NCT02769143

Brief Summary

Women in the postmenopausal period suffer hormonal changes that contribute to a number of negative factors to health, such as reduced bone mineral density and loss of muscle mass, which contribute to the increased incidence of falls and consequent risk of fractures. Among the possibilities to alleviate these symptoms are mainly drug treatment and the systematic practice of physical exercise. Exercise stands out for not offering adverse effects. One form of exercise that has been recently investigated is the whole body vibration, another form of exercise well accepted by the population is the Pilates method. Taking into account the lack of literature on the benefits of vibration training; and also the Pilates method on bone mineral density, muscle strength, flexibility, postural balance, fear of falling and the quality of life of postmenopausal women, explains the importance of this work.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2016

Shorter than 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

May 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 11, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

November 6, 2017

Status Verified

November 1, 2017

Enrollment Period

6 months

First QC Date

May 7, 2016

Last Update Submit

November 1, 2017

Conditions

Keywords

PostmenopausalBone DensityExercise

Outcome Measures

Primary Outcomes (1)

  • Bone mineral density

    To analyze the bone mass of the femoral neck and lumbar spine (L1-L4) will use the device-ray Absorptiometry Dual Energy X (DXA) HOLOGIC, DQR-1000 PLUS model. The technique is based on the attenuation by the patient's body, a radiation beam generated by an X-ray source with two power levels, and exposure to radiation is lower than that of a conventional X-ray examination. The technique allows to estimate bone mass in whole and body segment. The results are transmitted to the computer that is connected to the device. Bone mineral density (BMD) is expressed as absolute values (g / cm2 grams of bone mineral content per area or analyzed bone cm2).

    six months

Secondary Outcomes (6)

  • Muscle strength

    six months

  • Flexibility

    six months

  • Postural balance

    six months

  • The Timed Up and Go test (TUG)

    six months

  • Fear Falls

    six months

  • +1 more secondary outcomes

Study Arms (3)

Whole-Body Vibration Group (WBV)

EXPERIMENTAL

Will be exposed to five minutes on a vibrating platform (Oscillating Platform Semi-Professional Horizontal - Arktus, Cascavel, Brazil), this type of platform vibrates through an anteroposterior axis, causing the right and left sides alternate horizontally denominated: alternating side vibration platforms, will be performed three times per week on alternate days (5 minutes). a frequency of 20 Hz (1 = 1 Hz oscillation / second) and a magnitude of 3.2 g (1 g = 9,81 m / s gravity) is used. The volunteers will be guided to stand on the platform with semi-flexed knees, barefoot and apart about hip width.

Other: Whole-Body Vibration

Pilates Group (PG)

EXPERIMENTAL

Will be exposed to 60 minutes, held three times a week on alternate days. Pilates equipment used for the exercises are: Combo Chair, Cadillac Trapeze, Ladder Barrel, Reformer Universal, Step Barrel and Wall Unit. Will be selected for this study, 21 strengthening exercises and stretching to the main body segments. All exercises are performed in a series of ten repetitions with one minute interval between exercises. To determine the level of effort and consequently to changing loads, will be used verbal command according to the Borg CR10 scale. The level of effort will be maintained during the session heavy (Borg between 5 and 6).

Other: Pilates

Control Group (CG)

NO INTERVENTION

The control group will be instructed to maintain their usual activities both in relation to their daily activities, dietary habits, failure to use drugs that can influence the increase in bone mass and participate in monthly meetings to address on issues osteoporosis and postmenopausal women. After the end of the interventions with WBV and GP groups, GC volunteers will be invited to also perform whole body vibration for six months. Exposure of vibration will be for five minutes on a vibrating platform, three times per week on alternate days. a frequency of 20 Hz (1 = 1 Hz oscillation / second) and a magnitude of 3.2 g (1 g = 9,81 m / s gravity) is used. Likewise which was offered for the WBV group.

Interventions

Will be performed six months of WBV exercises

Also known as: Whole-Body Vibration Exercise
Whole-Body Vibration Group (WBV)
PilatesOTHER

Will be performed six months of Pilates exercises

Also known as: Pilates Exercise
Pilates Group (PG)

Eligibility Criteria

Age40 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical confirmation of postmenopausal for at least 12 months
  • Not exercise practitioner for at least six months
  • Agreement not to do another type of exercise during the search
  • Ability to perform activities of daily living without assistance
  • Medical certificate stating fitness to practice physical exercise; cognitive state ≥19 according to the Mini-Mental State Examination (MMSE)

You may not qualify if:

  • Musculoskeletal disorders in the spine or the lower limbs in the last six months; fracture in the spine or lower limbs after 40 years of age
  • Prosthesis in the lower limbs or implants in the spine; Secondary causes of loss of bone mass
  • Other metabolic bone diseases or diseases affecting bone metabolism; history of cancer in the last five years; vascular changes
  • Epilepsy or seizures; arrhythmia; Pacemaker use; eye disease affecting the retina
  • Cardiorespiratory diseases; diseases in the neuromuscular system; labyrinthitis or lightheadedness
  • Hospitalization in the last six months for surgical reasons; alteration of Thyroid, drinking alcohol
  • Smoking
  • Use of supplements such as calcium or vitamin D, or containing isoflavones
  • Medication to increase bone mineral density or increased muscle mass in the last 12 months
  • Inability to tolerate 5-minute whole body vibration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Norte do Paraná

Londrina, Paraná, 86041-140, Brazil

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Study Officials

  • Deise A de Almeida Pires-Oliveira, Doctor

    Universidade Norte do Paraná

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctoral student in Sciences Program Rehabilitation

Study Record Dates

First Submitted

May 7, 2016

First Posted

May 11, 2016

Study Start

May 1, 2016

Primary Completion

November 1, 2016

Study Completion

December 1, 2016

Last Updated

November 6, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations