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

NCT01539434 | Unknown Phase 2 DMC

• 1 other identifier: UOU-2012-MEKW
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

COPD; Behavioral intervention; Physical capacity; Physical activity

Outcome Measures

Primary Outcomes (1)

• Six-minute walking distance

  Change in six-minute walking distance

  Change from baseline and 6 months and up to 24 months

Secondary Outcomes (5)

• Physical activity level

  Change from baseline and 6 months and up to 24 months

• Short Form 36

  Change from baseline and 6 months and up to 24 months

• Chronic Respiratory Disease Questionnaire

  Change from baseline and 6 months and up to 24 months

• Hospital anxiety and depression scale

  Change from baseline and 6 months and up to 24 months

• Grippit

  Change from baseline and 6 months and up to 24 months

Study Arms (2)

Behavioural intervention

EXPERIMENTAL

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

Usual care group

ACTIVE COMPARATOR

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

Behavioural intervention 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.

Also known as: Physical capacity, Physical activity

Behavioural intervention

Usual care group 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.

Also known as: Physical capacity, Physical activity

Usual care group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with COPD at Uppsala and Umeå university hospitals, who have participated in physical training at the hospital for 12 weeks.
• Diagnose of COPD

You may not qualify if:

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

Sponsors & Collaborators

• Uppsala University: lead
• Umeå University: collaborator

Study Sites (1)

Uppsala University

Uppsala, 75124, Sweden

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Margareta Emtner, PhD

  Uppsala University

  PRINCIPAL INVESTIGATOR

• Karin Wadell, PhD

  Umeå University

  STUDY CHAIR

Central Study Contacts

Margareta Emtner, PhD

CONTACT

+46184714761; margareta.emtner@neuro.uu.se

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2012
• First Posted: February 27, 2012
• Study Start: September 1, 2010
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2020
• Last Updated: May 19, 2017

Record last verified: 2017-05

Locations

SE (1)