SarcopeniaRMSNCT01912482
Cardiorespiratory Training and Ventilatory Muscle Strength
A study testing Cardiorespiratory training and ventilatory training in people with Sarcopenia, run by Universidade Gama Filho at 1 site in Brazil.
Trial summary
The cardiorespiratory training can increase muscle strength ventilatory. Read more about this study
- Who is it for?
- Ages 60 to 79 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Cardiorespiratory training and ventilatory training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2015to Dec 2016
- Phase
- Interventional
- 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 60 to 79 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have lower maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) values normative reference proposed by the Brazilian Society of Thoracic.
Who cannot join
- Not be voluntary to the present study.
- Conditions that oblige participants are absent for more than two weeks of activities performed in the experiment.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Gama Filho University
Rio de Janeiro, Rio de Janeiro, 23050-260
Fabio D Pereira, MSc, 552178705024, profabiodutra@hotmail.com
Elirez B Silva, Doctoral, 552125997170, elirezsilva@ugf.com
About this study
Official title: Chronic Effect of Cardiorespiratory Training on Ventilatory Muscle Strength in Elderly Women: Controlled Trial, Randomized and Double Blind.
The cardiorespiratory training can increase muscle strength ventilatory.
Read the detailed description
Specifically for being an experiment parallel factorial intervention after met the eligibility criteria for the participants will be randomly allocated to three groups: control, respiratory training, cardiorespiratory training (indoor Bike).
- Conditions
- Sarcopenia
- Being tested
- Cardiorespiratory training, ventilatory training
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiorespiratory trainingOther
Also called GTC
The cardiorespiratory training group will undergo 18 sessions, these also periodized in a maximum six weeks, respecting the minimum weekly frequency of 3 sessions.
ventilatory trainingOther
Also called GTV
The ventilatory training group will undergo 18 sessions, periodized in a maximum six weeks, respecting the minimum weekly frequency of three sessions.
| Study group | Role | What they receive |
|---|---|---|
| Cardiorespiratory training | Experimental | The cardiorespiratory training group will undergo 18 sessions, these also periodized in a maximum six weeks, respecting the minimum weekly frequency of 3 sessions. Receives: Other: Cardiorespiratory training |
| Ventilatory Training | Active comparator | The ventilatory training group will undergo 18 sessions, periodized in a maximum six weeks, respecting the minimum weekly frequency of three sessions. Receives: Other: ventilatory training |
| Crontrol Group | No intervention | This condition will last six weeks, this period will be held six lectures sixty minutes long and periodization weekly. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilatory muscle strength
The MIP and MEP are measured by a digital manometer 300(BRAZIL). During the measurement the participants should be seated in a chair type office allowing your upper body to remain in contact with the back of it, forming an angle of 90° to the hip, the arms extended along the body, knees flexed too 90° and feet flat on the floor. Participants will use a nose clip.
The evaluator will manually compress the face of the participant not allowing the contraction of the buccinator muscles increase intraoral pressure and interfere with the measurement result.
In the measurement of MIP participants should hold a maximum inspiration from residual volume (RV) and MEP maximum exhalation from total lung capacity (TLC).
Measured: The ventilatory muscle strength (MIP and MEP) will be measured after 18 cardiorespiratory training sessions held in 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2013 (estimated)
- Study startJul 2015
- Primary completionJun 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Gama Filho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabio Dutra Pereira, Universidade Gama Filho
- Investigators
- Fabio D Pereira, MSc, Principal investigator, Gama Filho University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01912482
- Sponsor's protocol ID
- BR20132014
- Acronym
- RMS
- Status last verified
- Jan 2015
- First submitted
- 3 Jun 2013
- Last updated
- 6 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Effect of Cardiorespiratory Training on Ventilatory Muscle Strength in Elderly Women: Controlled Trial, Randomized and Double Blind.
- ClinicalTrials.gov ID
- NCT01912482
- Acronym / sponsor ID
- RMS / BR20132014
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidade Gama FilhoUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 31 Jul 2013 (estimated)
- 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 cardiorespiratory training can increase muscle strength ventilatory.
Detailed description
Specifically for being an experiment parallel factorial intervention after met the eligibility criteria for the participants will be randomly allocated to three groups: control, respiratory training, cardiorespiratory training (indoor Bike).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cardiorespiratory training | Experimental | Other: Cardiorespiratory trainingThe cardiorespiratory training group will undergo 18 sessions, these also periodized in a maximum six weeks, respecting the minimum weekly frequency of 3 sessions. |
| Ventilatory Training | Active comparator | Other: ventilatory trainingThe ventilatory training group will undergo 18 sessions, periodized in a maximum six weeks, respecting the minimum weekly frequency of three sessions. |
| Crontrol Group | No intervention | –This condition will last six weeks, this period will be held six lectures sixty minutes long and periodization weekly. |
Who may qualify
- Ages
- 60 to 79 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Have lower maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) values normative reference proposed by the Brazilian Society of Thoracic.
Key exclusion criteria (2 listed)
- Not be voluntary to the present study.
- Conditions that oblige participants are absent for more than two weeks of activities performed in the experiment.
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 |
|---|---|---|
| Cardiorespiratory trainingAlso: GTCThe cardiorespiratory training group will undergo 18 sessions, these also periodized in a maximum six weeks, respecting the minimum weekly frequency of 3 sessions. | Other | Cardiorespiratory training |
| ventilatory trainingAlso: GTVThe ventilatory training group will undergo 18 sessions, periodized in a maximum six weeks, respecting the minimum weekly frequency of three sessions. | Other | Ventilatory Training |
Primary outcome
Ventilatory muscle strength
Time frame: The ventilatory muscle strength (MIP and MEP) will be measured after 18 cardiorespiratory training sessions held in 6 weeks.
The MIP and MEP are measured by a digital manometer 300(BRAZIL). During the measurement the participants should be seated in a chair type office allowing your upper body to remain in contact with the back of it, forming an angle of 90° to the hip, the arms extended along the body, knees flexed too 90° and feet flat on the floor. Participants will use a nose clip. The evaluator will manually compress the face of the participant not allowing the contraction of the buccinator muscles increase intraoral pressure and interfere with the measurement result. In the measurement of MIP participants should hold a maximum inspiration from residual volume (RV) and MEP maximum exhalation from total lung capacity (TLC).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2015.
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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.
Fabio D Pereira, MSc principal investigator
Gama Filho University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiorespiratory training and ventilatory training in people with Sarcopenia, run by Universidade Gama Filho 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 2 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: status not confirmed, as of the sponsor's last update on 6 Jan 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabio D Pereira, MSc (552178705024, profabiodutra@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilatory muscle strength (time frame: The ventilatory muscle strength (MIP and MEP) will be measured after 18 cardiorespiratory training sessions held in 6 weeks.). 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 6 Jan 2015.