Primary completion
Dec 2018 (estimated)
Completion
Dec 2020 (estimated)
Last update
May 19, 2017

Study contacts

Margareta Emtner, PhD
Contact
margareta.emtner@neuro.uu.se
+46184714761
Margareta Emtner, PhD
principal investigator · Uppsala University
Karin Wadell, PhD
study chair · Umeå University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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