Clinical trial NCT04653350: High Intensity Multi-Modal Exercise Training in Postmenopausal Women
Official title: Effects of High Intensity Multi-Modal Exercise Training on Bone Density and Functional Performance in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postmenopausal Osteoporosis
Postmenopausal Osteopenia
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2020-12-04
Enrollment: 58
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be a Single factor, Pretest-Postest Control group Design with parallel assignment of patients into two groups.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Femoral Neck BMD (FN BMD)
timeFrame: 8 Months
measure: Lumbar Spine BMD (LS BMD)
timeFrame: 8 Months
Secondary outcomes:
measure: 1 RM for Leg Extensors
timeFrame: 3 Months
measure: 1 RM for Leg Extensors
timeFrame: 6 Months
measure: 1 RM for Trunk Extensors
timeFrame: 3 Months
measure: 1 RM for Trunk Extensors
timeFrame: 6 Months
measure: 30-second sit to stand test (Reps)
timeFrame: 3 Months
measure: 30-second sit to stand test (Reps)
timeFrame: 6 Months
measure: Time up and Go test
timeFrame: 3 Months
measure: Time up and Go test
timeFrame: 6 Months
measure: Dynamic Gait Index
timeFrame: 3 Months
measure: Dynamic Gait Index
timeFrame: 6 Months
measure: Falls Efficacy Scale
timeFrame: 3 Months
measure: Falls Efficacy Scale
timeFrame: 6 Months
measure: Berg balance scale
timeFrame: 3 Months
measure: Berg balance scale
timeFrame: 6 Months
measure: Functional Reach Test (FRT)
timeFrame: 3 Months
measure: Functional Reach Test (FRT)
timeFrame: 6 Months
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Rehab Center RCRAHS Potohar campus
state: Punjab
city: Rawalpindi
country: Pakistan
facility: Behbud Association of Pakistan
state: Punjab
Study officials:
affiliation: Riphah International University
name: Huma Riaz, Phd*
role: PRINCIPAL_INVESTIGATOR
affiliation: Isra University islamabad
name: Muhammad Naveed Babur, Phd
role: STUDY_CHAIR
References:
citation: Gianoudis J, Bailey CA, Sanders KM, Nowson CA, Hill K, Ebeling PR, Daly RM. Osteo-cise: strong bones for life: protocol for a community-based randomised controlled trial of a multi-modal exercise and osteoporosis education program for older adults at risk of falls and fractures. BMC Musculoskelet Disord. 2012 May 28;13:78. doi: 10.1186/1471-2474-13-78.
citation: Watson SL, Weeks BK, Weis LJ, Harding AT, Horan SA, Beck BR. High-Intensity Resistance and Impact Training Improves Bone Mineral Density and Physical Function in Postmenopausal Women With Osteopenia and Osteoporosis: The LIFTMOR Randomized Controlled Trial. J Bone Miner Res. 2018 Feb;33(2):211-220. doi: 10.1002/jbmr.3284. Epub 2017 Oct 4.
citation: Watson S, Weeks B, Weis L, Harding A, Horan S, Beck B. High-Intensity Resistance and Impact Training Improves Bone Mineral Density and Physical Function in Postmenopausal Women With Osteopenia and Osteoporosis: The LIFTMOR Randomized Controlled Trial. J Bone Miner Res. 2019 Mar;34(3):572. doi: 10.1002/jbmr.3659. Epub 2019 Feb 25. No abstract available.
citation: Watson SL, Weeks BK, Weis LJ, Horan SA, Beck BR. Heavy resistance training is safe and improves bone, function, and stature in postmenopausal women with low to very low bone mass: novel early findings from the LIFTMOR trial. Osteoporos Int. 2015 Dec;26(12):2889-94. doi: 10.1007/s00198-015-3263-2. Epub 2015 Aug 5.
citation: Watson SL, Weeks BK, Weis LJ, Harding AT, Horan SA, Beck BR. High-intensity exercise did not cause vertebral fractures and improves thoracic kyphosis in postmenopausal women with low to very low bone mass: the LIFTMOR trial. Osteoporos Int. 2019 May;30(5):957-964. doi: 10.1007/s00198-018-04829-z. Epub 2019 Jan 5.
citation: Marques EA, Mota J, Machado L, Sousa F, Coelho M, Moreira P, Carvalho J. Multicomponent training program with weight-bearing exercises elicits favorable bone density, muscle strength, and balance adaptations in older women. Calcif Tissue Int. 2011 Feb;88(2):117-29. doi: 10.1007/s00223-010-9437-1. Epub 2010 Nov 27.