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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01681719
Other study ID # ERGOFORCE1
Secondary ID
Status Completed
Phase N/A
First received August 30, 2012
Last updated September 5, 2012
Start date January 2011

Study information

Verified date September 2012
Source Universidade Federal de Pernambuco
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial Summary

this study aims evaluate the ergospirometric values after 03 months of training with WBV in elderly health people. The hypothesis is increases of ergospirometric values.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date
Est. primary completion date December 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 60 Years to 74 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Device:
WBV and Resistance
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.
resistance & sham WBV
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.
WBV & resistance sham
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.

Locations

Country Name City State
Brazil UFPE Recife Pernambuco

Sponsors (1)

Lead Sponsor Collaborator
Maíra F Pessoa

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary maximal O2 consumption started and finished the protocol after 03 months No
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