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

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ClinicalTrials.gov Identifier: NCT03448276
Recruitment Status : Not yet recruiting
First Posted : February 28, 2018
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Maria das Graças Rodrigues de Araújo, Universidade Federal de Pernambuco

Brief 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.


Condition or disease Intervention/treatment Phase
Osteoporosis Other: Training in the vibrating platform Other: Walk Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two 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.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Triple: a researcher shall be exclusively responsible for the evaluations and reevaluations not having knowledge of what intervention group the patient will enter. The patient will be allocated among three groups. After the final evaluations, all data will be analyzed by another researcher directed solely to that purpose. Therefore, there will be a triple blinding (researcher, patient and statistician).
Primary Purpose: Treatment
Official Title: Immediate Effect Of Whole-Body Vibration And Walk Over Muscle Strength, Balance And Functional Performance In Elderly People With Osteoporosis And Osteopenia: Clinical Randomized Controlled Trial
Estimated Study Start Date : February 26, 2018
Estimated Primary Completion Date : April 9, 2018
Estimated Study Completion Date : June 4, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Arm Intervention/treatment
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
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.

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
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.




Primary Outcome Measures :
  1. Muscular strength [ Time Frame: 20 minutes ]
    Test of 1 repetition maximum (1RM)

  2. Balance [ Time Frame: 20 minutes ]
    Berg Balance scale (BBS). Minimum score 0 and maximum 56, the lower the score the greater the risk of falls.

  3. Functional performance [ Time Frame: 20 minutes ]
    Timed Up and Go test (TUG)

  4. Balance [ Time Frame: 20 minutes ]
    Stabilometry by Baropodometry


Secondary Outcome Measures :
  1. Plantar pressure distribution [ Time Frame: 20 minutes ]
    Baropodometry



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

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


Responsible Party: Maria das Graças Rodrigues de Araújo, Professor, PhD, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT03448276     History of Changes
Other Study ID Numbers: Vibration, Walk And Osteop
CAAE N. 80679117.5.0000.5208 ( Other Identifier: UFPE )
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Maria das Graças Rodrigues de Araújo, Universidade Federal de Pernambuco:
Osteoporosis
Muscle Strength
Postural Balance
Vibration
Walking

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases