Strength Training for Osteoporosis Prevention During Early Menopause

NCT05961371 | Active Not Recruiting DMC

• 1 other identifier: REB22-1632
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Loss; Bone Loss, Age-related; Osteoporosis; Musculoskeletal Diseases

Keywords

Exercise; Resistance Training; Strength Training

Outcome Measures

Primary Outcomes (3)

• Feasibility - Recruitment

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

  Over 9 months

• Feasibility - Adherence

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

  Over 9 months

• Feasibility - Attrition

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

  Over 9 months

Secondary Outcomes (19)

• Volumetric bone mineral density (BMD)

  Baseline and 9 months

• Bone microarchitecture

  Baseline and 9 months

• Bone strength

  Baseline and 9 months

• areal bone mineral density

  Baseline and 9 months

• Muscle strength

  Baseline and 9 months

Study Arms (2)

Exercise

EXPERIMENTAL

In-person, supervised resistance training program

Other: Resistance Training

Control

NO INTERVENTION

Waitlist control group. Will be offered the exercise program following a 9-month wait.

Interventions

Resistance Training OTHER

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

Exercise

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

Related Publications (9)

• 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 Bone Miner Res. 2019 Mar;34(3):572. doi: 10.1002/jbmr.3659. Epub 2019 Feb 25. No abstract available.

  PMID: 30861219 BACKGROUND

• 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.

  PMID: 33357834 BACKGROUND

• 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.

  PMID: 33536076 BACKGROUND

• 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 Mar;93(3):861-8. doi: 10.1210/jc.2007-1876. Epub 2007 Dec 26.

  PMID: 18160467 BACKGROUND

• 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;2011(7):CD000333. doi: 10.1002/14651858.CD000333.pub2.

  PMID: 21735380 BACKGROUND

• 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):2889-94. doi: 10.1007/s00198-015-3263-2. Epub 2015 Aug 5.

  PMID: 26243363 BACKGROUND

• 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.

  PMID: 18414964 BACKGROUND

• 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.

  PMID: 22344196 BACKGROUND

• Alexander CJ, Kaluta L, Whitman PW, Billington EO, Burt LA, Gabel L. Strength training for osteoporosis prevention during early menopause (STOP-EM): a pilot study protocol for a single centre randomised waitlisted control trial in Canada. BMJ Open. 2025 Feb 5;15(2):e093711. doi: 10.1136/bmjopen-2024-093711.

  PMID: 39909519 DERIVED

MeSH Terms

Conditions

Bone Diseases, Metabolic; Osteoporosis; Musculoskeletal Diseases; Motor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Bone Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Leigh Gabel, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators and outcome assessors will be masked to the group allocation of participants.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be randomized 1:1 to the exercise or waitlist control group.

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 27, 2023
• Study Start: November 1, 2023
• Primary Completion: February 1, 2025
• Study Completion: June 1, 2025
• Last Updated: December 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)