High Intensity Multi-Modal Exercise Training in Postmenopausal Women

NCT04653350 | Completed

• 1 other identifier: RiphahIU Huma Riaz
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 2

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.

Conditions

Postmenopausal Osteoporosis; Postmenopausal Osteopenia

Outcome Measures

Primary Outcomes (2)

• Femoral Neck BMD (FN BMD)

  Change from Baseline in Femoral Neck Bone Mineral Density measured by DEXA scan

  8 Months

• Lumbar Spine BMD (LS BMD)

  Change from Baseline in Lumbar Spine Bone Mineral Density measured by DEXA scan

  8 Months

Secondary Outcomes (16)

• 1 RM for Leg Extensors

  3 Months

• 1 RM for Leg Extensors

  6 Months

• 1 RM for Trunk Extensors

  3 Months

• 1 RM for Trunk Extensors

  6 Months

• 30-second sit to stand test (Reps)

  3 Months

Study Arms (2)

HIT-MMEX Group

EXPERIMENTAL

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.

Other: High Intensity Exercises

Control Group

ACTIVE COMPARATOR

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.

Other: General Exercises

Interventions

High Intensity Exercises 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.

HIT-MMEX Group

General Exercises 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

Control Group

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (2)

Rehab Center RCRAHS Potohar campus

Rawalpindi, Punjab Province, 40100, Pakistan

Location

Behbud Association of Pakistan

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Related Publications (7)

• 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.

  PMID: 22640372 BACKGROUND

• 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.

  PMID: 28975661 BACKGROUND

• 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.

  PMID: 30861219 BACKGROUND

• 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.

  PMID: 26243363 BACKGROUND

• 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.

  PMID: 30612163 BACKGROUND

• 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.

  PMID: 21113584 BACKGROUND

• Riaz H, Babur MN, Farooq A. Effects of high-intensity multi-modal exercise training (HIT-MMEX) on bone mineral density and muscle performance in postmenopausal women. A Pilot randomized controlled trial. J Pak Med Assoc. 2022 Oct;72(10):1904-1908. doi: 10.47391/JPMA.5394.

  PMID: 36660974 DERIVED

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Huma Riaz, Phd*

  Riphah International University

  PRINCIPAL INVESTIGATOR

• Muhammad Naveed Babur, Phd

  Isra University islamabad

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

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

Study Record Dates

• First Submitted: November 26, 2020
• First Posted: December 4, 2020
• Study Start: November 1, 2020
• Primary Completion: June 10, 2022
• Study Completion: June 10, 2022
• Last Updated: June 21, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)