Clinical trial NCT03910348: Effects of Whole-Body Vibration and High Impact Exercises in Postmenopausal Women
Official title: Effects of Whole-Body Vibration and High Impact Exercises on the Bone Metabolism and Fall Risk in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis, Postmenopausal
Exercise Therapy
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2019-04-10
Enrollment: 58
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We investigated the effects of whole body vibration (WBV) and high-impact (HI) exercises in postmenopausal women with low bone mineral density. In summary, WBV exercises are effective in preventing bone loss and WBV and HI exercise programs are effective in decreasing fall risk, increasing health-related quality of life and improving depressive symptoms

Detailed description: Purpose: The aim of this study was to determine the effects of six months of supervised whole-body vibration (WBV) and high-impact (HI) exercises on bone mineral density (BMD), serum bone turnover markers, fall risk, health-related quality of life (HRQoL) and depressive symptoms in postmenopausal women, additionally, to evaluate the advantage of each training program to another.

Methods: In a prospective, randomized controlled 6-month interventional trial 58 eligible postmenopausal women were assigned to WBV training group (n=19), HI training group (n=19), or control group (n=20). The patients in both training groups participated in a supervised training program, which consisted of the one-hour exercise session three times a week for six months. The WBV groups received vibration (30-35 Hz, 2-4 mm) in five different static positions. The HI group jumped rope (10-50 jumps/day). All patients received calcium (1000 mg) and vitamin D (880 IU) supplementation per day. In all participants, baseline and six-month BMD at the lumbar spine and femur were measured by Dual-energy X-ray Absorptiometry (DXA). Serum osteocalcin (OC) and C-terminal telopeptide of type I collagen (CTx) were measured at baseline, three- and six-month intervals. Fall risk was assessed by using the Timed Up and Go (TUG) test and fall index measured by static posturography at baseline, three- and six-month intervals. HRQoL and depressive symptoms were assessed using the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) and Beck Depression Inventory (BDI), respectively, at baseline and six-month of the study.

Eligibility criteria: Inclusion Criteria:

* Postmenopausal women aged 40-65 years old
* Bone mineral density T-scores between -2.0 and -3.0 at the L1-L4, L2-L4, femoral neck, trochanter and/or total hip regions
* Serum 25(OH)vitamin D level ≥ 30 ng/ml.

Exclusion Criteria:

* The use of any medications and/or disease that affect bone metabolism
* Neuromuscular performance, and/or balance; presence of cardiovascular, pulmonary, neuromuscular, and/or chronic diseases that affect exercise training
* Presence of an osteoporotic fracture
* Presence of a musculoskeletal disease, such as an acute lumbar herniated disc and/or spondylolisthesis
* Presence of gall or kidney stones, prostheses, intraocular lenses, and/or implants
* Body mass index ≥35 kg/m²
* Thrombosis history

Primary outcomes:
measure: Change from Baseline Bone Mineral Density at 6 months
timeFrame: baseline and 6 month
Secondary outcomes:
measure: Change from Baseline Bone Formation Marker at 3-months and 6-months
timeFrame: baseline, 3-month, 6-month
measure: Change from Baseline Bone Resorption Marker- at 3-months and 6-months
timeFrame: baseline, 3-month, 6-month
measure: Change from Baseline Fall risk at 3-months and 6-months
timeFrame: baseline, 3-month, 6-month
measure: Change from Baseline Functional Balance at 3-months and 6-months
timeFrame: baseline, 3-month, 6-month
measure: Change from Baseline Health-related Quality of Life at 6 months
timeFrame: baseline, 6-month
measure: Change from Baseline Depressive Symptoms at 6 months
timeFrame: baseline, 3-month, 6-month
Other outcomes:
Locations:
Study officials:
affiliation: Istanbul University
name: Ekin I Sen
role: PRINCIPAL_INVESTIGATOR
References: