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CompletedNCT03448276Updated Oct 22, 2019

Immediate Effect Of Whole-Body Vibration And Walk in Osteoporosis/Osteopenia

An interventional study of Training in the vibrating platform and Walk in Osteoporosis, sponsored by Universidade Federal de Pernambuco. Completed at 1 site in Brazil. Open to participants aged 60 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-10-22.

Sponsored by Universidade Federal de Pernambuco · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
60 Years to 90 Years
Sex
All
01

Study summary

Introduction: Osteoporosis and Osteopenia are common bone disorders, characterized by low bone mass, signs of bone deterioration and are responsible for typical bone fragility. Physical activity is certainly a valid prevention tool because it contributes to a healthy energy balance, increasing muscle mass and providing beneficial effects in bone metabolism. Stress induced by more vigorous activities such as weight lifting, increases the risk of injury, particularly in the elderly. Therefore, alternative strategies with lower risk of injury are indicated such as whole body vibration and walk.

Objective: Compare the effect whole body vibration and walking on muscular strength, balance and functional performance in the elderly with Osteoporosis and Osteopenia

Methods: It is a clinical trial study, controlled, parallel, randomized and blind, which will follow the guidelines established in the Consolidated Standards of Reporting Trials (CONSORT). Participants will be randomly distributed in 2 groups: the experimental group (GI) that will hold the training in the vibrating platform and the control group (GC) that will perform the walk, settling 1 treatment session. All participants will be subjected to the initial and final assessment.

02

Conditions studied

  • Osteoporosis

Keywords

  • Osteoporosis
  • Muscle Strength
  • Postural Balance
  • Vibration
  • Walking
03

Who can participate

Ages eligible
60 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Confirmed diagnosis of osteoporosis or osteopenia examination of bone densitometry;
  • Patients without severe neurological disease, vascular disorders, labyrinthitis and blindness;
  • No use of gait auxiliaries;
  • No history of fractures of the lower limbs in the last year;
  • Do not be an alcoholic inactive (0 to 5 points) or less active (6 to 11 points) accordance with the usual physical activity questionnaire (QAFH).

Exclusion criteria

Exclusion Criteria:

-Patients who submit to hypertensive peak, nausea and dizziness during the training program.

04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    Training in the vibrating platform

    20-minute workout will be held, which will include: heating (5 minutes and stretching for the muscles quadriceps and sural triceps), 10 and 5 min of cooling.

    Other: Training in the vibrating platform

  • Active comparator
    Walk

    Will be held 30 minutes of training, which will include the heating (5 minutes of stretching for the muscles quadriceps and sural triceps), 10 and 5 min of cooling.

    Other: Walk

Interventions

  • OtherTraining in the vibrating platform

    20-minute workout will be held, which will include: heating (5 minutes and stretching for the muscles quadriceps and sural triceps), 10 and 5 min of cooling.

  • OtherWalk

    Will be held 30 minutes of training, which will include the heating (5 minutes of stretching for the muscles quadriceps and sural triceps), 10 and 5 min of cooling.

05

What researchers measure

Primary outcomes

  1. Muscular strength

    Test of 1 repetition maximum (1RM)

    Time frame: 20 minutes

  2. Balance

    Berg Balance scale (BBS). Minimum score 0 and maximum 56, the lower the score the greater the risk of falls.

    Time frame: 20 minutes

  3. Functional performance

    Timed Up and Go test (TUG)

    Time frame: 20 minutes

  4. Balance

    Stabilometry by Baropodometry

    Time frame: 20 minutes

Secondary outcomes

  1. Plantar pressure distribution

    Baropodometry

    Time frame: 20 minutes

06

Study locations

1 site
  • UFPE
    Recife, Pernambuco, Brazil
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03448276
Lead sponsor
Universidade Federal de Pernambuco
Responsible party
Maria das Graças Rodrigues de Araújo (Professor, PhD, Universidade Federal de Pernambuco) — Principal investigator
First posted
Feb 28, 2018
Start date
Feb 26, 2018
Primary completion
Jan 9, 2019
Completion
Aug 8, 2019
Last update
Oct 22, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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