High Intensity Resistance Training In Postmenopausal Women (HIRT) (HIRT)

Effects of High Intensity Resistance Training in Postmenopausal Women

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.

Study Overview

• Status: Completed
• Conditions: Post Menopause
• Intervention / Treatment: Other: High Intensity Resistance Training (HIRT); Other: Low-moderate Resistance Exercise Training

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Rawalpindi, Punjab, Pakistan, 44000
      • Riphah Rehabilitation Center, RCRAHS Westridge campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Intensity Resistance Training (HIRT); In this HIRT group, participants will perform warm-up activity for 15 minutes then high intensity resistance exercises with 120 seconds of rest interval between each set of exercise and between exercises respectively. After that, generalized stretching exercises as a cool down activity will be performed by the participants. Participants will perform exercises twice weekly, 40-50 minutes/session for 12 weeks under supervision.	Other: High Intensity Resistance Training (HIRT); High Intensity Resistance Exercises Supervised High Intensity Resistance Training with 15 minutes of cycling as a warm-up activity then HIRT through Quadriceps drill, Squats, Lunges, Leg press, Biceps curls and Deadlift with 120 seconds of rest interval between each set of exercise and between exercises will be performed by the participants with appropriate cool down through generalized stretching exercises. Participants will perform exercises twice weekly, 40-50 minutes/session for 12 weeks respectively.
Active Comparator: Low-moderate Resistance Exercise Training; In this low-moderate resistance training group, participants will perform warm-up activity for 15 minutes then low-moderate intensity resistance exercises with 120 seconds of rest interval between each set of exercise and between exercises respectively. After that, generalized stretching exercises as a cool down activity will be performed by the participants. Participants will perform exercises twice weekly, 40-50 minutes/session for 12 weeks under supervision.	Other: Low-moderate Resistance Exercise Training; Supervised Low-moderate Resistance Training with 15 minutes of cycling as a warm-up activity then Quadriceps drill, Squats, Lunges, Leg press, Biceps curls and Deadlift with 120 seconds of rest interval between each set of exercise and between exercises will be performed by the participants with appropriate cool down through generalized stretching exercises. Participants will perform exercises twice weekly, 40-50 minutes/session for 12 weeks respectively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
10RM leg press	Assessed from baseline. 10 RM is used to assess maximum muscle strength that is to extend knee 10 times against maximum resistance. Weight will be recorded in Kgs. [Time Frame: 3 Months]	3 months
10RM dead lift (kg)	Assessed from baseline. 10 RM is used to assess maximum muscle strength that is to lift weight 10 times against maximum resistance. Weight will be recorded in Kgs.	3 months
Sit and reach test (cm)	Assessed from baseline. It is linear flexibility test used to measure extensibility of hamstrings and lower back. Participant will perform test in seated position with extended knees, distance between extended fingers and top of the toe will be recorded in cm.	3 months
Sit and stand test (reps)	Assessed from baseline. In this test participant will rise to full standing position from seated position without using armrests of chair and researcher will count the number of complete stand from sitting position within 30 seconds. Inaccurately accomplished stands will not be counted.	3 months
Plank test (sec)	Assessed from baseline. It is fitness test that measures the endurance of core stabilizing muscles. Participants will be in prone position with elbow flexion at 90° and forearm resting on floor and toes touching the floor. Two trials will be recorded with 1.5 minutes of rest interval between attempts and extensive isometric time will be used for analysis.	3 months
6 - minutes' walk test (sec)	Assessed from baseline. It is sub-maximal exercise test used to evaluate aerobic capacity and endurance. Participant will walk in 30-metre walkway with marked ends for 6 minutes. Patient will be permitted to slow down, stop or rest when required. Record the distance walked in 6 minutes' duration with vital signs monitoring.	3 months
Gait speed	Assessed from baseline. Gait speed test is used to assess functional mobility of an individual. Gait speed will be measured from 6-m distance in 10-m track using stopwatch with 2 meters for acceleration and 2 meters for deceleration respectively. Two trials will be performed and then average score will be taken for analysis. Participant will start walking with dominant foot with maximum pace possible.	3 months
Menopause specific Quality of life (MENQOL)	Assessed from baseline. Menopause specific Quality of life is the tool used to assess quality of life among postmenopausal women in the past month. It has four domains of menopausal symptoms; vasomotor, psychosocial, physical and sexual. A total of 29 items in a 6 point Likert-scale is used, with 0 means not at all bothered and 6 means extremely bothered. the minimum score is 0 and maximum is 174.	3 months

Collaborators and Investigators

• Sponsor: Riphah International University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): December 15, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: September 13, 2021
• First Submitted That Met QC Criteria: September 13, 2021
• First Posted (Actual): September 22, 2021

Study Record Updates

• Last Update Posted (Actual): February 2, 2022
• Last Update Submitted That Met QC Criteria: February 1, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: REC/00915 Qurat-ul-Ain

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No