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High Intensity Multi-Modal Exercise Training in Postmenopausal Women (HIT-MMEX)

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ClinicalTrials.gov Identifier: NCT04653350
Recruitment Status : Recruiting
First Posted : December 4, 2020
Last Update Posted : December 7, 2020
Sponsor:
Information provided by (Responsible Party):
Huma Riaz, Riphah International University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Postmenopausal Osteoporosis Postmenopausal Osteopenia Other: High Intensity Exercises Other: General Exercises Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This will be a Single factor, Pretest-Postest Control group Design with parallel assignment of patients into two groups.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Females participating in clinical trial will be kept blind with respect to their allocated exercise group. Assessor will be doing reporting for DEXA scan will also be kept blind about patient group.
Primary Purpose: Treatment
Official Title: Effects of High Intensity Multi-Modal Exercise Training on Bone Density and Functional Performance in Postmenopausal Women
Actual Study Start Date : November 1, 2020
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HIT-MMEX Group
In this group 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.
Other: High Intensity Exercises
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.

Active Comparator: Control Group
In this Group 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.
Other: General Exercises
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 Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04653350


Contacts
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Contact: Huma Riaz, Phd* 92 321 5242874 huma.riaz@riphah.edu.pk
Contact: Imran Amjad, Phd 03324390125 imran.amjad@riphah.edu.pk

Locations
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Pakistan
Rehab Center RCRAHS Potohar campus Recruiting
Rawalpindi, Punjab, Pakistan, 40100
Contact: Huma Riaz, PHD*    03215242874    huma.riaz@riphah.edu.pk   
Sponsors and Collaborators
Riphah International University
Investigators
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Principal Investigator: Huma Riaz, Phd* Riphah International University
Study Chair: Muhammad Naveed Babur, Phd Isra University islamabad
Publications:

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Responsible Party: Huma Riaz, Associate Professor, Riphah International University
ClinicalTrials.gov Identifier: NCT04653350    
Other Study ID Numbers: RiphahIU Huma Riaz
First Posted: December 4, 2020    Key Record Dates
Last Update Posted: December 7, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Osteoporosis, Postmenopausal
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases