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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04726384
Other study ID # OpoleUofTech2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2020
Est. completion date January 8, 2021

Study information

Verified date January 2021
Source The Opole University of Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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. Patients participated in pulmonary rehabilitation program consisted of: - specific respiratory exercises for 30 minutes - relaxation exercises for breathing muscles, strengthening exercises the diaphragm with resistance, exercises to increase costal or chest breathing, prolonged exhalation exercise, chest percussion, once a day for 30 min, - training on a cycle ergometer, twice a day for 20-30 min.- until the Heart Rate reaches 70% of the HRmax (220-age), - fitness exercises - coordination and balance exercises, stretching exercises using elastic bands, balls rehabilitation, sensory pillows. Performed in a standing position, kneeling, sitting, lying on side, abdomen and back, once a day for 30 min - Schultz autogenic training, once a day 20 min.


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date January 8, 2021
Est. primary completion date October 8, 2020
Accepts healthy volunteers No
Gender All
Age group 50 Years to 80 Years
Eligibility Inclusion Criteria: - Diagnosed COPD; - Agreement to participate in the study Exclusion Criteria: - 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;

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Assessment of physical activity level
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.

Locations

Country Name City State
Poland Hospital of Ministry of the Interior and Administration Glucholazy Opolskie

Sponsors (1)

Lead Sponsor Collaborator
The Opole University of Technology

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary Number of steps The SenseWear Armband was used to assess number of steps up to 4 days
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