Effects of a 12-week Home-based Yoga on Bone and Cardiovascular Health

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04353700
• Other study ID #: 17-183-KIM-XPD
• Status: Completed
• Phase: N/A
• Start date: September 19, 2018
• Est. completion date: September 25, 2019

Study information

• Verified date: April 2020
• Source: University of Massachusetts, Lowell
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Osteoporosis

Intervention

Behavioral:
• Yoga group
During the in-home yoga intervention, participants performed 30 to 50 minutes of yoga postures three to five times a week for 12 weeks, including 5 minutes of warm-up exercise, 15 to 30 minutes of dynamic flow yoga postures, 10 minutes of weight barring standing postures, and 5 minutes of cool-down. These in-home sessions were a repeat of what participants learned during the first week of training session at UML. We progressively increased the intensity of the home practice sessions by adding the number of sun salutation (SS) over the 12 weeks.

Locations

Country	Name	City	State
United States	University of Massachusetts	Lowell	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Lowell

Country where clinical trial is conducted

United States, 

Outcome

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