Frail Elderly SyndromeNCT03689322
Effects of WBV Associated With IMT on Inflammatory Markers, Body Composition, Muscle Strength and Thickness
A study testing WBV + IMT in people with Frail Elderly Syndrome, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
Aging generates immune, muscular and functional changes. In the pre-frail elderly these changes may be increased and, therefore, preventive interventions are indicated to minimize the consequences of sarcopenia in this population. Read more about this study
- Who is it for?
- Ages 60 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Frail Elderly Syndrome
- What is being tested?
- WBV + IMT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2018to 30 Jul 2019
- 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 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elderly individuals able to walk without assistance
- Good understanding to carry out the proposed tests, evaluated through the Mini Mental State Examination (MMSE).
Who cannot join
- Contraindication or difficulty to perform evaluation procedures
- Users of medications that interfere with the cardiovascular and / or muscular system
- Smokers
- Neuromuscular or degenerative diseases
- Pulmonary comorbidities
- Heart diseases
- Labyrinthitis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Whole Body Vibration Associated With the Inspiratory Muscle Training Program on Inflammatory Markers, Body Composition, Muscle Strength and Thickness
Aging generates immune, muscular and functional changes. In the pre-frail elderly these changes may be increased and, therefore, preventive interventions are indicated to minimize the consequences of sarcopenia in this population. This study aims to evaluate the effects of a whole body vibration training associated with the training of inspiratory muscles on the inflammatory, muscular and body composition outcomes in pre-frail elderly women.
- Conditions
- Frail Elderly Syndrome
- Being tested
- WBV + IMT, WBV + IMTsham, WBVsham + IMTsham
- Keywords
- aging, whole body vibration, respiratory muscle training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WBV + IMTOther
The whole body vibration training will be performed through a vibrating platform with three axes and vibration frequency set at 35 Hz. The amplitude used will be 02 to 04 mm.The inspiratory muscle training will be performed through a device that provides inspiratory resistance.
WBV + IMTshamOther
The whole body vibration training will be performed through a vibrating platform with three axes and vibration frequency set at 35 Hz. The amplitude used will be 02 to 04 mm.The inspiratory muscle training sham will be performed through a device without inspiratory resistance.
WBVsham + IMTshamOther
Whole body vibration training will be performed through a vibrating platform coupled to a device that generates non-therapeutic low frequency vibration. The simulation of inspiratory muscle training will be performed through a device with no inspiratory resistance.
| Study group | Role | What they receive |
|---|---|---|
| WBV + IMT | Experimental | Whole body vibration training associated with respiratory muscle training (WBV + IMT) Receives: Other: WBV + IMT |
| WBV + IMTsham | Active comparator | Whole body vibration training associated with respiratory muscle training sham (WBV + IMTsham) Receives: Other: WBV + IMTsham |
| WBVsham + IMTsham | Sham comparator | Whole body vibration training sham associated with respiratory muscle training sham (WBVsham + IMTsham) Receives: Other: WBVsham + IMTsham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Muscle Strength and Resistance
Maximum Inspiratory and Expiratory Pressure will be evaluated through manovacuometer
Measured: Change from Baseline respiratory muscle strength and resistance at 3 months
Secondary outcomes (5)
Thickness of the quadriceps muscle
Ultrasound will be used to assess the thickness of the quadriceps muscle according to the pre-established protocol.
Measured: Change from Baseline thickness of the quadriceps muscle at 3 months
Diaphragmatic thickness
Ultrasound will to use to evaluate diaphragm thickness non-invasively in the zone of apposition during tidal breathing and with changes in lung volume.
Measured: Change from Baseline diaphragmatic thickness at 3 months
Diaphragmatic mobility
During respiration to total lung capacity, measurement of the diaphragmatic excursion will be assessed by ultrasonography.
Measured: Change from Baseline diaphragmatic mobility at 3 months
Body Composition
Body composition will be evaluated through bioimpedance balance
Measured: Change from Baseline body composition at 3 months
Inflammatory markers
Blood concentration of Interleukin 6 (IL-6), tumor necrosis factor alpha (TNF-alpha) and brain-derived neurotrophic factor (BDNF) will be assessed through blood plasma sample.
Measured: Change from Baseline inflammatory markers at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start1 Oct 2018
- Primary completion30 May 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail Elderly SyndromeStudies 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
- Participant, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helga Cecília Muniz de Souza, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03689322
- Sponsor's protocol ID
- WBV on inflammatory biomarkers
- Status last verified
- Sep 2019
- First submitted
- 25 Sep 2018
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Whole Body Vibration Associated With the Inspiratory Muscle Training Program on Inflammatory Markers, Body Composition, Muscle Strength and Thickness
- ClinicalTrials.gov ID
- NCT03689322
- Acronym / sponsor ID
- WBV on inflammatory biomarkers
- Conditions
- Frail Elderly Syndrome
- Keywords
- aging, whole body vibration, respiratory muscle training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 28 Sep 2018 (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.
Aging generates immune, muscular and functional changes. In the pre-frail elderly these changes may be increased and, therefore, preventive interventions are indicated to minimize the consequences of sarcopenia in this population. This study aims to evaluate the effects of a whole body vibration training associated with the training of inspiratory muscles on the inflammatory, muscular and body composition outcomes in pre-frail elderly women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| WBV + IMT | Experimental | Other: WBV + IMTWhole body vibration training associated with respiratory muscle training (WBV + IMT) |
| WBV + IMTsham | Active comparator | Other: WBV + IMTshamWhole body vibration training associated with respiratory muscle training sham (WBV + IMTsham) |
| WBVsham + IMTsham | Sham comparator | Other: WBVsham + IMTshamWhole body vibration training sham associated with respiratory muscle training sham (WBVsham + IMTsham) |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elderly individuals able to walk without assistance
- Good understanding to carry out the proposed tests, evaluated through the Mini Mental State Examination (MMSE).
Key exclusion criteria (7 listed)
- Contraindication or difficulty to perform evaluation procedures
- Users of medications that interfere with the cardiovascular and / or muscular system
- Smokers
- Neuromuscular or degenerative diseases
- Pulmonary comorbidities
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 |
|---|---|---|
| WBV + IMTThe whole body vibration training will be performed through a vibrating platform with three axes and vibration frequency set at 35 Hz. The amplitude used will be 02 to 04 mm.The inspiratory muscle training will be performed through a device that provides inspiratory resistance. | Other | WBV + IMT |
| WBV + IMTshamThe whole body vibration training will be performed through a vibrating platform with three axes and vibration frequency set at 35 Hz. The amplitude used will be 02 to 04 mm.The inspiratory muscle training sham will be performed through a device without inspiratory resistance. | Other | WBV + IMTsham |
| WBVsham + IMTshamWhole body vibration training will be performed through a vibrating platform coupled to a device that generates non-therapeutic low frequency vibration. The simulation of inspiratory muscle training will be performed through a device with no inspiratory resistance. | Other | WBVsham + IMTsham |
Primary outcome
Respiratory Muscle Strength and Resistance
Time frame: Change from Baseline respiratory muscle strength and resistance at 3 months
Maximum Inspiratory and Expiratory Pressure will be evaluated through manovacuometer
5 secondary outcomes
Thickness of the quadriceps muscle
Time frame: Change from Baseline thickness of the quadriceps muscle at 3 months
Diaphragmatic thickness
Time frame: Change from Baseline diaphragmatic thickness at 3 months
Diaphragmatic mobility
Time frame: Change from Baseline diaphragmatic mobility at 3 months
Body Composition
Time frame: Change from Baseline body composition at 3 months
Inflammatory markers
Time frame: Change from Baseline inflammatory markers at 3 months
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 25 Sep 2019.
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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?
A study testing WBV + IMT in people with Frail Elderly Syndrome, 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 2 inclusion and 7 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 25 Sep 2019. 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. Some participants in this study may receive a placebo. 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?
Respiratory Muscle Strength and Resistance (time frame: Change from Baseline respiratory muscle strength and resistance at 3 months). 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 25 Sep 2019.