Strength Training for Osteoporosis Prevention During Early Menopause

Last updated: December 3, 2024
Sponsor: University of Calgary
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Osteoporosis

Osteopenia

Musculoskeletal Diseases

Treatment

Resistance Training

Clinical Study ID

NCT05961371
REB22-1632
  • Ages 45-60
  • Female
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 45-60 years old.

  • Menopause status of peri- or early menopausal: stages -2 or -1 of the stages forreproductive aging 10+ staging system or are within 5 years of their last knownmenses.

Exclusion

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.

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Resistance Training
Phase:
Study Start date:
November 01, 2023
Estimated Completion Date:
June 30, 2025

Study Description

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.

Connect with a study center

  • University of Calgary

    Calgary, Alberta T2N 1N4
    Canada

    Site Not Available

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