Quality of Life Clinical Trial
Official title:
Effects of Whole Body Vibration in Different Devices on Bone and Muscle Mass, Physical Performance, Quality of Life and Falls in Postmenopausal Women
Postmenopausal women suffer from a series of negative health factors, such as decreased bone and muscle mass and physical performance, increasing the risk of falls and decreasing quality of life. Therefore, intervention strategies aimed at mitigating these factors are essential. A technique that has been studied and can reverse these factors is whole-body vibration (WBV), however studies present contradictory results and the main confounding factor appears to be related to the type of vibration (synchronous or side-alternating). Therefore, the primary objective of this project is to verify the effects of 12 months of whole-body vibration on different devices on bone mineral density measurements in postmenopausal women. As a secondary objective, the effects on muscle mass, physical performance, quality of life and falls will be verified. 228 postmenopausal women will participate in the study and will be randomized to: triplanar vibration (synchronous); side-alternating vibration; or false vibration. The interventions will last 12 months and will occur three times a week on non-consecutive days. The following assessments will be carried out at baseline, 6-months and 12-months: bone mineral density and muscle mass by DXA equipment, muscle thickness by ultrasound, peak torque of the knee extensor and flexor muscles by an isokinetic dynamometer, hand grip, balance static postural and vertical jump on a force platform, dynamic balance using the Timed Up and Go test, SPPB battery, fear (FES-I) and incidence of falls and quality of life (SF-36).
Status | Recruiting |
Enrollment | 228 |
Est. completion date | June 30, 2025 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 50 Years to 80 Years |
Eligibility | Inclusion Criteria: - Being postmenopausal (without menstruating for at least 12 months); - Not performing physical exercise systematically for at least 6 months; - Not needing assistance to carry out daily tasks; - Do not present serious cognitive problems that make it impossible to understand simple commands; - Do not have serious dysfunctions or implants in the spine, hips or lower limbs; - Not have neurological diseases or diseases that affect bone metabolism; - Do not have vascular diseases, arrhythmia, use a pacemaker, suffer from epilepsy or seizures; - No diseases/problems that affect the retina; - Do not present severe labyrinthitis or vertigo; - Not using medication/supplements to increase bone and/or muscle mass for at least 6 months; - Have not undergone cancer treatment in the last 5 years. Exclusion Criteria: - Withdraw from participating in the study for any reason; - Present adverse events during interventions that cannot be controlled. |
Country | Name | City | State |
---|---|---|---|
Brazil | Universidade Estadual do Norte do Paraná | Jacarezinho | Paraná |
Lead Sponsor | Collaborator |
---|---|
Universidade Estadual do Norte do Parana | Conselho Nacional de Desenvolvimento Científico e Tecnológico |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bone mineral density | Bone mineral density of the lumbar spine, total hip, femoral neck and trochanter assessed by DXA, expressed in g/cm2 | Baseline (pre-intervention), 6-months and 12-months | |
Primary | Appendicular skeletal muscle mass | Appendicular skeletal muscle mass assessed by DXA, expressed in kg/m2 | Baseline (pre-intervention), 6-months and 12-months | |
Secondary | Muscle thickness | Thickness of the rectus femoris muscle assessed by ultrasound, expressed in cm | Baseline (pre-intervention), 6-months and 12-months | |
Secondary | Physical Performance | SPPB functional test battery composed of: static balance (feet together, semi-tandem, and full-tandem); gait speed test (4m); and 5-time sit-to-stand. All expressed in seconds. | Baseline (pre-intervention), 6-months and 12-months | |
Secondary | Dynamic balance | Timed Up and Go test: time taken to get up from a chair, walk three meters, return and sit down in the chair. | Baseline (pre-intervention), 6-months and 12-months | |
Secondary | Hand grip strength | Handgrip test using a Jamar hydraulic dynamometer, expressed in kg. | Baseline (pre-intervention), 6-months and 12-months | |
Secondary | Static postural balance | Bipedal and semi-tandem postural balance test on a force platform to verify the antero-posterior displacement speed (cm/s), medio-lateral displacement speed (cm/s) and COP area (cm2). | Baseline (pre-intervention), 6-months and 12-months | |
Secondary | Muscle power | Countermovement vertical jump with hands on waist to identify the power of the lower limbs expressed in watts. | Baseline (pre-intervention), 6-months and 12-months | |
Secondary | Lower limb muscle strength | Peak isokinetic torque (N.m) of the knee extensor and flexor muscles (concentric/concentric) evaluated by an isokinetic dynamometer at angular velocities of 60, 180 and 300ยบ/s. | Baseline (pre-intervention), 6-months and 12-months | |
Secondary | Fear of falls | Fear of falls assessed by the falls efficacy scale-international (FES-I), which generates scores from 16 to 64 points. | Baseline (pre-intervention), 6-months and 12-months | |
Secondary | Health-related quality of life | The SF-36 questionnaire will be used, which generates scores of 0-100 points for eight domains of health-related quality of life. | Baseline (pre-intervention), 6-months and 12-months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05559255 -
Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI
|
N/A | |
Completed |
NCT06238557 -
Prospective Evaluation of Psychological Consequences and Impact on Long-term Quality of Life
|
||
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Completed |
NCT05472935 -
Asynchronous Mindfulness Based Stress Reduction to Reduce Burnout in Licensed Clinical Social Workers
|
N/A | |
Recruiting |
NCT04444544 -
Quality of Life and High-Risk Abdominal Cancer Surgery
|
||
Completed |
NCT04281953 -
Impact on Quality of Life of Long-term Ototoxicity in Cancer Survivors
|
||
Recruiting |
NCT05546931 -
Mobile Health Program for Rural Hypertension
|
N/A | |
Active, not recruiting |
NCT04746664 -
Effects of Nutrition Counselling on Old Age People's Nutritional Status and Quality of Life in Bahir Dar City, North West Ethiopia
|
N/A | |
Completed |
NCT05387174 -
Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period
|
N/A | |
Recruiting |
NCT04142827 -
The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care in Patients With Bronchiectasis (BX)
|
N/A | |
Active, not recruiting |
NCT05903638 -
A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility
|
N/A | |
Completed |
NCT05538455 -
Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases
|
N/A | |
Completed |
NCT06216015 -
Exercise Training and Kidney Transplantation
|
N/A | |
Completed |
NCT03813420 -
Sleep Quality of Physiotherapy Students Quality of Life and Physical Activity Level
|
N/A | |
Recruiting |
NCT05550545 -
Infant RSV Infections and Health-related Quality of Life of Families
|
||
Completed |
NCT05346588 -
THRIVE Feasibility Trial
|
Phase 3 | |
Recruiting |
NCT05233020 -
Robotic Versus Hybrid Assisted Ventral Hernia Repair
|
N/A | |
Terminated |
NCT03304184 -
The Role of Biodentine in Class V Dental Lesions on Oral Health Related Quality of Life
|
Phase 3 | |
Completed |
NCT05063305 -
Probiotics, Immunity, Stress, and QofL
|
N/A | |
Recruiting |
NCT05380856 -
Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction
|
N/A |