High Intensity Resistance Training In Postmenopausal Women (HIRT)

NCT05052749 | Completed

• 1 other identifier: REC/00915 Qurat-ul-Ain
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Menopause

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

High Intensity Resistance Training (HIRT)

EXPERIMENTAL

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)

Low-moderate Resistance Exercise Training

ACTIVE COMPARATOR

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

Interventions

High Intensity Resistance Training (HIRT) OTHER

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.

High Intensity Resistance Training (HIRT)

Low-moderate Resistance Exercise Training OTHER

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.

Low-moderate Resistance Exercise Training

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
• Age: 45-70 years
• Sedentary life style

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah Rehabilitation Center, RCRAHS Westridge campus

Rawalpindi, Punjab Province, 44000, Pakistan

Location

Related Publications (6)

• 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.

  PMID: 31588031 BACKGROUND

• 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.

  PMID: 29393299 BACKGROUND

• 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.

  PMID: 27567125 BACKGROUND

• 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.

  PMID: 30503353 BACKGROUND

• 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.

  PMID: 27095955 BACKGROUND

• 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.

  PMID: 32592830 BACKGROUND

Study Officials

• Huma Riaz, PHD*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Female participants in clinical trial will be kept blind about their exercise group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a single factor, Pretest-Posttest Control Group Design with parallel assignment of patients in to two groups.

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: September 22, 2021
• Study Start: March 1, 2021
• Primary Completion: December 15, 2021
• Study Completion: December 31, 2021
• Last Updated: February 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)