Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05961371
Other study ID # REB22-1632
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2023
Est. completion date June 2025

Study information

Verified date November 2023
Source University of Calgary
Contact Charley Hasselaar
Phone 4032108518
Email cmhassel@ucalgary.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date June 2025
Est. primary completion date June 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 45 Years to 60 Years
Eligibility 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.

Study Design


Intervention

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

Locations

Country Name City State
Canada University of Calgary Calgary Alberta

Sponsors (1)

Lead Sponsor Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

References & Publications (8)

Finkelstein JS, Brockwell SE, Mehta V, Greendale GA, Sowers MR, Ettinger B, Lo JC, Johnston JM, Cauley JA, Danielson ME, Neer RM. Bone mineral density changes during the menopause transition in a multiethnic cohort of women. J Clin Endocrinol Metab. 2008 — View Citation

Harlow SD, Gass M, Hall JE, Lobo R, Maki P, Rebar RW, Sherman S, Sluss PM, de Villiers TJ; STRAW + 10 Collaborative Group. Executive summary of the Stages of Reproductive Aging Workshop + 10: addressing the unfinished agenda of staging reproductive aging. J Clin Endocrinol Metab. 2012 Apr;97(4):1159-68. doi: 10.1210/jc.2011-3362. Epub 2012 Feb 16. — View Citation

Howe TE, Shea B, Dawson LJ, Downie F, Murray A, Ross C, Harbour RT, Caldwell LM, Creed G. Exercise for preventing and treating osteoporosis in postmenopausal women. Cochrane Database Syst Rev. 2011 Jul 6;(7):CD000333. doi: 10.1002/14651858.CD000333.pub2. — View Citation

Kistler-Fischbacher M, Weeks BK, Beck BR. The effect of exercise intensity on bone in postmenopausal women (part 2): A meta-analysis. Bone. 2021 Feb;143:115697. doi: 10.1016/j.bone.2020.115697. Epub 2020 Dec 24. — View Citation

Lewis M, Bromley K, Sutton CJ, McCray G, Myers HL, Lancaster GA. Determining sample size for progression criteria for pragmatic pilot RCTs: the hypothesis test strikes back! Pilot Feasibility Stud. 2021 Feb 3;7(1):40. doi: 10.1186/s40814-021-00770-x. — View Citation

Watson S, Weeks B, Weis L, Harding A, Horan S, Beck B. High-Intensity Resistance and Impact Training Improves Bone Mineral Density and Physical Function in Postmenopausal Women With Osteopenia and Osteoporosis: The LIFTMOR Randomized Controlled Trial. J B — View Citation

Watson SL, Weeks BK, Weis LJ, Horan SA, Beck BR. Heavy resistance training is safe and improves bone, function, and stature in postmenopausal women with low to very low bone mass: novel early findings from the LIFTMOR trial. Osteoporos Int. 2015 Dec;26(12 — View Citation

Weeks BK, Beck BR. The BPAQ: a bone-specific physical activity assessment instrument. Osteoporos Int. 2008 Nov;19(11):1567-77. doi: 10.1007/s00198-008-0606-2. Epub 2008 Apr 15. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility - Recruitment Recruitment rates - number of participants recruited per month and number of eligible participants who consented. Over 9 months
Primary Feasibility - Adherence Protocol adherence (number of exercise sessions participants attend) will be expressed as a percent. Over 9 months
Primary Feasibility - Attrition Attrition (number of randomized participants with valid outcome data) will be expressed as a percent. Over 9 months
Secondary Volumetric bone mineral density (BMD) 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. Baseline and 9 months
Secondary Bone microarchitecture HR-pQCT will assess trabecular thickness and separation and cortical bone thickness in mm at the distal tibia and radius. Baseline and 9 months
Secondary Bone strength Finite element analysis will be applied to HR-pQCT images at the distal tibia and radius to estimate bone strength (failure load) in N. Baseline and 9 months
Secondary areal bone mineral density 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. Baseline and 9 months
Secondary Muscle strength 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. Baseline and 9 months
Secondary Balance The four-square-step test assesses dynamic balance. Baseline and 9 months
Secondary Aerobic Fitness The 6-minute walk test assesses aerobic fitness Baseline and 9 months
Secondary Estrogen concentration A blood sample will measure plasma estradiol in pmol/L Baseline and 9 months
Secondary Follicle stimulating hormone concentration A blood sample will measure plasma follicle stimulating hormone (FSH) in IU/L Baseline and 9 months
Secondary Vitamin D concentration A blood sample will measure plasma 25-hydroxyvitamin D in nmol/L Baseline and 9 months
Secondary Calcium concentration A blood sample will measure plasma calcium in mmol/L Baseline and 9 months
Secondary Creatinine concentration A blood sample will measure plasma creatinine in umol/L Baseline and 9 months
Secondary Biomarker of bone resorption A blood sample will measure plasma c-telopeptide (CTx) in ng/L Baseline and 9 months
Secondary Biomarker of bone formation A blood sample will measure plasma procollagen 1 intact N-terminal propeptide (P1NP) in ug/L Baseline and 9 months
Secondary Physical activity Physical activity will be assessed by wearing an accelerometer for 7 days to assess moderate to vigorous physical activity in minutes per day. Baseline and 9 months
Secondary Menopausal quality of life 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 Baseline and 9 months
Secondary Menopausal symptoms 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 9 months
Secondary Body mass Body mass in kg Baseline and 9 months
Secondary Height Height in cm Baseline and 9 months
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06287502 - Efficacy of Structured Exercise-Nutritional Intervention on Sarcopenia in Patients With Osteoporosis N/A
Completed NCT03822078 - Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Denosumab (AMG 162) in Japanese Postmenopausal Women Phase 1
Recruiting NCT05845021 - Surgeon-Initiated Bone Health Referral Pathway in Patients Undergoing Lower Extremity Arthroplasty N/A
Completed NCT00092066 - A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227) Phase 3
Recruiting NCT04754711 - Interest of Nutritional Care of Children With Sickle Cell Disease on Bone Mineral Density and Body Composition N/A
Completed NCT04736693 - Replication of the HORIZON Pivotal Fracture Trial in Healthcare Claims Data
Not yet recruiting NCT06431867 - Primary Care Management of Osteoporosis in Older Women
Completed NCT02922478 - Role of Comorbidities in Chronic Heart Failure Study
Recruiting NCT02616627 - Association Between DXA Results and the Complications, Clinical Courses and Outcomes in Chronic Dialysis Patients
Recruiting NCT02635022 - Fragility Fracture Liaison Service and Anti-osteoporosis Medication Monitoring Service Study
Active, not recruiting NCT02617303 - Prevention of Falls and Its Consequences in Elderly People N/A
Completed NCT02566655 - Clinical Trial of Intravenous Infusion of Fucosylated Bone Marrow Mesenchyme Cells in Patients With Osteoporosis Phase 1
Completed NCT03420716 - Symbiotic Yogurt, Calcium Absorption and Bone Health in Young Adult Women N/A
Not yet recruiting NCT02223572 - Secondary Fracture Prevention in Patients Who Suffered From Osteoporotic Fracture N/A
Completed NCT02559648 - Denosumab vs Placebo in Patients With Thalassemia Major and Osteoporosis Phase 2
Not yet recruiting NCT01854086 - Compliance and Persistence With Osteoporosis Treatment and Attitude Towards Future Therapy Among Post-menopausal Israeli Women During Drug Treatment or Drug Holiday N/A
Unknown status NCT01913834 - Nasally and sc Administered Teriparatide in Healthy Volunteers Phase 1
Completed NCT02003716 - DeFRA Questionnaire as an Anamnestic Form N/A
Completed NCT01694784 - Understanding and Discouraging Overuse of Potentially Harmful Screening Tests N/A
Completed NCT01757340 - Calorie Restriction With Leucine Supplementation N/A