Postmenopausal OsteoporosisHIT-MMEXNCT04653350
High Intensity Multi-Modal Exercise Training in Postmenopausal Women
A study testing High Intensity Exercises and General Exercises in people with Postmenopausal Osteoporosis and Postmenopausal Osteopenia, run by Riphah International University at 2 sites in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Osteoporosis, Postmenopausal Osteopenia
- What is being tested?
- High Intensity Exercises and General Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 Nov 2020to 10 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Rehab Center RCRAHS Potohar campus
Rawalpindi, Punjab Province, 40100
Behbud Association of Pakistan
Rawalpindi, Punjab Province, 46000
About this study
Official title: Effects of High Intensity Multi-Modal Exercise Training on Bone Density and Functional Performance 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.
Read the 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.
- Being tested
- High Intensity Exercises, General Exercises
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity ExercisesOther
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 ExercisesOther
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
| Study group | Role | What they receive |
|---|---|---|
| HIT-MMEX Group | Experimental | 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. Receives: Other: High Intensity Exercises |
| Control Group | Active comparator | 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. Receives: Other: General Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Femoral Neck BMD (FN BMD)
Change from Baseline in Femoral Neck Bone Mineral Density measured by DEXA scan
Measured: 8 Months
Lumbar Spine BMD (LS BMD)
Change from Baseline in Lumbar Spine Bone Mineral Density measured by DEXA scan
Measured: 8 Months
Secondary outcomes (16)
1 RM for Leg Extensors
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.
Measured: 3 Months
1 RM for Leg Extensors
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.
Measured: 6 Months
1 RM for Trunk Extensors
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.
Measured: 3 Months
1 RM for Trunk Extensors
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.
Measured: 6 Months
30-second sit to stand test (Reps)
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
Measured: 3 Months
30-second sit to stand test (Reps)
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
Measured: 6 Months
Time up and Go test
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.
Measured: 3 Months
Time up and Go test
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.
Measured: 6 Months
Dynamic Gait Index
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
Measured: 3 Months
Dynamic Gait Index
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
Measured: 6 Months
Falls Efficacy Scale
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.
Measured: 3 Months
Falls Efficacy Scale
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.
Measured: 6 Months
Berg balance scale
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.
Measured: 3 Months
Berg balance scale
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.
Measured: 6 Months
Functional Reach Test (FRT)
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.
Measured: 3 Months
Functional Reach Test (FRT)
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.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start1 Nov 2020
- Primary completion10 Jun 2022
- Study completion10 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Postmenopausal OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a Single factor, Pretest-Postest Control group Design with parallel assignment of patients into two groups.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huma Riaz, Riphah International University
- Investigators
- Huma Riaz, Phd*, Principal investigator, Riphah International UniversityMuhammad Naveed Babur, Phd, Study chair, Isra University islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04653350
- Sponsor's protocol ID
- RiphahIU Huma Riaz
- Acronym
- HIT-MMEX
- Status last verified
- Jun 2022
- First submitted
- 26 Nov 2020
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gianoudis J, Bailey CA, Sanders KM, Nowson CA, Hill K, Ebeling PR, Daly RM. Osteo-cise: strong bones for life: protocol for a community-based randomised controlled trial of a multi-modal exercise and osteoporosis education program for older adults at risk of falls and fractures. BMC Musculoskelet Disord. 2012 May 28;13:78. doi: 10.1186/1471-2474-13-78.
PubMed 22640372Watson SL, Weeks BK, Weis LJ, Harding AT, Horan SA, Beck BR. High-Intensity Resistance and Impact Training Improves Bone Mineral Density and Physical Function in Postmenopausal Women With Osteopenia and Osteoporosis: The LIFTMOR Randomized Controlled Trial. J Bone Miner Res. 2018 Feb;33(2):211-220. doi: 10.1002/jbmr.3284. Epub 2017 Oct 4.
PubMed 28975661Watson S, Weeks B, Weis L, Harding A, Horan S, Beck B. High-Intensity Resistance and Impact Training Improves Bone Mineral Density and Physical Function in Postmenopausal Women With Osteopenia and Osteoporosis: The LIFTMOR Randomized Controlled Trial. J Bone Miner Res. 2019 Mar;34(3):572. doi: 10.1002/jbmr.3659. Epub 2019 Feb 25. No abstract available.
PubMed 30861219Watson SL, Weeks BK, Weis LJ, Horan SA, Beck BR. Heavy resistance training is safe and improves bone, function, and stature in postmenopausal women with low to very low bone mass: novel early findings from the LIFTMOR trial. Osteoporos Int. 2015 Dec;26(12):2889-94. doi: 10.1007/s00198-015-3263-2. Epub 2015 Aug 5.
PubMed 26243363Watson SL, Weeks BK, Weis LJ, Harding AT, Horan SA, Beck BR. High-intensity exercise did not cause vertebral fractures and improves thoracic kyphosis in postmenopausal women with low to very low bone mass: the LIFTMOR trial. Osteoporos Int. 2019 May;30(5):957-964. doi: 10.1007/s00198-018-04829-z. Epub 2019 Jan 5.
PubMed 30612163Marques EA, Mota J, Machado L, Sousa F, Coelho M, Moreira P, Carvalho J. Multicomponent training program with weight-bearing exercises elicits favorable bone density, muscle strength, and balance adaptations in older women. Calcif Tissue Int. 2011 Feb;88(2):117-29. doi: 10.1007/s00223-010-9437-1. Epub 2010 Nov 27.
PubMed 21113584Riaz H, Babur MN, Farooq A. Effects of high-intensity multi-modal exercise training (HIT-MMEX) on bone mineral density and muscle performance in postmenopausal women. A Pilot randomized controlled trial. J Pak Med Assoc. 2022 Oct;72(10):1904-1908. doi: 10.47391/JPMA.5394.
PubMed 36660974
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High Intensity Multi-Modal Exercise Training on Bone Density and Functional Performance in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT04653350
- Acronym / sponsor ID
- HIT-MMEX / RiphahIU Huma Riaz
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 10 Jun 2022 (actual)
- Study completion
- 10 Jun 2022 (actual)
- First posted
- 4 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This will be a Single factor, Pretest-Postest Control group Design with parallel assignment of patients into two groups.
| Arm | Type | Receives |
|---|---|---|
| HIT-MMEX Group | Experimental | Other: High Intensity ExercisesIn 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. |
| Control Group | Active comparator | Other: General ExercisesIn 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. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Intensity ExercisesSupervised 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 | HIT-MMEX Group |
| General ExercisesSupervised 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 | Control Group |
Primary outcome
Femoral Neck BMD (FN BMD)
Time frame: 8 Months
Change from Baseline in Femoral Neck Bone Mineral Density measured by DEXA scan
Lumbar Spine BMD (LS BMD)
Time frame: 8 Months
Change from Baseline in Lumbar Spine Bone Mineral Density measured by DEXA scan
16 secondary outcomes
1 RM for Leg Extensors
Time frame: 3 Months
1 RM for Leg Extensors
Time frame: 6 Months
1 RM for Trunk Extensors
Time frame: 3 Months
1 RM for Trunk Extensors
Time frame: 6 Months
30-second sit to stand test (Reps)
Time frame: 3 Months
30-second sit to stand test (Reps)
Time frame: 6 Months
Time up and Go test
Time frame: 3 Months
Time up and Go test
Time frame: 6 Months
Dynamic Gait Index
Time frame: 3 Months
Dynamic Gait Index
Time frame: 6 Months
Falls Efficacy Scale
Time frame: 3 Months
Falls Efficacy Scale
Time frame: 6 Months
Berg balance scale
Time frame: 3 Months
Berg balance scale
Time frame: 6 Months
Functional Reach Test (FRT)
Time frame: 3 Months
Functional Reach Test (FRT)
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Background: PubMed 22640372Gianoudis J, Bailey CA, Sanders KM, Nowson CA, Hill K, Ebeling PR, Daly RM. Osteo-cise: strong bones for life: protocol for a community-based randomised controlled trial of a multi-modal exercise and osteoporosis education program for older adults at risk of falls and fractures. BMC Musculoskelet Disord. 2012 May 28;13:78. doi: 10.1186/1471-2474-13-78.
- Background: PubMed 28975661Watson SL, Weeks BK, Weis LJ, Harding AT, Horan SA, Beck BR. High-Intensity Resistance and Impact Training Improves Bone Mineral Density and Physical Function in Postmenopausal Women With Osteopenia and Osteoporosis: The LIFTMOR Randomized Controlled Trial. J Bone Miner Res. 2018 Feb;33(2):211-220. doi: 10.1002/jbmr.3284. Epub 2017 Oct 4.
- Background: PubMed 30861219Watson S, Weeks B, Weis L, Harding A, Horan S, Beck B. High-Intensity Resistance and Impact Training Improves Bone Mineral Density and Physical Function in Postmenopausal Women With Osteopenia and Osteoporosis: The LIFTMOR Randomized Controlled Trial. J Bone Miner Res. 2019 Mar;34(3):572. doi: 10.1002/jbmr.3659. Epub 2019 Feb 25. No abstract available.
- Background: PubMed 26243363Watson SL, Weeks BK, Weis LJ, Horan SA, Beck BR. Heavy resistance training is safe and improves bone, function, and stature in postmenopausal women with low to very low bone mass: novel early findings from the LIFTMOR trial. Osteoporos Int. 2015 Dec;26(12):2889-94. doi: 10.1007/s00198-015-3263-2. Epub 2015 Aug 5.
- Background: PubMed 30612163Watson SL, Weeks BK, Weis LJ, Harding AT, Horan SA, Beck BR. High-intensity exercise did not cause vertebral fractures and improves thoracic kyphosis in postmenopausal women with low to very low bone mass: the LIFTMOR trial. Osteoporos Int. 2019 May;30(5):957-964. doi: 10.1007/s00198-018-04829-z. Epub 2019 Jan 5.
- Background: PubMed 21113584Marques EA, Mota J, Machado L, Sousa F, Coelho M, Moreira P, Carvalho J. Multicomponent training program with weight-bearing exercises elicits favorable bone density, muscle strength, and balance adaptations in older women. Calcif Tissue Int. 2011 Feb;88(2):117-29. doi: 10.1007/s00223-010-9437-1. Epub 2010 Nov 27.
- Derived from this study: PubMed 36660974Riaz H, Babur MN, Farooq A. Effects of high-intensity multi-modal exercise training (HIT-MMEX) on bone mineral density and muscle performance in postmenopausal women. A Pilot randomized controlled trial. J Pak Med Assoc. 2022 Oct;72(10):1904-1908. doi: 10.47391/JPMA.5394.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huma Riaz, Phd* principal investigator
Riphah International University
Muhammad Naveed Babur, Phd study chair
Isra University islamabad
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Exercises and General Exercises in people with Postmenopausal Osteoporosis and Postmenopausal Osteopenia, run by Riphah International University at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Femoral Neck BMD (FN BMD) (time frame: 8 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04653350, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2022.