- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04726384
Physical Activity Level of Patients With COPD During Pulmonary Rehabilitation
Physical Activity Level of Patients With COPD During In-hospital Pulmonary Rehabilitation: a Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Opolskie
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Głuchołazy, Opolskie, Poland, 48-340
- Hospital of Ministry of the Interior and Administration
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Energy expenditure - MET
Time Frame: up to 4 days
|
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
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Energy expenditure - kcal
Time Frame: up to 4 days
|
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
Time Frame: up to 4 days
|
The SenseWear Armband was used to assess number of steps
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up to 4 days
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OpoleUofTech2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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