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Completed

NCT Number: NCT05052749

High Intensity Resistance Training In Postmenopausal Women (HIRT)

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.

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Key information

Conditions

Post Menopause

Age range

45 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Riphah Rehabilitation Center, RCRAHS Westridge campus

Rawalpindi, Punjab Province, 44000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 10RM leg press

    Time frame: 3 months

    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]

  2. 10RM dead lift (kg)

    Time frame: 3 months

    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. Sit and reach test (cm)

    Time frame: 3 months

    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.

  4. Sit and stand test (reps)

    Time frame: 3 months

    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.

  5. Plank test (sec)

    Time frame: 3 months

    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.

  6. 6 - minutes' walk test (sec)

    Time frame: 3 months

    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.

  7. Gait speed

    Time frame: 3 months

    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.

  8. Menopause specific Quality of life (MENQOL)

    Time frame: 3 months

    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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of High Intensity Resistance Training in Postmenopausal Women

Acronym: HIRT

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 22, 2021
Registry last updated
Feb 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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