NCT04726384

Brief Summary

The aim of the project was to assess the acceptability of the device as well as adherence to the study. The objective of study was to assess physical activity in patients with COPD during in-hospital pulmonary rehabilitation program. The number of steps, average energy expenditure expressed in MET and kcal, and physical activity time during the consecutive 5 days of the rehabilitation stay were analyzed. Physical activity level was continuously monitored to assess intensity during in-hospital procedures as well as during leisure time.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

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

October 1, 2020

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2021

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 27, 2021

Completed
Last Updated

January 27, 2021

Status Verified

January 1, 2021

Enrollment Period

7 days

First QC Date

January 21, 2021

Last Update Submit

January 26, 2021

Conditions

Keywords

COPDPhysical ActivitySenseWear Armband

Outcome Measures

Primary Outcomes (3)

  • Energy expenditure - MET

    The SenseWear Armband was used to assess energy expenditure. The device was used to measure energy expenditure expressed in metabolic equivalent (MET)

    up to 4 days

  • Energy expenditure - kcal

    The SenseWear Armband was used to assess energy expenditure. The device was used to measure energy expenditure expressed in kcal

    up to 4 days

  • Number of steps

    The SenseWear Armband was used to assess number of steps

    up to 4 days

Study Arms (1)

Observed group

The group was monitored for physical activity levels using the SenseWear Armband device. The group was informed of the purpose of the study and asked to wear the device 24 hours a day for the next 4 days (Friday-Monday) excluding bath time, no more than 30 minutes. Patients received the device on Thursday afternoon and returned it on Tuesday. However, the days Friday-Monday were analyzed to have a record of the entire days

Device: Assessment of physical activity level

Interventions

Physical activity was assessed using the Sensewear Armband device. Patients received the device on Thursday mornings, prior to exercise and treatments. The device was placed on the right arm throughout the study. Patients in whom the device monitored a minimum of 95% of the time of the study day were analyzed. Prior to the study, the devices were programmed to record a minimum level of intense (\>3MET) and moderate ( \>6MET) exercise.

Observed group

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with chronic obstructive pulmonary disease participating in a 3-week hospital-based pulmonary rehabilitation program

You may qualify if:

  • Diagnosed COPD;
  • Agreement to participate in the study

You may not qualify if:

  • Pneumonia, tuberculosis and other respiratory inflammatory disease in all stages and forms
  • Condition after a heart attack
  • Diabetes
  • State after thoracic and cardiac surgery
  • Heart failure (stage III, IV ° NYHA)
  • Advanced hypertension
  • Diseases and injuries that can impair the function of the musculoskeletal system of transportation
  • Disturbances of consciousness, psychotic symptoms or other serious psychiatric disorders;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of Ministry of the Interior and Administration

Głuchołazy, Opole Voivodeship, 48-340, Poland

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveMotor Activity

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2021

First Posted

January 27, 2021

Study Start

October 1, 2020

Primary Completion

October 8, 2020

Study Completion

January 8, 2021

Last Updated

January 27, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations