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

April 16, 2020 updated by: SoJung Kim, University of Massachusetts, Lowell

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Lowell, Massachusetts, United States, 01854
        • University of Massachusetts

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

26 years to 44 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Yoga group
A certified yoga instructor led the supervised yoga session. An exercise physiologist taught how to record your Rating of Perceived Exertion to monitor their exercise intensity during the in-home yoga intervention. During the in-home yoga intervention, participants performed 30 to 50 minutes of yoga postures three to five times a week for 12 weeks.
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.
No Intervention: Control group
If participants were in a CON group, they did not receive the yoga intervention. Instead, they were encouraged to maintain a normal daily lifestyle monitored by the BPAQ at one-month intervals during the 12-week intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
BPAQ scores were collected at baseline, at 6 weeks, and after 12 weeks to see any differences throughout the intervention periods.
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.
HH questionnaires were collected at baseline, at 6 weeks, and after 12 weeks to see any changes throughout the intervention periods.
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.
MH questionnaires were collected at baseline, at 6 weeks, and after 12 weeks to see any changes throughout the intervention periods.
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).
CI questionnaires were collected at baseline, at 6 weeks, and after 12 weeks to see any changes throughout the intervention periods.
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).
Height and weight were collected at baseline and after 12 weeks.
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.
Total fat mass was measured at baseline and after 12 weeks.
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.
Bone free lean body mass was measured at baseline and after 12 weeks.
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.
%fat was measured at baseline and after 12 weeks.
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)
Blood draws were collected at baseline, at 6 weeks, and after 12 weeks.
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)
Blood draws were collected at baseline, at 6 weeks, and after 12 weeks.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Arterial stiffness was collected at baseline, at 6 weeks, and after 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Massachusetts, Lowell

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: SoJung Kim, PhD, University of Massachusetts, Lowell

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 19, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 16, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 25, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17-183-KIM-XPD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings