NCT03918291

Brief Summary

The present study evaluated the effects of adding whole body vibration to squat training on the isometric quadriceps muscle strength, the plasma concentration of brain-derived neurotrophic factor at rest in elderly woman with osteoarthritis of the knee. The eligible patients were fifteen elderly women ≥ 60 years of age who had been diagnosed with osteoarthritis of the knee. The intervention consisted of uninterrupted squatting exercises for 12 weeks, a 3x/week. The exercise protocol was similar in both groups differed only in the presence of vibration.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2008

Longer than P75 for not_applicable

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

October 28, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2010

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2012

Completed
6.8 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 17, 2019

Completed
Last Updated

April 26, 2019

Status Verified

April 1, 2019

Enrollment Period

2 years

First QC Date

April 10, 2019

Last Update Submit

April 24, 2019

Conditions

Keywords

Muscle strengthSquatBrain derived neurotrophic factorOsteoarthritis of kneeWhole-body vibrationElderly

Outcome Measures

Primary Outcomes (1)

  • Change in isometric quadriceps muscle strength

    The maximal voluntary isometric contraction of knee extensors measured using the load cell

    24 hours before and 24 hours after a 12-week training program

Secondary Outcomes (1)

  • Change in plasma concentration of neurotrophin 40/5000 Plasma neurotrophin concentration

    24 hours before and 24 hours after a 12-week training program

Study Arms (2)

Addition of whole-body vibration to squat training

EXPERIMENTAL

The addition of whole-body vibration to squat training (for 12 weeks, 3x/week). The mechanical stimulation parameters of the vibration consisted of the following: frequency of 35 to 40 Hz, amplitude of 4 mm and acceleration that ranged from 2.78 to 3.26 G

Other: Addition of whole-body vibration to squat training

Squat training

OTHER

Squatting exercises for 12 weeks, 3x/week

Other: Squat training

Interventions

Addition of whole-body vibration to squat training

squatting exercises for 12 weeks, 3x/week

Squat training

Eligibility Criteria

Age65 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • females older than 65 years of age
  • not using hormone replacement therapy
  • diagnosed with OA in at least one knee in accordance with of the American College of Rheumatology

You may not qualify if:

  • no recent knee injury
  • no walking aid requirement
  • no rehabilitation procedures in the previous three months
  • any orthopedic, neurological, respiratory or acute cardiac diseases
  • any cognitive deficit as determined by the Mini-Mental State Examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Simao AP, Mendonca VA, Avelar NCP, da Fonseca SF, Santos JM, de Oliveira ACC, Tossige-Gomes R, Ribeiro VGC, Neves CDC, Balthazar CH, Leite HR, Figueiredo PHS, Bernardo-Filho M, Lacerda ACR. Whole Body Vibration Training on Muscle Strength and Brain-Derived Neurotrophic Factor Levels in Elderly Woman With Knee Osteoarthritis: A Randomized Clinical Trial Study. Front Physiol. 2019 Jun 25;10:756. doi: 10.3389/fphys.2019.00756. eCollection 2019.

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Ana Cristina R Lacerda, PhD

    Federal University of the Valleys of Jequitinhonha and Mucuri

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The tests were performed by an experienced examiner who was blind to the group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, controlled trial in which the variables were assessed 24 h before and 24 h after a 12-week training program. For the allocation of participants, a 1:1 ratio randomization was performed.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2019

First Posted

April 17, 2019

Study Start

October 28, 2008

Primary Completion

October 28, 2010

Study Completion

June 28, 2012

Last Updated

April 26, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share