Clinical trial NCT05052749: High Intensity Resistance Training In Postmenopausal Women (HIRT)
Official title: Effects of High Intensity Resistance Training in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Menopause
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-09-22
Enrollment: 40
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-Posttest Control Group Design with parallel assignment of patients in to two groups.
Primary purpose: TREATMENT

Brief summary: Menopause is defined as a permanent cessation of menstrual cycle for 12 months due to intrinsic diminution of ovarian oocytes among women in older age. Globally reported mean age for menopause is 48.78 years (ranges from 46-52 years). Menopausal age reported among Asian and African population was lower as compared to European women . Among postmenopausal women, age related various central nervous system, musculoskeletal, urogenital, metabolic and skin changes ensue along with osteoporosis (T-score = ≤ -2.5) and decreased bone mineral density due to estrogen deficiency that is directly associated with fragility fractures and disability among this age group. Therefore, recruitment of older adults in resistance training program is crucial in inducing increases in muscle strength and ameliorating glucose tolerance and increased insulin sensitivity along with improvements in BMD and BMR.

Detailed description: Physical activity is extremely crucial in maintaining quality of life and estrogen metabolism among postmenopausal women, owing to the increased risk of falls, age related decline in cardiopulmonary, musculoskeletal endurance and cognitive capacity. In Pakistan, fitness of women specifically of postmenopausal age group is ignored due to some cultural norms. Performance of physical activity in the form of resistance training (RT) is one of the best known methods to improve physical fitness in the elderly. So the current study is planned with objectives to determine effects of High Intensity Resistance Training in Postmenopausal Women. Supervised exercise training will be provided for 3 months and functional performance will be measured accordingly.

After initial screening of postmenopausal women including history and anthropometric details, females meeting inclusion criteria and willing to participate in high intensity resistance exercise trial will be recruited in the study. After that; physical fitness, performance base testing for functional performance outcome measures and MENQOL assessment will be done at baseline and after 3 months. Patients will perform resistance training twice a week, 40-50 min/session for 12 weeks respectively. It is hypothesized that supervised high intensity resistance training will improve functional performance, physical fitness and Quality of life among postmenopausal women.

Eligibility criteria: Inclusion Criteria:

* Postmenopausal women
* Age: 45-70 years
* Sedentary life style

Exclusion Criteria:

* High risk of fracture as calculated by WHO online FRAX tool.
* Presence/history of fragility fracture.
* MMSE \< 20
* Systemic illness: hyperthyroidism, hyperparathyroidism, renal failure, any malignancy, extensive radiation exposure.
* Any orthopedic injury/disorder hindering performance of exercise.
* Not willing for exercise.

Primary outcomes:
measure: 10RM leg press
timeFrame: 3 months
measure: 10RM dead lift (kg)
timeFrame: 3 months
measure: Sit and reach test (cm)
timeFrame: 3 months
measure: Sit and stand test (reps)
timeFrame: 3 months
measure: Plank test (sec)
timeFrame: 3 months
measure: 6 - minutes' walk test (sec)
timeFrame: 3 months
measure: Gait speed
timeFrame: 3 months
measure: Menopause specific Quality of life (MENQOL)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Riphah Rehabilitation Center, RCRAHS Westridge campus
state: Punjab
Study officials:
affiliation: Riphah International University
name: Huma Riaz, PHD*
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhu D, Chung HF, Dobson AJ, Pandeya N, Giles GG, Bruinsma F, Brunner EJ, Kuh D, Hardy R, Avis NE, Gold EB, Derby CA, Matthews KA, Cade JE, Greenwood DC, Demakakos P, Brown DE, Sievert LL, Anderson D, Hayashi K, Lee JS, Mizunuma H, Tillin T, Simonsen MK, Adami HO, Weiderpass E, Mishra GD. Age at natural menopause and risk of incident cardiovascular disease: a pooled analysis of individual patient data. Lancet Public Health. 2019 Nov;4(11):e553-e564. doi: 10.1016/S2468-2667(19)30155-0. Epub 2019 Oct 3.
citation: Monteleone P, Mascagni G, Giannini A, Genazzani AR, Simoncini T. Symptoms of menopause - global prevalence, physiology and implications. Nat Rev Endocrinol. 2018 Apr;14(4):199-215. doi: 10.1038/nrendo.2017.180. Epub 2018 Feb 2.
citation: Maillard F, Rousset S, Pereira B, Traore A, de Pradel Del Amaze P, Boirie Y, Duclos M, Boisseau N. High-intensity interval training reduces abdominal fat mass in postmenopausal women with type 2 diabetes. Diabetes Metab. 2016 Dec;42(6):433-441. doi: 10.1016/j.diabet.2016.07.031. Epub 2016 Aug 24.
citation: Daly RM, Dalla Via J, Duckham RL, Fraser SF, Helge EW. Exercise for the prevention of osteoporosis in postmenopausal women: an evidence-based guide to the optimal prescription. Braz J Phys Ther. 2019 Mar-Apr;23(2):170-180. doi: 10.1016/j.bjpt.2018.11.011. Epub 2018 Nov 22.
citation: Socha M, Fraczak P, Jonak W, Sobiech KA. Effect of resistance training with elements of stretching on body composition and quality of life in postmenopausal women. Prz Menopauzalny. 2016 Mar;15(1):26-31. doi: 10.5114/pm.2016.58770. Epub 2016 Mar 29.
citation: Dias RKN, Penna EM, Noronha ASN, de Azevedo ABC, Barbalho M, Gentil PV, Coswig VS. Cluster-sets resistance training induce similar functional and strength improvements than the traditional method in postmenopausal and elderly women. Exp Gerontol. 2020 Sep;138:111011. doi: 10.1016/j.exger.2020.111011. Epub 2020 Jun 24.