High Intensity Multi-Modal Exercise Training in Postmenopausal Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2022-06-10

Brief Summary

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in Pakistan 9.9 million people are osteoporotic and 7.2 million amongst them are women. Globally after every 3 seconds there is occurrence of fragility fracture.In Pakistan females carries different risk factors based on distinct culture, environment, diet and lifestyle. So there is dire need to conduct more high quality clinical trials at National level in order to establish strong evidence in favor of low cost but highly effective exercise protocols for such a significant public health issue.

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Detailed Description

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In postmenopausal age, women bones get weak and easily fracture after 50years. In Pakistan every other female is silently suffering from this disease leading to bone, joint pain and disability. This project is innovatively designed first time in Pakistan to target weak bones of women with high intensity, progressive exercise training. The objectives of this study are to determine the effects of a high intensity multi-modal exercise training on bone mineral density and functional performance in postmenopausal women.

After initial screening based on history, subjective fracture risk calculations and subjective osteoporosis screening. Females fulfilling criteria and willing to participate in exercise trial will be recruited in the study. At baseline, DEXA scan will be done for Femoral and lumbar bone density. All performance based testing for functional performance outcome measures would be done at baseline, after 3 months \& after 6 months. Patient will be called twice a week for 8months and DEXA will be repeated after 8months of training. It is hypothesized that supervised exercise training will improve bone mineral density and functional performance in postmenopausal women with low bone mass.

Conditions

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Postmenopausal Osteoporosis Postmenopausal Osteopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This will be a Single factor, Pretest-Postest Control group Design with parallel assignment of patients into two groups.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Females participating in a clinical trial will be kept blind with respect to their allocated exercise group. The assessor doing reporting for the DEXA scan will also be kept blind about the patient group.

Study Groups

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HIT-MMEX Group

In this group Supervised High intensity Progressive Resistance Training, High intensity weightbearing/Impact exercises and High challenging Balance Training will be given. 2 times/week for 40-50minutes session progressively over the duration of 8 months.

Group Type EXPERIMENTAL

High Intensity Exercises

Intervention Type OTHER

Supervised High intensity Progressive Resistance Training, High intensity weightbearing/Impact exercises and High challenging Balance Training will be given. 2 times/week for 40-50minutes session progressively over the duration of 8 months.

Control Group

In this Group Supervised general fitness exercises including general body stretches, treadmill walking, mild to moderate intensity progressive resistance training \& balance exercises will be given. 2 times/week for 40-50minutes session progressively over the duration of 8 months.

Group Type ACTIVE_COMPARATOR

General Exercises

Intervention Type OTHER

Supervised general fitness exercises including general body stretches, treadmill walking, mild to moderate intensity progressive resistance training \& balance exercises will be given. 2 times/week for 40-50minutes session progressively over the duration of 8 months

Interventions

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High Intensity Exercises

Supervised High intensity Progressive Resistance Training, High intensity weightbearing/Impact exercises and High challenging Balance Training will be given. 2 times/week for 40-50minutes session progressively over the duration of 8 months.

Intervention Type OTHER

General Exercises

Supervised general fitness exercises including general body stretches, treadmill walking, mild to moderate intensity progressive resistance training \& balance exercises will be given. 2 times/week for 40-50minutes session progressively over the duration of 8 months

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Postmenopausal Women, at least 3 years since last mensuration.
* Age: 45-70years
* Body mass index (BMI) \<30kg/m2
* Community ambulant without walking aid
* Good general health
* Willing for exercise therapy

Exclusion Criteria

* History of fragility fracture in addition to BMD T-score of -2.5 or less
* MMSE \< 20
* Taking Hormone replacement therapy or steroids from last 1 year.
* Had participated in regular exercise for last 1 year
* Systemic illness: hyperthyroidism, hyperparathyroidism, Diabetes Mellitus, renal failure, any malignancy, extensive radiation exposure
* Any orthopedic injury/disorder hindering performance of exercise.

Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes