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Active, Not Recruiting

NCT Number: NCT05961371

Strength Training for Osteoporosis Prevention During Early Menopause

The goal of this clinical pilot trial is to learn about the feasibility of a high-intensity resistance training intervention in peri- and early menopausal females. The main question it aims to answer are:

-Is a 9-month resistance training intervention feasible (e.g., recruitment rates, protocol adherence, attrition)

Secondary aims include examining changes in bone health, muscle strength, and menopausal symptoms.

Participants will participate in a 9-month progressive, supervised, resistance training intervention. Researchers will compare secondary outcomes between the exercise group and a wait-list control group.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Bone Loss Behavior Bone Diseases Bone Diseases, Metabolic Bone Loss, Age-related Metabolic Diseases Motor Activity Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis

Age range

45 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

About this study

The STOP-EM trial will examine a 9-month supervised, progressive, resistance training program in peri- and early menopausal females. Primary outcomes include recruitment rates, protocol adherence, and attrition. A waitlist control group will allow us to examine the effect of the exercise program on bone density, structure, and strength, muscle strength, and menopausal symptoms. Participants will be randomized to the exercise or control group. The exercise group will attend twice weekly, in-person, supervised, progressive resistance training and build up to 80-90% of estimated 1 repetition maximum (1RM). The study will take place at the University of Calgary. Findings will be used to decide whether to continue to the definitive trial.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 45-60 years old.
  • Menopause status of peri- or early menopausal: stages -2 or -1 of the stages for reproductive aging 10+ staging system or are within 5 years of their last known menses.

Exclusion criteria

  • Females who are pregnant or planning pregnancy within the next year.
  • Orthopaedic conditions that may be made worse with exercise.
  • Has low back pain, hypertension, lipidemia, diabetes, or cardiovascular disease.
  • Has a history of metabolic bone disease.
  • Has had an osteoporotic fracture within the last 5 years.
  • Had previous treatment with osteoporosis pharmacotherapy.
  • Has active glucocorticoid use.
  • Is currently participating in progressive resistance training or has in the previous 6 months.
  • Has low serum vitamin D (25(OH)D) < 30 nmol/L or serum calcium <2.10 mmol/L.

Treatment and study plan

Resistance training

Other

Twice weekly resistance training progressing to 5 sets of 5 repetitions of 80-90% of one repetition maximum.

Primary outcomes

  1. Feasibility - Recruitment

    Time frame: Over 9 months

    Recruitment rates - number of participants recruited per month and number of eligible participants who consented.

  2. Feasibility - Adherence

    Time frame: Over 9 months

    Protocol adherence (number of exercise sessions participants attend) will be expressed as a percent.

  3. Feasibility - Attrition

    Time frame: Over 9 months

    Attrition (number of randomized participants with valid outcome data) will be expressed as a percent.

Secondary outcomes

  1. Volumetric bone mineral density (BMD)

    Time frame: Baseline and 9 months

    High-resolution peripheral quantitative computed tomography (HR-pQCT) will assess total, trabecular, and cortical BMD in mg/cm^3 at the distal tibia and radius.

  2. Bone microarchitecture

    Time frame: Baseline and 9 months

    HR-pQCT will assess trabecular thickness and separation and cortical bone thickness in mm at the distal tibia and radius.

  3. Bone strength

    Time frame: Baseline and 9 months

    Finite element analysis will be applied to HR-pQCT images at the distal tibia and radius to estimate bone strength (failure load) in N.

  4. areal bone mineral density

    Time frame: Baseline and 9 months

    Dual X-ray absorptiometry (DXA) will measure areal bone mineral density (aBMD) in mg/cm^2 for the left hip (total hip and femoral neck), lumbar spine, and whole body.

  5. Muscle strength

    Time frame: Baseline and 9 months

    Muscle strength testing will include max voluntary contractions of the knee extensors using an isometric dynamometer. Hand grip strength will be measured using a handgrip dynamometer.

  6. Balance

    Time frame: Baseline and 9 months

    The four-square-step test assesses dynamic balance.

  7. Aerobic Fitness

    Time frame: Baseline and 9 months

    The 6-minute walk test assesses aerobic fitness

  8. Estrogen concentration

    Time frame: Baseline and 9 months

    A blood sample will measure plasma estradiol in pmol/L

  9. Follicle stimulating hormone concentration

    Time frame: Baseline and 9 months

    A blood sample will measure plasma follicle stimulating hormone (FSH) in IU/L

  10. Vitamin D concentration

    Time frame: Baseline and 9 months

    A blood sample will measure plasma 25-hydroxyvitamin D in nmol/L

  11. Calcium concentration

    Time frame: Baseline and 9 months

    A blood sample will measure plasma calcium in mmol/L

  12. Creatinine concentration

    Time frame: Baseline and 9 months

    A blood sample will measure plasma creatinine in umol/L

  13. Biomarker of bone resorption

    Time frame: Baseline and 9 months

    A blood sample will measure plasma c-telopeptide (CTx) in ng/L

  14. Biomarker of bone formation

    Time frame: Baseline and 9 months

    A blood sample will measure plasma procollagen 1 intact N-terminal propeptide (P1NP) in ug/L

  15. Physical activity

    Time frame: Baseline and 9 months

    Physical activity will be assessed by wearing an accelerometer for 7 days to assess moderate to vigorous physical activity in minutes per day.

  16. Menopausal quality of life

    Time frame: Baseline and 9 months

    Menopausal symptoms will be evaluated through the menopause-specific quality of life questionnaire with a minimum score of 0 and maximum score of 174 and a higher score indicating poorer outcomes

  17. Menopausal symptoms

    Time frame: 9 months

    Menopausal symptoms will be evaluated through the menopause symptoms treatment satisfaction questionnaire with a minimum score of 0 and maximum score of 40 and a higher score indicating poorer outcomes

  18. Body mass

    Time frame: Baseline and 9 months

    Body mass in kg

  19. Height

    Time frame: Baseline and 9 months

    Height in cm

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Acronym: STOP-EM

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 27, 2023
Registry last updated
Dec 5, 2024

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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