Immediate Effect Of Whole-Body Vibration And Walk in Osteoporosis/Osteopenia
Primary Purpose
Osteoporosis
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Training in the vibrating platform
Walk
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis focused on measuring Osteoporosis, Muscle Strength, Postural Balance, Vibration, Walking
Eligibility 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.
Sites / Locations
- UFPE
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Training in the vibrating platform
Walk
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Muscular strength
Test of 1 repetition maximum (1RM)
Balance
Berg Balance scale (BBS). Minimum score 0 and maximum 56, the lower the score the greater the risk of falls.
Functional performance
Timed Up and Go test (TUG)
Balance
Stabilometry by Baropodometry
Secondary Outcome Measures
Plantar pressure distribution
Baropodometry
Full Information
NCT ID
NCT03448276
First Posted
February 2, 2018
Last Updated
October 18, 2019
Sponsor
Universidade Federal de Pernambuco
1. Study Identification
Unique Protocol Identification Number
NCT03448276
Brief Title
Immediate Effect Of Whole-Body Vibration And Walk in Osteoporosis/Osteopenia
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
February 26, 2018 (Actual)
Primary Completion Date
January 9, 2019 (Actual)
Study Completion Date
August 8, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Pernambuco
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Osteoporosis, Muscle Strength, Postural Balance, Vibration, Walking
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigator
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).
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Training in the vibrating platform
Arm Type
Experimental
Arm Description
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.
Arm Title
Walk
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Training in the vibrating platform
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Walk
Intervention Description
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 Measure Information:
Title
Muscular strength
Description
Test of 1 repetition maximum (1RM)
Time Frame
20 minutes
Title
Balance
Description
Berg Balance scale (BBS). Minimum score 0 and maximum 56, the lower the score the greater the risk of falls.
Time Frame
20 minutes
Title
Functional performance
Description
Timed Up and Go test (TUG)
Time Frame
20 minutes
Title
Balance
Description
Stabilometry by Baropodometry
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
Plantar pressure distribution
Description
Baropodometry
Time Frame
20 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
UFPE
City
Recife
State/Province
Pernambuco
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
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Immediate Effect Of Whole-Body Vibration And Walk in Osteoporosis/Osteopenia
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