NCT01681719

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 10, 2012

Completed
Last Updated

September 10, 2012

Status Verified

September 1, 2012

Enrollment Period

11 months

First QC Date

August 30, 2012

Last Update Submit

September 5, 2012

Conditions

Keywords

VO2VCO2VE/VO2heart rate

Outcome Measures

Primary Outcomes (1)

  • maximal O2 consumption

    started and finished the protocol after 03 months

Study Arms (3)

WBV and resistance

EXPERIMENTAL

used both interventions

Device: WBV and Resistance

WBV & resistance sham

EXPERIMENTAL

used the vibrating platform and sham for resistance training

Device: WBV & resistance sham

Resistance & sham WBV

EXPERIMENTAL

used resistance exercises and sham for vibrating platform

Device: resistance & sham WBV

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.

WBV and resistance

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.

Resistance & sham WBV

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.

WBV & resistance sham

Eligibility Criteria

Age60 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UFPE

Recife, Pernambuco, 50740-560, Brazil

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 30, 2012

First Posted

September 10, 2012

Study Start

January 1, 2011

Primary Completion

December 1, 2011

Last Updated

September 10, 2012

Record last verified: 2012-09

Locations