High Intensity Resistance Training In Postmenopausal Women (HIRT)

NCT ID: NCT05052749

Last Updated: 2022-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post Menopause

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This will be a single factor, Pretest-Posttest Control Group Design with parallel assignment of patients in to two groups.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Female participants in clinical trial will be kept blind about their exercise group allocation.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

High Intensity Resistance Training (HIRT)

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Low-moderate Resistance Exercise Training

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Riphah International University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Huma Riaz, PHD*

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Riphah Rehabilitation Center, RCRAHS Westridge campus

Rawalpindi, Punjab Province, Pakistan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 31588031 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29393299 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27567125 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30503353 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27095955 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32592830 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

REC/00915 Qurat-ul-Ain

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.