OsteoporosisNCT04353700
Effects of a 12-week Home-based Yoga on Bone and Cardiovascular Health
A study testing Yoga group in people with Osteoporosis and Cardiovascular Risk Factor, run by University of Massachusetts, Lowell at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 30 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Cardiovascular Risk Factor
- What is being tested?
- Yoga group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2018to 25 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 48 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts
Lowell, Massachusetts, 01854
About this study
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
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.
Read the 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.
- Conditions
- Osteoporosis, Cardiovascular Risk Factor
- Being tested
- Yoga group
- Keywords
- Yoga, Bone markers, Arterial stiffness, Premenopausal women
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Yoga group | Active comparator | 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. Receives: Behavioral: Yoga group |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
A health history questionnaire (HH) was utilized to examine any medical history that can affect bone and cardiovascular health.
Measured: 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
A menstrual history questionnaire (MH) was used to determine if a participant was pregnant.
Measured: 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
Daily calcium intake (mg/d) was estimated using a calcium intake questionnaire (CI).
Measured: 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
Height (cm) and weight (kg) were collected to calculate BMI (kg/m2).
Measured: Height and weight were collected at baseline and after 12 weeks.
Change in total fat mass was assessed
Total fat mass (g) was measured using Dual Energy-X-ray Absorptiometry.
Measured: Total fat mass was measured at baseline and after 12 weeks.
Change in bone free lean body mass was assessed
Bone free lean body mass (g) was measured using Dual Energy-X-ray Absorptiometry.
Measured: Bone free lean body mass was measured at baseline and after 12 weeks.
Change in %fat was assessed
%fat (%) was measured using Dual Energy-X-ray Absorptiometry.
Measured: %fat was measured at baseline and after 12 weeks.
Change in P1NP was assessed.
A blood draw (approximately 10 ml) was collected to investigate differences in bone formation marker (P1NP, ng/mL)
Measured: Blood draws were collected at baseline, at 6 weeks, and after 12 weeks.
Change in CTX was assessed
A blood draw (approximately 10 ml) was collected to investigate differences in bone resorption marker (CTX, ng/mL)
Measured: Blood draws were collected at baseline, at 6 weeks, and after 12 weeks.
Secondary outcomes (1)
Change in Arterial stiffness was assessed
Arterial stiffness (m/s) was measured using Pulse Wave Velocity (PWV) to look at intervention effects.
Measured: Arterial stiffness was collected at baseline, at 6 weeks, and after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start19 Sep 2018
- Primary completion16 Feb 2019
- Study completion25 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned either a yoga intervention group or a control group.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Lowell
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SoJung Kim, University of Massachusetts, Lowell
- Investigators
- SoJung Kim, PhD, Principal investigator, University of Massachusetts, Lowell
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04353700
- Sponsor's protocol ID
- 17-183-KIM-XPD
- Status last verified
- Apr 2020
- First submitted
- 10 Apr 2020
- Last updated
- 20 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04353700
- Acronym / sponsor ID
- 17-183-KIM-XPD
- Conditions
- Osteoporosis, Cardiovascular Risk Factor
- Keywords
- Yoga, Bone markers, Arterial stiffness, Premenopausal women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of Massachusetts, LowellUniversity, hospital or other
- Study start
- 19 Sep 2018 (actual)
- Primary completion
- 16 Feb 2019 (actual)
- Study completion
- 25 Sep 2019 (actual)
- First posted
- 20 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned either a yoga intervention group or a control group.
| Arm | Type | Receives |
|---|---|---|
| Yoga group | Active comparator | Behavioral: Yoga groupA 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 30 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga groupDuring 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. | Behavioural | Yoga group |
Primary outcome
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).
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.
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.
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).
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).
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.
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.
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.
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)
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)
1 secondary outcome
Change in Arterial stiffness was assessed
Time frame: Arterial stiffness was collected at baseline, at 6 weeks, and after 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SoJung Kim, PhD principal investigator
University of Massachusetts, Lowell
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga group in people with Osteoporosis and Cardiovascular Risk Factor, run by University of Massachusetts, Lowell at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2020.