NCT02223962

Brief Summary

Severe exacerbations are prevalent in a subgroup of patients with COPD and generally warrant a hospitalization. During the hospitalization, patients are extremely physically inactive with only a limited recovery one month after discharge. Physical inactivity is associated with negative health benefits. Therefore intervening in the period after and exacerbation seems useful to improve the levels of physical activity. Physical activity counseling and real-time feedback have already been applied in stable patients with COPD, with beneficial effects.The present study will investigate whether this specific intervention will help to improve the activity level in patients after an acute exacerbation. Further we investigated the effects of the intervention on improvements in functional exercise capacity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 22, 2014

Completed
Last Updated

May 1, 2015

Status Verified

April 1, 2015

Enrollment Period

1.1 years

First QC Date

September 4, 2013

Last Update Submit

April 30, 2015

Conditions

COPD Exacerbation

Keywords

physical activityCOPDactivity monitors

Outcome Measures

Primary Outcomes (1)

  • Improvement in physical activity

    The Dynaport MoveMonitor, a valid device in patients with COPD, was used to accurately measure the level of physical activity. The device was provided 3 times to the patients (baseline, after 2 weeks, after 1 month). The amount of steps, measured by this device, was used as the outcome measure.

    1 month

Secondary Outcomes (1)

  • Improvement in functional exercise capacity

    1 month

Study Arms (2)

Physical activity

EXPERIMENTAL

The fitbit Ultra was used to provide real-time feedback on physical activity. An experienced physiotherapist contacted the subjects 3 times a week to receive information about the amount of steps from the previous days. In agreement with the patient, a new goal for the coming weeks was set and patients were motivated to achieve their individual goal.

Behavioral: Physical activity

Usual Care

PLACEBO COMPARATOR

During the hospital stay, the patients in the control group will be informed about the beneficial effects of being physically inactive.They will not receive feedback about their activities performed and will not be stimulated to become more active.

Behavioral: Physical activity

Interventions

Physical activityBEHAVIORAL

Counseling about physical activity will only be provided in the intervention group by 3 weekly telephone contacts. Based on the information the physiotherapist receives, he or she will adapt the goal (in agreement with the patient) and motivate the patient to reach the individual goal.

Physical activityUsual Care

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed Informed Consent
  • Chronic Obstructive Lung Disease (Tiff\<70%)
  • Hospitalized because of exacerbation
  • Capable of working with electronic devices

You may not qualify if:

  • Orthopedic/Neurologic problems making it difficult to be active
  • Participation in a rehabilitation program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Leuven

Leuven, 3000, Belgium

Location

Related Publications (1)

  • Hornikx M, Demeyer H, Camillo CA, Janssens W, Troosters T. The effects of a physical activity counseling program after an exacerbation in patients with Chronic Obstructive Pulmonary Disease: a randomized controlled pilot study. BMC Pulm Med. 2015 Nov 4;15:136. doi: 10.1186/s12890-015-0126-8.

    PMID: 26530543DERIVED

MeSH Terms

Conditions

Motor ActivityPulmonary Disease, Chronic Obstructive

Interventions

Exercise

Condition Hierarchy (Ancestors)

BehaviorLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

September 4, 2013

First Posted

August 22, 2014

Study Start

March 1, 2013

Primary Completion

April 1, 2014

Study Completion

May 1, 2014

Last Updated

May 1, 2015

Record last verified: 2015-04

Locations

BE(1)