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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03448276
Other study ID # Vibration, Walk And Osteop
Secondary ID CAAE N. 80679117
Status Completed
Phase N/A
First received
Last updated
Start date February 26, 2018
Est. completion date August 8, 2019

Study information

Verified date October 2019
Source Universidade Federal de Pernambuco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date August 8, 2019
Est. primary completion date January 9, 2019
Accepts healthy volunteers No
Gender All
Age group 60 Years to 90 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Brazil UFPE Recife Pernambuco

Sponsors (1)

Lead Sponsor Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Muscular strength Test of 1 repetition maximum (1RM) 20 minutes
Primary Balance Berg Balance scale (BBS). Minimum score 0 and maximum 56, the lower the score the greater the risk of falls. 20 minutes
Primary Functional performance Timed Up and Go test (TUG) 20 minutes
Primary Balance Stabilometry by Baropodometry 20 minutes
Secondary Plantar pressure distribution Baropodometry 20 minutes
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