Osteoporosis Clinical Trial
Official title:
Does a 12-week Home-based Dynamic Yoga Intervention Improve Bone and Cardiovascular Health in Healthy Premenopausal Women? A Randomized Controlled Feasibility Study
Verified date | April 2020 |
Source | University of Massachusetts, Lowell |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
While effects of specific exercise interventions on bone and CVD in postmenopausal women have been demonstrated and evaluated, the effects of randomized controlled exercise interventions, particularly in middle-aged premenopausal women are sparse. Therefore, it is imperative to examine the relation between behavioral interventions and bone and cardiovascular outcomes in premenopausal women as this understudied group is at high risk for the initial stages of bone loss and cardiovascular disease development.
Status | Completed |
Enrollment | 35 |
Est. completion date | September 25, 2019 |
Est. primary completion date | February 16, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 30 Years to 48 Years |
Eligibility |
Inclusion Criteria: - Participants were healthy premenopausal women volunteers between the ages of 30 and 48 years. - Participants were free of chronic back or joint problems, cardiovascular disease, non-smokers, not pregnant, not taking antihypertensive drugs or any medication that affects bone density. - Participants didn't have regularly participated in a weight training program and yoga exercise at least 12 months prior to the study. - Participants were medically stable, ambulatory, and capable of training. Exclusion Criteria: - Individual who were outside of the 30-48 years age range and who exceed the weight limit of the DXA (300 pounds). - Individuals who did not have the regular menstrual cycles. - Pregnancy or the possibility of becoming pregnant during the intervention period - Individuals who were taking medications known to affect bone metabolism such as steroid hormones, calcitonin, or corticosteroids. - Any persons with physical and mental disabilities preventing them from being trained, including orthopedic or arthritic problems, were not allowed to participate. - Individuals whose radiation exposure from medical and/or research tests in the previous year exceeds the recommended regulator limit. |
Country | Name | City | State |
---|---|---|---|
United States | University of Massachusetts | Lowell | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
University of Massachusetts, Lowell |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Physical activity participation was assessed. | Participants were asked to fill out a physical activity questionnaire (BPAQ scores) Physical activity participation was estimated with the bone-specific physical activity questionnaire (BPAQ score). | BPAQ scores were collected at baseline, at 6 weeks, and after 12 weeks to see any differences throughout the intervention periods. | |
Primary | Change in Health history was assessed. | A health history questionnaire (HH) was utilized to examine any medical history that can affect bone and cardiovascular health. | HH questionnaires were collected at baseline, at 6 weeks, and after 12 weeks to see any changes throughout the intervention periods. | |
Primary | Change in menstrual history was assessed | A menstrual history questionnaire (MH) was used to determine if a participant was pregnant. | MH questionnaires were collected at baseline, at 6 weeks, and after 12 weeks to see any changes throughout the intervention periods. | |
Primary | Change in calcium intake was assessed | Daily calcium intake (mg/d) was estimated using a calcium intake questionnaire (CI). | CI questionnaires were collected at baseline, at 6 weeks, and after 12 weeks to see any changes throughout the intervention periods. | |
Primary | Change in Body Mass Index (BMI) was assessed | Height (cm) and weight (kg) were collected to calculate BMI (kg/m2). | Height and weight were collected at baseline and after 12 weeks. | |
Primary | Change in total fat mass was assessed | Total fat mass (g) was measured using Dual Energy-X-ray Absorptiometry. | Total fat mass was measured at baseline and after 12 weeks. | |
Primary | Change in bone free lean body mass was assessed | Bone free lean body mass (g) was measured using Dual Energy-X-ray Absorptiometry. | Bone free lean body mass was measured at baseline and after 12 weeks. | |
Primary | Change in %fat was assessed | %fat (%) was measured using Dual Energy-X-ray Absorptiometry. | %fat was measured at baseline and after 12 weeks. | |
Primary | Change in P1NP was assessed. | A blood draw (approximately 10 ml) was collected to investigate differences in bone formation marker (P1NP, ng/mL) | Blood draws were collected at baseline, at 6 weeks, and after 12 weeks. | |
Primary | Change in CTX was assessed | A blood draw (approximately 10 ml) was collected to investigate differences in bone resorption marker (CTX, ng/mL) | Blood draws were collected at baseline, at 6 weeks, and after 12 weeks. | |
Secondary | Change in Arterial stiffness was assessed | Arterial stiffness (m/s) was measured using Pulse Wave Velocity (PWV) to look at intervention effects. | Arterial stiffness was collected at baseline, at 6 weeks, and after 12 weeks |
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