NCT03084874

Brief Summary

Patients with COPD are more inactive and more sedentary than subjects of the same age and patients with other chronic diseases. This inactivity and sedentary behavior is accentuated after hospitalizations due to a COPD exacerbation, and it increases the risk for future hospitalizations and mortality. Therefore, there is a need for intervention to promote physical activity and to reduce sedentary behavior after these events. The present study aims to evaluate the efficacy of a coaching program to promote physical activity and reduce sedentary behavior in patients with COPD who have suffered a hospitalization due to a COPD exacerbation. Sixty-six COPD patients admitted to the hospital will be recruited during 18 months. Physical activity, sedentary behaviors, as well as other clinical and functional parameters will be evaluated after hospital discharge. Patients will be then randomized to an intervention and control group (1:1). The intervention group will receive an individualized coaching program. During a motivational interview an experienced physiotherapist will asses participant's usual exercise habits, possible barriers and facilitators, self-efficacy and motivation to increase physical activity and reduce sedentary time. Based on these data (and baseline physical activity/sedentary information) an individualized, progressive program with specific goals setting and self-monitoring will be established (patients will be active participants and decision makers in this process). The control group will receive the usual care during follow-up. Physical activity, sedentary behaviors, as well as the clinical and functional variables will be evaluated again at 12 weeks in both patients' groups.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 21, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 21, 2017

Status Verified

March 1, 2017

Enrollment Period

1.5 years

First QC Date

March 14, 2017

Last Update Submit

March 14, 2017

Conditions

Chronic Obstructive Pulmonary DiseasePhysical ActivitySedentary Lifestyle

Keywords

COPDPhysical ActivitySedentary behaviourHospitalization

Outcome Measures

Primary Outcomes (5)

  • Change in steps per day

    Steps per day will be objectively measured with an accelerometer

    Baseline and 12 weeks

  • Change in the number of active periods per day

    Number of periods spent standing, walking or shuffling objectively measured with an accelerometer

    Baseline and 12 weeks

  • Change in time spend in light and moderate physical activity

    Time spend in light and moderate physical activity (1.5-3 and 3-6 METS) objectively measured with an accelerometer

    Baseline and 12 weeks

  • Change in time spend in sedentary behavior

    Time spend in sedentary behavior (sitting or lying) objectively measured with an accelerometer

    Baseline and 12 weeks

  • Breaks in sedentary behaviour

    Number of transitions from sedentary behavior to standing or walking objectively measured with an accelerometer

    Baseline and 12 weeks

Secondary Outcomes (3)

  • Change in exercise capacity

    Baseline and 12 weeks

  • Change in muscle force

    Baseline and 12 weeks

  • Change in patient's quality of life

    Baseline and 12 weeks

Other Outcomes (2)

  • Change in patients's anxiety and depression

    Baseline and 12 weeks

  • Change in dyspnoea during daily activities

    Baseline and 12 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

Patients in the intervention group will receive an individualized coaching program to increase physical activity and reduce sedentary behavior during 12 weeks

Behavioral: Physical activity and sedentary behavior coaching program

Control group

NO INTERVENTION

Patients in the control group will receive the standard care for patients with COPD during 12 weeks.

Interventions

Physical activity and sedentary behavior coaching programBEHAVIORAL

The intervention group will receive an individualized coaching program. During a motivational interview an experienced physiotherapist will asses participant's usual exercise habits, possible barriers and facilitators, self-efficacy and motivation to increase physical activity and reduce sedentary time. Based on these data (and baseline physical activity/sedentary information) an individualized, progressive program with specific goals setting and self-monitoring will be established (patients will be active participants and decision makers in this process).

Intervention group

Eligibility Criteria

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

You may qualify if:

  • Previous diagnosis of COPD according to spirometric criteria (post-bronchodilator FEV1 / FVC less than 70%)
  • Smoking exposure\> 10 paq/year.
  • Age greater than 40 years.
  • Hospitalization due to a COPD exacerbation
  • Written informed consent.

You may not qualify if:

  • Patients needing the care of an Intensive Care Unit.
  • Patients who have been hospitalized more than once for a COPD exacerbation in the previous 12 months (at least 3 months from last discharge).
  • Patients with continuous oxygen therapy who do not have a portable source before admission.
  • Patients with severe hypoxemia at rest (SpO2 \<85% at rest) at discharge
  • Mental incapacity, severe comorbidity, general fragility or advanced age that could substantially difficult patient's participation in the study.
  • Patients who need mechanical aids for walking.
  • Patients participating in a pulmonary rehabilitation program.
  • Difficulty understanding Spanish / Catalan.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Vall d'Hebron

Barcelona, Spain

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveMotor ActivitySedentary Behavior

Interventions

Exercise

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Maria A Ramon, PT, PhD

CONTACT

0034932746107maramon@vhebron.net

Esther Rodriguez, MD, PhD

CONTACT

0034932746083estherod@vhebron.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2017

First Posted

March 21, 2017

Study Start

March 1, 2017

Primary Completion

September 1, 2018

Study Completion

December 1, 2018

Last Updated

March 21, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

IPD will not be shared

Locations

ES(1)