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

NCT04353700 | Completed

• 1 other identifier: 17-183-KIM-XPD
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis; Cardiovascular Risk Factor

Keywords

Yoga; Bone markers; Arterial stiffness; Premenopausal women

Outcome Measures

Primary Outcomes (10)

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• Change in %fat was assessed

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

  %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)

  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)

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

Secondary Outcomes (1)

• Change in Arterial stiffness was assessed

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

Study Arms (2)

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.

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.

Interventions

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.

Yoga group

Eligibility Criteria

• Age: 30 Years - 48 Years
• Gender Eligibility Details: Females who have regular menstrual cycles
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Massachusetts, Lowell: lead

Study Sites (1)

University of Massachusetts

Lowell, Massachusetts, 01854, United States

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• SoJung Kim, PhD

  University of Massachusetts, Lowell

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants were randomly assigned either a yoga intervention group or a control group.

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 20, 2020
• Study Start: September 19, 2018
• Primary Completion: February 16, 2019
• Study Completion: September 25, 2019
• Last Updated: April 20, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)