Chronic Obstructive Pulmonary DiseaseNCT04726384
Physical Activity Level of Patients With COPD During Pulmonary Rehabilitation
An observational study of Chronic Obstructive Pulmonary Disease, run by The Opole University of Technology at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Assessment of physical activity level
- Type of treatment
- Medical device
- How many people
- 13 participants
- Where
- 1 sitePoland
- Study dates
- 1 Oct 2020to 8 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with chronic obstructive pulmonary disease participating in a 3-week hospital-based pulmonary rehabilitation program
Who may be able to join
- Diagnosed COPD;
- Agreement to participate in the study
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
Poland1 site
Hospital of Ministry of the Interior and Administration
Głuchołazy, Opole Voivodeship, 48-340
About this study
Official title: Physical Activity Level of Patients With COPD During In-hospital Pulmonary Rehabilitation: a Pilot Study
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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Assessment of physical activity level
- Keywords
- COPD, Physical Activity, SenseWear Armband
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of physical activity levelDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Assessment of physical activity level |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: up to 4 days
Number of steps
The SenseWear Armband was used to assess number of steps
Measured: up to 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start1 Oct 2020
- Primary completion8 Oct 2020
- Study completion8 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Opole University of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04726384
- Sponsor's protocol ID
- OpoleUofTech2
- Status last verified
- Jan 2021
- First submitted
- 21 Jan 2021
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity Level of Patients With COPD During In-hospital Pulmonary Rehabilitation: a Pilot Study
- ClinicalTrials.gov ID
- NCT04726384
- Acronym / sponsor ID
- OpoleUofTech2
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Physical Activity, SenseWear Armband
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- The Opole University of TechnologyUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 8 Oct 2020 (actual)
- Study completion
- 8 Jan 2021 (actual)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observed group | – | Device: Assessment of physical activity levelThe 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 |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with chronic obstructive pulmonary disease participating in a 3-week hospital-based pulmonary rehabilitation program
Key inclusion criteria (2 listed)
- Diagnosed COPD;
- Agreement to participate in the study
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of physical activity levelPhysical 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. | Device | Observed group |
Primary outcome
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)
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
Number of steps
Time frame: up to 4 days
The SenseWear Armband was used to assess number of steps
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by The Opole University of Technology at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy expenditure - MET (time frame: up to 4 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.