High Intensity Multi-Modal Exercise Training in Postmenopausal Women

Not Applicable

Completed

• Conditions: Postmenopausal Osteoporosis; Postmenopausal Osteopenia
• Interventions: Other: High Intensity Exercises; Other: General Exercises

• Registration Number: NCT04653350
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2020-11-01
• Study First Submitted: 2020-11-26
• Study First Submitted QC: 2020-11-26
• Study First Posted: 2020-12-04
• Status Verified: 2022-06
• Primary Completion: 2022-06-10
• Study Completion: 2022-06-10
• Last Update Submitted: 2022-06-17
• Last Update Posted: 2022-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 58

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HIT-MMEX Group	High Intensity Exercises	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.
Control Group	General Exercises	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.

Primary Outcome Measures

Name	Time	Method
Femoral Neck BMD (FN BMD)	8 Months	Change from Baseline in Femoral Neck Bone Mineral Density measured by DEXA scan
Lumbar Spine BMD (LS BMD)	8 Months	Change from Baseline in Lumbar Spine Bone Mineral Density measured by DEXA scan

Secondary Outcome Measures

Name	Time	Method
30-second sit to stand test (Reps)	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
Berg balance scale	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.
Time up and Go test	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.
Dynamic Gait Index	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
1 RM for Trunk Extensors	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.
Functional Reach Test (FRT)	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.
1 RM for Leg Extensors	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.
Falls Efficacy Scale	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.

Trial Locations

Locations (2)

Rehab Center RCRAHS Potohar campus; 🇵🇰 Rawalpindi, Punjab, Pakistan

Behbud Association of Pakistan; 🇵🇰 Rawalpindi, Punjab, Pakistan