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

NCT03448276 | Completed

• 2 other identifiers: Vibration, Walk And OsteopCAAE N. 80679117.5.0000.5208
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis

Keywords

Osteoporosis; Muscle Strength; Postural Balance; Vibration; Walking

Outcome Measures

Primary Outcomes (4)

• Muscular strength

  Test of 1 repetition maximum (1RM)

  20 minutes

• Balance

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

  20 minutes

• Functional performance

  Timed Up and Go test (TUG)

  20 minutes

• Balance

  Stabilometry by Baropodometry

  20 minutes

Secondary Outcomes (1)

• Plantar pressure distribution

  20 minutes

Study Arms (2)

Training in the vibrating platform

EXPERIMENTAL

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

Walk

ACTIVE COMPARATOR

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

Training in the vibrating platform OTHER

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.

Training in the vibrating platform

Walk OTHER

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.

Walk

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (1)

UFPE

Recife, Pernambuco, Brazil

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Walking

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PhD

Model Details: 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.

Study Record Dates

• First Submitted: February 2, 2018
• First Posted: February 28, 2018
• Study Start: February 26, 2018
• Primary Completion: January 9, 2019
• Study Completion: August 8, 2019
• Last Updated: October 22, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)