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Improving bone health and quality of life with Yoga cum Life Style Model among menopausal women in low income populatio

Not Applicable
Conditions
Health Condition 1: M810- Age-related osteoporosis without current pathological fracture
Registration Number
CTRI/2019/09/021328
Lead Sponsor
Department of Health Research
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

Inclusion criteria :

Women aged 50 - 65 years,

Menopausal at least since 5 years

Diagnosed as osteoporosis at femur or lumbar spine using DXA

Normal ECG findings

Cognitive, able to do their day to day activities,

Not willing to take antiresorptive medicines

Physically able to participate in the study for 2 years duration,

Willing to undergo dietary modifications and maintain log of the same

Willing to undergo exercise along with yoga on daily basis and under supervision on weekly basis

Undergone the 3-month exercise and yoga course at the community hall

Staying nearby and willing to sign the informed consent form.

Exclusion Criteria

Women with systemic diseases like cardiac, cancer and other debilitating diseases, or with secondary osteoporosis

Undergoing daily exercise and yoga since the past one year

Use of medications like steroids, anticonvulsant or bisphosphonates, SERMs etc, or on any treatment for osteoporosis

Lowest T scores at any one site spine/hip below - 3.5

History of any atraumatic fractures like wrist, vertebral fractures etc

Non-ambulatory women

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Primary Outcome Measures- Impact on bone health: <br/ ><br>Increase in bone mineral density over the time period from baseline to 12, and 24 months due to intervention model <br/ ><br>Changes in bone turnover markers over the time period from baseline to 6, 12, and 24 months due to intervention model <br/ ><br>Timepoint: Primary Outcome Measures- Impact on bone health: <br/ ><br>Increase in bone mineral density over the time period from baseline to 12, and 24 months due to intervention model <br/ ><br>Changes in bone turnover markers over the time period from baseline to 6, 12, and 24 months due to intervention model <br/ ><br>
Secondary Outcome Measures
NameTimeMethod
Quality of life Changes ( Time Frame: baseline, 6,12,18, and 24 months ) <br/ ><br>Compliance with dietary modifications along with calcium and vitamin D supplementation <br/ ><br>Compliance with physical activity and yoga i.e. intervention model acceptability and feasibility <br/ ><br>Timepoint: 0,6,12,18,24 months since recritement
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