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Completed

NCT Number: NCT04653350

High Intensity Multi-Modal Exercise Training in Postmenopausal Women

in Pakistan 9.9 million people are osteoporotic and 7.2 million amongst them are women. Globally after every 3 seconds there is occurrence of fragility fracture.In Pakistan females carries different risk factors based on distinct culture, environment, diet and lifestyle. So there is dire need to conduct more high quality clinical trials at National level in order to establish strong evidence in favor of low cost but highly effective exercise protocols for such a significant public health issue.

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Key information

Conditions

Postmenopausal Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal Postmenopausal Osteopenia

Age range

45 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Behbud Association of Pakistan, Rawalpindi, Punjab Province, Pakistan

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About this study

In postmenopausal age, women bones get weak and easily fracture after 50years. In Pakistan every other female is silently suffering from this disease leading to bone, joint pain and disability. This project is innovatively designed first time in Pakistan to target weak bones of women with high intensity, progressive exercise training. The objectives of this study are to determine the effects of a high intensity multi-modal exercise training on bone mineral density and functional performance in postmenopausal women.

After initial screening based on history, subjective fracture risk calculations and subjective osteoporosis screening. Females fulfilling criteria and willing to participate in exercise trial will be recruited in the study. At baseline, DEXA scan will be done for Femoral and lumbar bone density. All performance based testing for functional performance outcome measures would be done at baseline, after 3 months & after 6 months. Patient will be called twice a week for 8months and DEXA will be repeated after 8months of training. It is hypothesized that supervised exercise training will improve bone mineral density and functional performance in postmenopausal women with low bone mass.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Postmenopausal Women, at least 3 years since last mensuration.
  • Age: 45-70years
  • Body mass index (BMI) <30kg/m2
  • Community ambulant without walking aid
  • Good general health
  • Willing for exercise therapy

Exclusion criteria

  • History of fragility fracture in addition to BMD T-score of -2.5 or less
  • MMSE < 20
  • Taking Hormone replacement therapy or steroids from last 1 year.
  • Had participated in regular exercise for last 1 year
  • Systemic illness: hyperthyroidism, hyperparathyroidism, Diabetes Mellitus, renal failure, any malignancy, extensive radiation exposure
  • Any orthopedic injury/disorder hindering performance of exercise.

Treatment and study plan

High Intensity Exercises

Other

Supervised High intensity Progressive Resistance Training, High intensity weightbearing/Impact exercises and High challenging Balance Training will be given. 2 times/week for 40-50minutes session progressively over the duration of 8 months.

General exercises

Other

Supervised general fitness exercises including general body stretches, treadmill walking, mild to moderate intensity progressive resistance training & balance exercises will be given. 2 times/week for 40-50minutes session progressively over the duration of 8 months

Primary outcomes

  1. Femoral Neck BMD (FN BMD)

    Time frame: 8 Months

    Change from Baseline in Femoral Neck Bone Mineral Density measured by DEXA scan

  2. Lumbar Spine BMD (LS BMD)

    Time frame: 8 Months

    Change from Baseline in Lumbar Spine Bone Mineral Density measured by DEXA scan

Secondary outcomes

  1. 1 RM for Leg Extensors

    Time frame: 3 Months

    Changes from the baseline, 1 RM Is used to assess maximum muscle strength. Patient will be asked to perform leg press that is to extend knee against maximum resistance once. weight will be recorded in Kgs.

  2. 1 RM for Leg Extensors

    Time frame: 6 Months

    Changes from 3 Months, 1 RM Is used to assess maximum muscle strength. Patient will be asked to perform leg press that is to extend knee against maximum resistance once. weight will be recorded in Kgs.

  3. 1 RM for Trunk Extensors

    Time frame: 3 Months

    Changes Baseline, 1 RM Is used to assess maximum muscle strength. Patient will be asked to perform deadlift, maximum weight lifted will be recorded in Kgs.

  4. 1 RM for Trunk Extensors

    Time frame: 6 Months

    Changes from 3 Months, 1 RM Is used to assess maximum muscle strength. Patient will be asked to perform deadlift, maximum weight lifted will be recorded in Kgs.

  5. 30-second sit to stand test (Reps)

    Time frame: 3 Months

    Changes from Baseline, It involves counting the number of times the participant can rise to a full standing position from the seated position on a chair without using the arms

  6. 30-second sit to stand test (Reps)

    Time frame: 6 Months

    Changes from 3 Months, It involves counting the number of times the participant can rise to a full standing position from the seated position on a chair without using the arms

  7. Time up and Go test

    Time frame: 3 Months

    Changes from Baseline, participants will be instructed to walk at usual speed for three meter and then walk back to sit down .Note time on stopwatch .The average of tests trail will be measured as the mean of TUG.

  8. Time up and Go test

    Time frame: 6 Months

    Changes from 3 Months, participants will be instructed to walk at usual speed for three meter and then walk back to sit down .Note time on stopwatch .The average of tests trail will be measured as the mean of TUG.

  9. Dynamic Gait Index

    Time frame: 3 Months

    Changes from Baseline, DGI was Developed to assess the likelihood of falling in older adults. Designed to test eight facets of gait. A four-point ordinal scale, ranging from 0-3. "0" indicates the lowest level of function and "3" the highest level of function. Total Score is 24

  10. Dynamic Gait Index

    Time frame: 6 Months

    Changes from 3 months, DGI was Developed to assess the likelihood of falling in older adults. Designed to test eight facets of gait. A four-point ordinal scale, ranging from 0-3. "0" indicates the lowest level of function and "3" the highest level of function. Total Score is 24

  11. Falls Efficacy Scale

    Time frame: 3 Months

    Changes from Baseline, On a scale from 1 to 10, with 1 being very confident and 10 being not confident at all, patient will be asked how confident are you that you do the given activities without falling. A total score of greater than 70 indicates that the person has a fear of falling.

  12. Falls Efficacy Scale

    Time frame: 6 Months

    Changes from 3Months, On a scale from 1 to 10, with 1 being very confident and 10 being not confident at all, patient will be asked how confident are you that you do the given activities without falling. A total score of greater than 70 indicates that the person has a fear of falling.

  13. Berg balance scale

    Time frame: 3 Months

    Changes from Baseline, The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait.

  14. Berg balance scale

    Time frame: 6 Months

    Changes from 3Months, The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait.

  15. Functional Reach Test (FRT)

    Time frame: 3 Months

    Changes from Baseline, it is a clinical outcome measure and assessment tool for ascertaining dynamic balance in one simple task.In standing, measures the distance between the length of an outstretched arm in a maximal forward reach, while maintaining a fixed base of support.

  16. Functional Reach Test (FRT)

    Time frame: 6 Months

    Changes from 3 months, it is a clinical outcome measure and assessment tool for ascertaining dynamic balance in one simple task.In standing, measures the distance between the length of an outstretched arm in a maximal forward reach, while maintaining a fixed base of support.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of High Intensity Multi-Modal Exercise Training on Bone Density and Functional Performance in Postmenopausal Women

Acronym: HIT-MMEX

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 4, 2020
Registry last updated
Jun 21, 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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