Finding the Optimal Resistance Training Intensity For Your Bones

NCT05541432 | Active Not Recruiting

• 1 other identifier: 41337
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 3

Brief Summary

Osteoporosis is a bone disease that can result in fractures, disability and an increased risk of premature death. Exercise is recommended for fall and fracture prevention, but health care professionals often recommend walking or lower intensity community exercise classes, which may not be effective for building bone. Further, individuals with osteoporosis are often told to avoid lifting or moving in certain ways, which creates fear and activity avoidance. Conversely, research suggests that to stimulate bone, you need higher loads on bone, with either higher intensity resistance training or impact exercise - the types of things people with low bone mass are told to avoid. Our study will examine different types of exercise intensity and how they translate to building bone in people with low bone mineral density (BMD).

Conditions

Osteoporosis; Osteopenia

Keywords

Bone fracture; Strength training; Exercise; Bone mineral density; Muscle strength; Resistance training

Outcome Measures

Primary Outcomes (1)

• Lumbar Spine bone mineral density (BMD)

  Lumbar spine (L1-L4) bone mineral density measured via dual-energy X-ray Absorptiometry (DXA) scan.

  Baseline and 12 months

Secondary Outcomes (30)

• Fractures

  Over 12 months

• Rate of falls per person per year

  Over 12 months

• Number of people who experience one or more falls

  Over 12 months

• Bone-free lean mass

  Baseline and 12 months

• Appendicular lean mass

  Baseline and 12 months

Other Outcomes (1)

• Dietary Intake

  Baseline, 6 months, and 12 months

Study Arms (3)

Home exercise

ACTIVE COMPARATOR

Home exercise program, with biweekly group virtual education and exercise classes.

Other: Home exercise

Supervised strength training (group 1)

EXPERIMENTAL

In-person, supervised muscle strengthening exercises twice weekly at a specific intensity.

Other: Supervised strength training (group 1)

Supervised strength training (group 2)

EXPERIMENTAL

In-person, supervised muscle strengthening exercises twice weekly at a specific intensity.

Other: Supervised strength training (group 2)

Interventions

Supervised strength training (group 1) OTHER

Participants in this arm will complete twice weekly resistance training. They will focus on form initially, and then be progressed to 3 sets of 10-12 repetitions at an intensity of \~70% of estimated 1 repetition maximum.

Supervised strength training (group 1)

Supervised strength training (group 2) OTHER

Participants in this arm will complete twice weekly resistance training. They will focus on form initially, and then be progressed to 3 sets of \~4-6 repetitions at an intensity of 85% of estimated one repetition maximum, with a warm-up set of 8 repetitions at their estimated 70% estimated one repetition maximum to attempt to match the volume performed in the other resistance training group.

Supervised strength training (group 2)

Home exercise OTHER

Participants in this arm will complete twice-weekly upper and lower body exercises at home, focused on posture and balance. Participants will meet 1:1 with an exercise physiologist who will select and prescribe exercises. Participants will also be invited to attend twice monthly virtual exercise and education sessions.

Home exercise

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 50 or over
• Has received 2 vaccines for COVID-19
• Has femoral neck, total hip, or lumbar spine BMD T-score of ≤ -1, OR has been or have a FRAX probability of fracture of greater than or equal to 20% for major osteoporotic fracture or 3% or greater for hip fracture.\*
• Individuals at high risk of fracture (i.e., risk in next 10 years is \>20% according to FRAX) should be offered medication for osteoporosis. We will only include individuals at high risk of fracture who have declined medication or who had been on osteoporosis medication and decided to cease taking it in the appropriate timeline (as outlined by PI's and Physician).
• Willing to participate in 2x weekly exercise sessions
• Self-reported as postmenopausal for ≥ 2 years, OR postmenopausal stats confirmed via blood test (female participants only)

You may not qualify if:

• Is unable to communicate in English
• Has conditions affecting bone health
• Takes or has taken medications affecting bone in the last 12 months or longer (as determined by the research team)
• Has had a clinical or symptomatic spine fracture in the last 12 months, or a lower/upper limb fracture in the last 6 months
• Has had a joint replacement in the last 6 months
• Is receiving palliative care
• Has major surgery planned in the next 12 months
• Has had cancer within the last 2 years (excluding non-melanoma skin cancer)
• Has planned travel time of greater than 6 weeks
• Has been diagnosed with dementia
• Is already participating in moderate- or high-intensity progressive resistance training ≥ twice weekly
• Weighs over 450 lbs
• Has contraindications to resistance training

Sponsors & Collaborators

• University of Waterloo: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• University of Saskatchewan: collaborator
• University Health Network, Toronto: collaborator

Study Sites (3)

University of Waterloo

Waterloo, Ontario, Canada

Location

University of Toronto

Markham, Canada

Location

University of Saskatchewan

Saskatoon, Canada

Location

Related Publications (14)

• Cauley JA, Thompson DE, Ensrud KC, Scott JC, Black D. Risk of mortality following clinical fractures. Osteoporos Int. 2000;11(7):556-61. doi: 10.1007/s001980070075.

  PMID: 11069188 BACKGROUND

• Lindsay R, Silverman SL, Cooper C, Hanley DA, Barton I, Broy SB, Licata A, Benhamou L, Geusens P, Flowers K, Stracke H, Seeman E. Risk of new vertebral fracture in the year following a fracture. JAMA. 2001 Jan 17;285(3):320-3. doi: 10.1001/jama.285.3.320.

  PMID: 11176842 BACKGROUND

• Ioannidis G, Papaioannou A, Hopman WM, Akhtar-Danesh N, Anastassiades T, Pickard L, Kennedy CC, Prior JC, Olszynski WP, Davison KS, Goltzman D, Thabane L, Gafni A, Papadimitropoulos EA, Brown JP, Josse RG, Hanley DA, Adachi JD. Relation between fractures and mortality: results from the Canadian Multicentre Osteoporosis Study. CMAJ. 2009 Sep 1;181(5):265-71. doi: 10.1503/cmaj.081720. Epub 2009 Aug 4.

  PMID: 19654194 BACKGROUND

• Hopkins RB, Burke N, Von Keyserlingk C, Leslie WD, Morin SN, Adachi JD, Papaioannou A, Bessette L, Brown JP, Pericleous L, Tarride J. The current economic burden of illness of osteoporosis in Canada. Osteoporos Int. 2016 Oct;27(10):3023-32. doi: 10.1007/s00198-016-3631-6. Epub 2016 May 11.

  PMID: 27166680 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

• El-Khoury F, Cassou B, Charles MA, Dargent-Molina P. The effect of fall prevention exercise programmes on fall induced injuries in community dwelling older adults: systematic review and meta-analysis of randomised controlled trials. BMJ. 2013 Oct 29;347:f6234. doi: 10.1136/bmj.f6234.

  PMID: 24169944 BACKGROUND

• Gillespie LD, Robertson MC, Gillespie WJ, Sherrington C, Gates S, Clemson LM, Lamb SE. Interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD007146. doi: 10.1002/14651858.CD007146.pub3.

  PMID: 22972103 BACKGROUND

• Sherrington C, Tiedemann A, Fairhall N, Close JC, Lord SR. Exercise to prevent falls in older adults: an updated meta-analysis and best practice recommendations. N S W Public Health Bull. 2011 Jun;22(3-4):78-83. doi: 10.1071/NB10056.

  PMID: 21632004 BACKGROUND

• Tricco AC, Thomas SM, Veroniki AA, Hamid JS, Cogo E, Strifler L, Khan PA, Robson R, Sibley KM, MacDonald H, Riva JJ, Thavorn K, Wilson C, Holroyd-Leduc J, Kerr GD, Feldman F, Majumdar SR, Jaglal SB, Hui W, Straus SE. Comparisons of Interventions for Preventing Falls in Older Adults: A Systematic Review and Meta-analysis. JAMA. 2017 Nov 7;318(17):1687-1699. doi: 10.1001/jama.2017.15006.

  PMID: 29114830 BACKGROUND

• Duckham RL, Masud T, Taylor R, Kendrick D, Carpenter H, Iliffe S, Morris R, Gage H, Skelton DA, Dinan-Young S, Brooke-Wavell K. Randomised controlled trial of the effectiveness of community group and home-based falls prevention exercise programmes on bone health in older people: the ProAct65+ bone study. Age Ageing. 2015 Jul;44(4):573-9. doi: 10.1093/ageing/afv055. Epub 2015 Apr 23.

  PMID: 25906791 BACKGROUND

• Nikander R, Gagnon C, Dunstan DW, Magliano DJ, Ebeling PR, Lu ZX, Zimmet PZ, Shaw JE, Daly RM. Frequent walking, but not total physical activity, is associated with increased fracture incidence: a 5-year follow-up of an Australian population-based prospective study (AusDiab). J Bone Miner Res. 2011 Jul;26(7):1638-47. doi: 10.1002/jbmr.363.

  PMID: 21328475 BACKGROUND

• Rikkonen T, Salovaara K, Sirola J, Karkkainen M, Tuppurainen M, Jurvelin J, Honkanen R, Alhava E, Kroger H. Physical activity slows femoral bone loss but promotes wrist fractures in postmenopausal women: a 15-year follow-up of the OSTPRE study. J Bone Miner Res. 2010 Nov;25(11):2332-40. doi: 10.1002/jbmr.143.

  PMID: 20533310 BACKGROUND

• Sherrington C, Fairhall NJ, Wallbank GK, Tiedemann A, Michaleff ZA, Howard K, Clemson L, Hopewell S, Lamb SE. Exercise for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2019 Jan 31;1(1):CD012424. doi: 10.1002/14651858.CD012424.pub2.

  PMID: 30703272 BACKGROUND

• Costa AG, Wyman A, Siris ES, Watts NB, Silverman S, Saag KG, Roux C, Rossini M, Pfeilschifter J, Nieves JW, Netelenbos JC, March L, LaCroix AZ, Hooven FH, Greenspan SL, Gehlbach SH, Diez-Perez A, Cooper C, Compston JE, Chapurlat RD, Boonen S, Anderson FA Jr, Adachi JD, Adami S. When, where and how osteoporosis-associated fractures occur: an analysis from the Global Longitudinal Study of Osteoporosis in Women (GLOW). PLoS One. 2013 Dec 11;8(12):e83306. doi: 10.1371/journal.pone.0083306. eCollection 2013.

  PMID: 24349484 BACKGROUND

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Wounds and Injuries; Behavior

Study Officials

• Lora Giangregorio, PhD

  University of Waterloo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators and outcome assessors will be masked to the group allocation of participants. Participants will be masked to the hypothesis of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized in a 1:1:1 ratio to one of three arms. Participants will perform exercise or control activities twice weekly for 12 months. Not all participants will start and end at the same time.

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: September 15, 2022
• Study Start: September 13, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 30, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)