Strength Training for Osteoporosis Prevention During Early Menopause (STOP-EM)

University of Calgary

Status

Active, not recruiting

Conditions

Osteoporosis

Bone Loss, Age-related

Musculoskeletal Diseases

Bone Loss

Treatments

Other: Resistance Training

Study type

Interventional

Funder types

Other

Identifiers

NCT05961371

REB22-1632

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

Female

Ages

45 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.