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

Primary Purpose

Osteoporosis, Cardiovascular Risk Factor

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga group
Sponsored by
University of Massachusetts, Lowell
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis focused on measuring Yoga, Bone markers, Arterial stiffness, Premenopausal women

Eligibility Criteria

30 Years - 48 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Massachusetts

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Yoga group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
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.
Change in menstrual history was assessed
A menstrual history questionnaire (MH) was used to determine if a participant was pregnant.
Change in calcium intake was assessed
Daily calcium intake (mg/d) was estimated using a calcium intake questionnaire (CI).
Change in Body Mass Index (BMI) was assessed
Height (cm) and weight (kg) were collected to calculate BMI (kg/m2).
Change in total fat mass was assessed
Total fat mass (g) was measured using Dual Energy-X-ray Absorptiometry.
Change in bone free lean body mass was assessed
Bone free lean body mass (g) was measured using Dual Energy-X-ray Absorptiometry.
Change in %fat was assessed
%fat (%) was measured using Dual Energy-X-ray Absorptiometry.
Change in P1NP was assessed.
A blood draw (approximately 10 ml) was collected to investigate differences in bone formation marker (P1NP, ng/mL)
Change in CTX was assessed
A blood draw (approximately 10 ml) was collected to investigate differences in bone resorption marker (CTX, ng/mL)

Secondary Outcome Measures

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

Full Information

First Posted
April 10, 2020
Last Updated
April 16, 2020
Sponsor
University of Massachusetts, Lowell
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1. Study Identification

Unique Protocol Identification Number
NCT04353700
Brief Title
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

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
September 19, 2018 (Actual)
Primary Completion Date
February 16, 2019 (Actual)
Study Completion Date
September 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Lowell

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Cardiovascular Risk Factor
Keywords
Yoga, Bone markers, Arterial stiffness, Premenopausal women

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants were randomly assigned either a yoga intervention group or a control group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yoga group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Yoga group
Intervention Description
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 Outcome Measure Information:
Title
Change in Physical activity participation was assessed.
Description
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).
Time Frame
BPAQ scores were collected at baseline, at 6 weeks, and after 12 weeks to see any differences throughout the intervention periods.
Title
Change in Health history was assessed.
Description
A health history questionnaire (HH) was utilized to examine any medical history that can affect bone and cardiovascular health.
Time Frame
HH questionnaires were collected at baseline, at 6 weeks, and after 12 weeks to see any changes throughout the intervention periods.
Title
Change in menstrual history was assessed
Description
A menstrual history questionnaire (MH) was used to determine if a participant was pregnant.
Time Frame
MH questionnaires were collected at baseline, at 6 weeks, and after 12 weeks to see any changes throughout the intervention periods.
Title
Change in calcium intake was assessed
Description
Daily calcium intake (mg/d) was estimated using a calcium intake questionnaire (CI).
Time Frame
CI questionnaires were collected at baseline, at 6 weeks, and after 12 weeks to see any changes throughout the intervention periods.
Title
Change in Body Mass Index (BMI) was assessed
Description
Height (cm) and weight (kg) were collected to calculate BMI (kg/m2).
Time Frame
Height and weight were collected at baseline and after 12 weeks.
Title
Change in total fat mass was assessed
Description
Total fat mass (g) was measured using Dual Energy-X-ray Absorptiometry.
Time Frame
Total fat mass was measured at baseline and after 12 weeks.
Title
Change in bone free lean body mass was assessed
Description
Bone free lean body mass (g) was measured using Dual Energy-X-ray Absorptiometry.
Time Frame
Bone free lean body mass was measured at baseline and after 12 weeks.
Title
Change in %fat was assessed
Description
%fat (%) was measured using Dual Energy-X-ray Absorptiometry.
Time Frame
%fat was measured at baseline and after 12 weeks.
Title
Change in P1NP was assessed.
Description
A blood draw (approximately 10 ml) was collected to investigate differences in bone formation marker (P1NP, ng/mL)
Time Frame
Blood draws were collected at baseline, at 6 weeks, and after 12 weeks.
Title
Change in CTX was assessed
Description
A blood draw (approximately 10 ml) was collected to investigate differences in bone resorption marker (CTX, ng/mL)
Time Frame
Blood draws were collected at baseline, at 6 weeks, and after 12 weeks.
Secondary Outcome Measure Information:
Title
Change in Arterial stiffness was assessed
Description
Arterial stiffness (m/s) was measured using Pulse Wave Velocity (PWV) to look at intervention effects.
Time Frame
Arterial stiffness was collected at baseline, at 6 weeks, and after 12 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Females who have regular menstrual cycles
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SoJung Kim, PhD
Organizational Affiliation
University of Massachusetts, Lowell
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Massachusetts
City
Lowell
State/Province
Massachusetts
ZIP/Postal Code
01854
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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