Skip to main content
OpenTrials
Completed

NCT Number: NCT04353700

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

30 year–48 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Massachusetts

Lowell, Massachusetts, 01854, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Yoga group

Behavioral

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.

Primary outcomes

  1. Change in Physical activity participation was assessed.

    Time frame: BPAQ scores were collected at baseline, at 6 weeks, and after 12 weeks to see any differences throughout the intervention periods.

    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).

  2. Change in Health history was assessed.

    Time frame: HH questionnaires were collected at baseline, at 6 weeks, and after 12 weeks to see any changes throughout the intervention periods.

    A health history questionnaire (HH) was utilized to examine any medical history that can affect bone and cardiovascular health.

  3. Change in menstrual history was assessed

    Time frame: MH questionnaires were collected at baseline, at 6 weeks, and after 12 weeks to see any changes throughout the intervention periods.

    A menstrual history questionnaire (MH) was used to determine if a participant was pregnant.

  4. Change in calcium intake was assessed

    Time frame: CI questionnaires were collected at baseline, at 6 weeks, and after 12 weeks to see any changes throughout the intervention periods.

    Daily calcium intake (mg/d) was estimated using a calcium intake questionnaire (CI).

  5. Change in Body Mass Index (BMI) was assessed

    Time frame: Height and weight were collected at baseline and after 12 weeks.

    Height (cm) and weight (kg) were collected to calculate BMI (kg/m2).

  6. Change in total fat mass was assessed

    Time frame: Total fat mass was measured at baseline and after 12 weeks.

    Total fat mass (g) was measured using Dual Energy-X-ray Absorptiometry.

  7. Change in bone free lean body mass was assessed

    Time frame: Bone free lean body mass was measured at baseline and after 12 weeks.

    Bone free lean body mass (g) was measured using Dual Energy-X-ray Absorptiometry.

  8. Change in %fat was assessed

    Time frame: %fat was measured at baseline and after 12 weeks.

    %fat (%) was measured using Dual Energy-X-ray Absorptiometry.

  9. Change in P1NP was assessed.

    Time frame: Blood draws were collected at baseline, at 6 weeks, and after 12 weeks.

    A blood draw (approximately 10 ml) was collected to investigate differences in bone formation marker (P1NP, ng/mL)

  10. Change in CTX was assessed

    Time frame: Blood draws were collected at baseline, at 6 weeks, and after 12 weeks.

    A blood draw (approximately 10 ml) was collected to investigate differences in bone resorption marker (CTX, ng/mL)

Secondary outcomes

  1. Change in Arterial stiffness was assessed

    Time frame: Arterial stiffness was collected at baseline, at 6 weeks, and after 12 weeks

    Arterial stiffness (m/s) was measured using Pulse Wave Velocity (PWV) to look at intervention effects.

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Lowell

Other

Registry information

Official study title

Does a 12-week Home-based Dynamic Yoga Intervention Improve Bone and Cardiovascular Health in Healthy Premenopausal Women? A Randomized Controlled Feasibility Study

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 20, 2020
Registry last updated
Apr 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.