Clinical trial NCT04353700: Effects of a 12-week Home-based Yoga on Bone and Cardiovascular Health
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Cardiovascular Risk Factor
Keywords: Yoga
Bone markers
Arterial stiffness
Premenopausal women
Lead sponsor: University of Massachusetts, Lowell
Sponsor class: OTHER
First posted: 2020-04-20
Enrollment: 35
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were randomly assigned either a yoga intervention group or a control group.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: Presently, it is not clear whether the intensity of Yoga interventions is high enough to induce positive effects on bone and cardiovascular health in a healthy population. For example, Hagins et al. (2007) reported that the metabolic costs of Hatha Yoga, averaged across the entire session, represent low levels of physical activity (walking). On the other hand, Ashtanga Yoga, or power Yoga, is performed at a higher intensity than Hatha Yoga and has been shown to elicit significantly higher heart rates than either Hatha or gentle Yoga (Cowen and Adams, 2007). Sun Salutations (SS) are an example of an Ashtanga Yoga sequence, where yoga postures are performed dynamically with combinations of forward and backward bending poses (Omkar et al., 2011). A previous 8-month yoga intervention found that regular long-term Ashtanga yoga had a small positive effect on bone formation in premenopausal women. Although Yoga has the potential to be an alternative physical activity to improve bone health and arterial stiffness, there is a lack of high-quality evidence for this type of intervention. Thus, the purpose of this study is to assess the feasibility of a 12-week home-based dynamic yoga intervention designed to improve bone metabolism and arterial stiffness in healthy premenopausal women.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Physical activity participation was assessed.
timeFrame: BPAQ scores were collected at baseline, at 6 weeks, and after 12 weeks to see any differences throughout the intervention periods.
measure: Change in Health history was assessed.
timeFrame: HH questionnaires were collected at baseline, at 6 weeks, and after 12 weeks to see any changes throughout the intervention periods.
measure: Change in menstrual history was assessed
timeFrame: MH questionnaires were collected at baseline, at 6 weeks, and after 12 weeks to see any changes throughout the intervention periods.
measure: Change in calcium intake was assessed
timeFrame: CI questionnaires were collected at baseline, at 6 weeks, and after 12 weeks to see any changes throughout the intervention periods.
measure: Change in Body Mass Index (BMI) was assessed
timeFrame: Height and weight were collected at baseline and after 12 weeks.
measure: Change in total fat mass was assessed
timeFrame: Total fat mass was measured at baseline and after 12 weeks.
measure: Change in bone free lean body mass was assessed
timeFrame: Bone free lean body mass was measured at baseline and after 12 weeks.
measure: Change in %fat was assessed
timeFrame: %fat was measured at baseline and after 12 weeks.
measure: Change in P1NP was assessed.
timeFrame: Blood draws were collected at baseline, at 6 weeks, and after 12 weeks.
measure: Change in CTX was assessed
timeFrame: Blood draws were collected at baseline, at 6 weeks, and after 12 weeks.
Secondary outcomes:
measure: Change in Arterial stiffness was assessed
timeFrame: Arterial stiffness was collected at baseline, at 6 weeks, and after 12 weeks
Other outcomes:
Locations:
city: Lowell
country: United States
facility: University of Massachusetts
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Lowell
name: SoJung Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References: