- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01681719
Ergospirometric Values and WBV in Elderly (EVAWIE)
Whole Body Vibration as Alternative for Improve the Ergospirometric Values in Elderly: a Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pernambuco
-
Recife, Pernambuco, Brazil, 50740-560
- UFPE
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- aged 60-74 years,
- Sedentary or Moderate A in accord with IPAQ short form (International Physical Activity Questionnaire) and those without disease.
- furthermore, the subjects should reach the ventilatory threshold 1, considered after meeting two of the following events:
- respiratory quotient (R) increases (R ≥1,1);
- loss of linearity between the pulmonary ventilation curve (VE) and oxygen consumption (VO2), plateau of VO2 or plateau of heart rate (HR) and increases of end-tidal PO2 (Pet O2)
Exclusion Criteria:
- Were excluded subjects with changes in Mini-mental state examination (MMSE) scores by age and educational level where the minimum score represents: illiterate 13 points, less than 8 study years is 18 points, 8 or more study years is 26 points 11.
- Were also excluded current smokers or previous, subjects with thrombosis, labyrinthitis, diabetes, hemodynamic instabilities, obesity, osteoporosis, neuromuscular diseases, pulmonary or cardiac diseases, changes in resting electrocardiogram or in exercise, ingestion of drugs to metabolism bone / muscle / heart chronotropism or with difficulties in adapting protocols
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: WBV and resistance
used both interventions
|
use of WBV and resistance device during 03 months in elderly health people. The WBV used progressive increases of time and amplitude and the resistance training improves the weight. For Resistance: performed in upper and lower limbs in weight machine Mega II Movement®, used guidelines from American College of Sports Medicine for elderly, with two series of 08 repetitions (75% weight of one RM), considered for RM calculation the maximum voluntary isometric contraction. For WBV: used MY3 platform (Power Plate®, MY3, UK) frequency 35 hertz, tri-axial, amplitude 02 mm in adaptation and initial phases, increasing to 04 mm in phases intermediate and final. The time initial was 10 minutes, progressed to 15 min in second month, concluding with 20 min. Rest time between series remained 01 min. |
Experimental: WBV & resistance sham
used the vibrating platform and sham for resistance training
|
used really the WBV, but sham for resistance training For Resistance: performed similar movments in upper and lower limbs in weight machine Mega II Movement®, without using weights. For WBV: used MY3 platform (Power Plate®, MY3, UK) frequency 35 hertz, tri-axial, amplitude 02 mm in adaptation and initial phases, increasing to 04 mm in phases intermediate and final. The time initial was 10 minutes, progressed to 15 min in second month, concluding with 20 min. Rest time between series remained 01 min. |
Experimental: Resistance & sham WBV
used resistance exercises and sham for vibrating platform
|
used only resistance For Resistance: performed in upper and lower limbs in weight machine Mega II Movement®, used guidelines from American College of Sports Medicine for elderly, with two series of 08 repetitions (75% weight of one RM), considered for RM calculation the maximum voluntary isometric contraction. For WBV: used MY3 platform (Power Plate®, MY3, UK)off. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
maximal O2 consumption
Time Frame: started and finished the protocol after 03 months
|
started and finished the protocol after 03 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ERGOFORCE1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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