Bone Loss, Bone Loss, Age-related, Musculoskeletal Diseases, Osteoporosis
Conditions
Keywords
Exercise, Resistance Training, Strength Training
Brief 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.
Detailed 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.
Interventions
OTHERResistance Training
Twice weekly resistance training progressing to 5 sets of 5 repetitions of 80-90% of one repetition maximum.
Sponsors
University of Calgary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Investigators and outcome assessors will be masked to the group allocation of participants.
Intervention model description
Participants will be randomized 1:1 to the exercise or waitlist control group.
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility - Recruitment | Over 9 months | Recruitment rates - number of participants recruited per month and number of eligible participants who consented. |
| Feasibility - Adherence | Over 9 months | Protocol adherence (number of exercise sessions participants attend) will be expressed as a percent. |
| Feasibility - Attrition | Over 9 months | Attrition (number of randomized participants with valid outcome data) will be expressed as a percent. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| areal bone mineral density | 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. |
| Muscle strength | 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. |
| Balance | Baseline and 9 months | The four-square-step test assesses dynamic balance. |
| Aerobic Fitness | Baseline and 9 months | The 6-minute walk test assesses aerobic fitness |
| Estrogen concentration | Baseline and 9 months | A blood sample will measure plasma estradiol in pmol/L |
| Follicle stimulating hormone concentration | Baseline and 9 months | A blood sample will measure plasma follicle stimulating hormone (FSH) in IU/L |
| Vitamin D concentration | Baseline and 9 months | A blood sample will measure plasma 25-hydroxyvitamin D in nmol/L |
| Calcium concentration | Baseline and 9 months | A blood sample will measure plasma calcium in mmol/L |
| Volumetric bone mineral density (BMD) | 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. |
| Biomarker of bone resorption | Baseline and 9 months | A blood sample will measure plasma c-telopeptide (CTx) in ng/L |
| Biomarker of bone formation | Baseline and 9 months | A blood sample will measure plasma procollagen 1 intact N-terminal propeptide (P1NP) in ug/L |
| Physical activity | 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. |
| Menopausal quality of life | 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 |
| Menopausal symptoms | 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 |
| Body mass | Baseline and 9 months | Body mass in kg |
| Height | Baseline and 9 months | Height in cm |
| Creatinine concentration | Baseline and 9 months | A blood sample will measure plasma creatinine in umol/L |
| Bone microarchitecture | Baseline and 9 months | HR-pQCT will assess trabecular thickness and separation and cortical bone thickness in mm at the distal tibia and radius. |
| Bone strength | 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. |
Countries
Canada
Outcome results
None listed