Effects of High Intensity Multi-Modal Exercise Training on Bone Density and Functional Performance in Postmenopausal Women
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 58
- Locations
- 2
- Primary Endpoint
- Femoral Neck BMD (FN BMD)
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 45 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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.
Intervention: High Intensity Exercises (Other)
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.
Intervention: General Exercises (Other)
Outcomes
Primary Outcomes
Femoral Neck BMD (FN BMD)
Time Frame: 8 Months
Change from Baseline in Femoral Neck Bone Mineral Density measured by DEXA scan
Lumbar Spine BMD (LS BMD)
Time Frame: 8 Months
Change from Baseline in Lumbar Spine Bone Mineral Density measured by DEXA scan
Secondary Outcomes
- 30-second sit to stand test (Reps)(6 Months)
- Berg balance scale(6 Months)
- Time up and Go test(6 Months)
- Dynamic Gait Index(6 Months)
- 1 RM for Trunk Extensors(6 Months)
- Functional Reach Test (FRT)(6 Months)
- 1 RM for Leg Extensors(6 Months)
- Falls Efficacy Scale(6 Months)
- 1 RM for Leg Extensors(3 Months)
- 1 RM for Trunk Extensors(3 Months)
- 30-second sit to stand test (Reps)(3 Months)
- Time up and Go test(3 Months)
- Dynamic Gait Index(3 Months)
- Falls Efficacy Scale(3 Months)
- Berg balance scale(3 Months)
- Functional Reach Test (FRT)(3 Months)
Investigators
Huma Riaz
Associate Professor
Riphah International University