ElderlyPhase 1/2NCT00768235
Yoga Program in Respiratory Function
A Phase 1/2 study testing yoga practice in people with Elderly, run by Catholic University of Brasília at 1 site in Brazil.
Trial summary
This study tested the hypothesis that yoga practice can improve respiratory function in the elderly. Read more about this study
- Who is it for?
- Ages 51 to 76 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Elderly
- What is being tested?
- yoga practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2007to Jun 2007
- Phase
- Phase 1/2
- 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 51 to 76 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sedentary women
Who cannot join
- Physical impairment
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Catholic university of brasilia
Brasília, Federal District, 71966-700
About this study
Official title: Influence of Yoga Program in Respiratory Function of Older Women
This study tested the hypothesis that yoga practice can improve respiratory function in the elderly.
Read the detailed description
Maximal inspiratory and expiratory pressure (IPmax and EPmax) were assessed by a manovacuometer and tidal volume (VT), vital capacity (VC) and minute ventilation (VE) were assessed by a ventilometer. The yoga program comprised 70 min sessions, 3 times/week during 12 weeks.
- Conditions
- Elderly
- Being tested
- yoga practice
- Keywords
- Sedentary elderly women that had medical assignment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
yoga practiceOther
The yoga program comprised 70 min sessions, 3 times/week during 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1: yoga group | Experimental | Yoga group Receives: Other: yoga practice |
| 2: control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal inspiratory and expiratory pressure (IPmax and EPmax) were assessed by a manovacuometer and tidal volume (VT), vital capacity (VC) and minute ventilation (VE) were assessed by a ventilometer
Measured: pre-intervention and post-intervention
Secondary outcomes (1)
Maximal inspiratory and expiratory pressure (IPmax and EPmax) were assessed by a manovacuometer and tidal volume (VT), vital capacity (VC) and minute ventilation (VE) were assessed by a ventilometer
Measured: pre-intervention and post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2008 (estimated)
- Study startMar 2007
- Primary completionMar 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ElderlyStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of Brasília
- Sponsor type
- University, hospital or other
- Investigators
- Lidia MA Bezerra, Ms., Principal investigator, catholic University of Brasilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00768235
- Sponsor's protocol ID
- UCByoga123
- Other IDs
- UCByoga12345
- Status last verified
- Oct 2008
- First submitted
- 7 Oct 2008
- Last updated
- 8 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Buchman AS, Boyle PA, Wilson RS, Leurgans S, Shah RC, Bennett DA. Respiratory muscle strength predicts decline in mobility in older persons. Neuroepidemiology. 2008;31(3):174-80. doi: 10.1159/000154930. Epub 2008 Sep 11.
PubMed 18784416
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Yoga Program in Respiratory Function of Older Women
- ClinicalTrials.gov ID
- NCT00768235
- Acronym / sponsor ID
- UCByoga123
- Conditions
- Elderly
- Keywords
- Sedentary elderly women that had medical assignment
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Catholic University of BrasíliaUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Mar 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 8 Oct 2008 (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.
This study tested the hypothesis that yoga practice can improve respiratory function in the elderly.
Detailed description
Maximal inspiratory and expiratory pressure (IPmax and EPmax) were assessed by a manovacuometer and tidal volume (VT), vital capacity (VC) and minute ventilation (VE) were assessed by a ventilometer. The yoga program comprised 70 min sessions, 3 times/week during 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: yoga group | Experimental | Other: yoga practiceYoga group |
| 2: control group | No intervention | – |
Who may qualify
- Ages
- 51 to 76 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Sedentary women
Key exclusion criteria (1 listed)
- Physical impairment
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 |
|---|---|---|
| yoga practiceThe yoga program comprised 70 min sessions, 3 times/week during 12 weeks | Other | 1: yoga group |
Primary outcome
Maximal inspiratory and expiratory pressure (IPmax and EPmax) were assessed by a manovacuometer and tidal volume (VT), vital capacity (VC) and minute ventilation (VE) were assessed by a ventilometer
Time frame: pre-intervention and post-intervention
1 secondary outcome
Maximal inspiratory and expiratory pressure (IPmax and EPmax) were assessed by a manovacuometer and tidal volume (VT), vital capacity (VC) and minute ventilation (VE) were assessed by a ventilometer
Time frame: pre-intervention and post-intervention
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 8 Oct 2008.
- Background: PubMed 18784416Buchman AS, Boyle PA, Wilson RS, Leurgans S, Shah RC, Bennett DA. Respiratory muscle strength predicts decline in mobility in older persons. Neuroepidemiology. 2008;31(3):174-80. doi: 10.1159/000154930. Epub 2008 Sep 11.
- articleLink provided by the sponsor.
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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.
Lidia MA Bezerra, Ms. principal investigator
catholic University of Brasilia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing yoga practice in people with Elderly, run by Catholic University of Brasília 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 1 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 8 Oct 2008. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Maximal inspiratory and expiratory pressure (IPmax and EPmax) were assessed by a manovacuometer and tidal volume (VT), vital capacity (VC) and minute ventilation (VE) were assessed by a ventilometer (time frame: pre-intervention and post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00768235, which also lists 1 linked publication.
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 8 Oct 2008.