Pulmonary Disease, Chronic ObstructiveNCT03086590
EVALUATION OF RESPIRATORY MECHANICS AND FUNCTIONALITY IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE
An observational study of Pulmonary Disease, Chronic Obstructive, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
To associate a lean mass, peripheral muscle strength, kinematic thoracic-abdominal, respiratory metabolic response, mobility and diaphragmatic thickness, verifying its relation with the obstruction level of COPD Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Nov 2016to 1 Mar 2018
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with Chronic Obstructive Pulmonary Disease, selected at the Hospital das Clínicas of the Federal University of Pernambuco, Hospital Otávio de Freitas and Pharmacy of the State of Pernambuco.
Who may be able to join
- Young adults, adults and elderly subjects
Who cannot join
- Others respiratory diseases;
- Heart diseases;
- Those who are in some previous training program or rehabilitation;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BODY COMPOSITION, PERIPHERAL MUSCULAR FORCE, KINEMATIC THORACIC-ABDOMINAL, VENTILATORY METABOLIC RESPONSE, DIAPHRAGM MOBILITY AND THICKNESS PREDICTION OF OBSTRUCTION LEVEL OF COPD?
To associate a lean mass, peripheral muscle strength, kinematic thoracic-abdominal, respiratory metabolic response, mobility and diaphragmatic thickness, verifying its relation with the obstruction level of COPD
Read the detailed description
Individuals with COPD present restriction in their daily lives due to changes and bodily disorders promoted by the disease, such as changes in types of muscle fibers and chronic inflammatory process, causing a low level of physical activity and quality of life, besides being closely Related to the need for hospitalizations and increased mortality. A cross-sectional study with a convenience sample was performed at the Laboratory of Cardiopulmonary Physiotherapy of the Federal University of Pernambuco during the period from December 2016 to February 2018. As measurements of body composition were performed with a bio-balance scale, Evaluation of the peripheral muscle strength will be used the dynamometer, a load cell and electromyography, a kinematic thoracic-abdominal will be measured by optoelectronic plethysmography, a respiratory metabolic response will be verified during the 6-minute walk test using the gas analyzer, and for evaluation of mobility and diaphragmatic thickness are used on ultrasound associated with pneumotachograph.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Body composition, Ultrasound, Chronic Pulmonary Obstructive Disease, Respiratory muscles
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | COPD mild. The individuals allocated to this group have FEV1 ≥ 80% predicted. | |
| Group 2 | COPD Moderate. The individuals allocated to this group have 50% ≤ FEV1 < 80% predicted. | |
| Group 3 | COPD Severe. The individuals allocated to this group have 30% ≤ FEV1 < 50% predicted. | |
| Group 4 | COPD Very severe. The individuals allocated to this group have FEV1 < 30% predicted. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat-free mass
Mass of the human body disregarding fat.
Measured: Baseline
Quadriceps Force
Quadriceps muscle strength measured during maximum voluntary contraction.
Measured: Baseline
Handgrip strength
Maximum voluntary manual holding force.
Measured: Baseline
Total chest wall volume
Total volume resulting from the sum of the volume of the pulmonary compartment of the costal, abdominal gradient of the costal and abdominal beds.
Measured: Baseline
Oxygen uptake
Consumption of oxygen during an effort.
Measured: Baseline
Diaphragm mobility
It is the diaphragmatic movement from the end of the expiration until the end of the inspiration, being able to be realized in tidal volume or starting from the total pulmonary capacity.
Measured: Baseline
Diaphragm thickness
Defined as a corpulence of the diaphragm muscle
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start1 Nov 2016
- Primary completion1 Feb 2018
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo Viana Correia de Souza, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03086590
- Sponsor's protocol ID
- UFPE-M1
- Status last verified
- Nov 2018
- First submitted
- 9 Mar 2017
- Last updated
- 7 Nov 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BODY COMPOSITION, PERIPHERAL MUSCULAR FORCE, KINEMATIC THORACIC-ABDOMINAL, VENTILATORY METABOLIC RESPONSE, DIAPHRAGM MOBILITY AND THICKNESS PREDICTION OF OBSTRUCTION LEVEL OF COPD?
- ClinicalTrials.gov ID
- NCT03086590
- Acronym / sponsor ID
- UFPE-M1
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Body composition, Ultrasound, Chronic Pulmonary Obstructive Disease, Respiratory muscles
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 22 Mar 2017 (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.
To associate a lean mass, peripheral muscle strength, kinematic thoracic-abdominal, respiratory metabolic response, mobility and diaphragmatic thickness, verifying its relation with the obstruction level of COPD
Detailed description
Individuals with COPD present restriction in their daily lives due to changes and bodily disorders promoted by the disease, such as changes in types of muscle fibers and chronic inflammatory process, causing a low level of physical activity and quality of life, besides being closely Related to the need for hospitalizations and increased mortality. A cross-sectional study with a convenience sample was performed at the Laboratory of Cardiopulmonary Physiotherapy of the Federal University of Pernambuco during the period from December 2016 to February 2018. As measurements of body composition were performed with a bio-balance scale, Evaluation of the peripheral muscle strength will be used the dynamometer, a load cell and electromyography, a kinematic thoracic-abdominal will be measured by optoelectronic plethysmography, a respiratory metabolic response will be verified during the 6-minute walk test using the gas analyzer, and for evaluation of mobility and diaphragmatic thickness are used on ultrasound associated with pneumotachograph.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –COPD mild. The individuals allocated to this group have FEV1 ≥ 80% predicted. |
| Group 2 | – | –COPD Moderate. The individuals allocated to this group have 50% ≤ FEV1 < 80% predicted. |
| Group 3 | – | –COPD Severe. The individuals allocated to this group have 30% ≤ FEV1 < 50% predicted. |
| Group 4 | – | –COPD Very severe. The individuals allocated to this group have FEV1 < 30% predicted. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with Chronic Obstructive Pulmonary Disease, selected at the Hospital das Clínicas of the Federal University of Pernambuco, Hospital Otávio de Freitas and Pharmacy of the State of Pernambuco.
Key inclusion criteria (1 listed)
- Young adults, adults and elderly subjects
Key exclusion criteria (3 listed)
- Others respiratory diseases;
- Heart diseases;
- Those who are in some previous training program or rehabilitation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fat-free mass
Time frame: Baseline
Mass of the human body disregarding fat.
Quadriceps Force
Time frame: Baseline
Quadriceps muscle strength measured during maximum voluntary contraction.
Handgrip strength
Time frame: Baseline
Maximum voluntary manual holding force.
Total chest wall volume
Time frame: Baseline
Total volume resulting from the sum of the volume of the pulmonary compartment of the costal, abdominal gradient of the costal and abdominal beds.
Oxygen uptake
Time frame: Baseline
Consumption of oxygen during an effort.
Diaphragm mobility
Time frame: Baseline
It is the diaphragmatic movement from the end of the expiration until the end of the inspiration, being able to be realized in tidal volume or starting from the total pulmonary capacity.
Diaphragm thickness
Time frame: Baseline
Defined as a corpulence of the diaphragm muscle
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 7 Nov 2018.
Related trials for Pulmonary Disease, Chronic Obstructive
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
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 Pulmonary Disease, Chronic Obstructive, run by Universidade Federal de Pernambuco at 1 site in Brazil.
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 1 inclusion and 3 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 7 Nov 2018. 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 Brazil. 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?
Fat-free mass (time frame: Baseline). The study lists 7 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 7 Nov 2018.