Strength Training Intensity for Osteoporosis

Recruiting at 2 trial locations

Overseen By Dave Varandas, BSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Waterloo

Must not be taking: Bone medications

Disqualifiers: Cancer, Dementia, Surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 104

Duration: 52 weeks

324 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

The trial requires that participants have not taken medications affecting bone health in the last 12 months. If you are currently on such medications, you may need to stop taking them to participate.

What data supports the effectiveness of the treatment Strength Training Intensity for Osteoporosis?

Research shows that high-load resistance training and power-based resistance training can improve bone mineral density (BMD) and reduce fall risk in postmenopausal women with osteoporosis. Additionally, maximal strength training has been found to enhance skeletal health by increasing bone mineral content and stimulating bone formation. ^{1 2 3 4 5}

Is strength training generally safe for humans?

Strength training is generally safe for humans and can help prevent muscle loss and injuries from falls. However, it's important to use proper techniques to avoid injuries, as outlined in protocols for safe lifting. ^{6 7 8 9 10}

How does supervised strength training differ from other treatments for osteoporosis?

Supervised strength training is unique because it involves high-intensity exercises specifically designed to improve bone density and muscle strength, which are crucial for reducing fracture risk in osteoporosis. Unlike other treatments that may focus on medication, this approach uses physical activity to directly target bone health and muscle function. ^{1 11 12 13 14}

Research Team

Lora Giangregorio, PhD

Principal Investigator

University of Waterloo

Eligibility Criteria

This trial is for individuals over 50 with low bone density or high fracture risk who have declined osteoporosis medication. Participants must be postmenopausal, willing to exercise twice weekly, and fully vaccinated against COVID-19. Those already doing similar training or with conditions affecting bone health cannot join.

Inclusion Criteria

I am a woman who has been postmenopausal for 2 years or more, or this has been confirmed by a blood test.

Willing to participate in 2x weekly exercise sessions

I am at high risk for bone fractures and have chosen not to take or stopped taking osteoporosis medication.

Exclusion Criteria

I have a condition that affects my bone health.

I cannot communicate in English.

I have had cancer other than non-melanoma skin cancer in the last 2 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in supervised twice-weekly progressive resistance training at moderate or high intensity, or a home posture and balance exercise program for one year

52 weeks

104 visits (in-person for supervised groups), biweekly virtual classes for home exercise group

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Home exercise
• Supervised strength training (group 1)
• Supervised strength training (group 2)

Trial Overview The study tests the effects of different exercise intensities on bone strength in people at risk for fractures due to low bone mineral density. It compares supervised strength training at two intensity levels versus home exercises.

Participant Groups

Group I: Supervised strength training (group 2) Experimental Treatment 1 Intervention

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

Group II: Supervised strength training (group 1) Experimental Treatment 1 Intervention

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

Group III: Home exercise Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Waterloo

Lead Sponsor

Trials

132

Recruited

221,000+

University of Saskatchewan

Collaborator

Trials

261

Recruited

156,000+

University Health Network, Toronto

Collaborator

Trials

1,555

Recruited

526,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Findings from Research

High-load resistance training (HLRT) significantly increases bone mineral density (BMD) in patients with osteoporosis and osteopenia, particularly in the lumbar spine, as shown by a meta-analysis of nine randomized controlled trials involving 495 patients.

While HLRT is effective for improving BMD, the study noted high heterogeneity and publication bias, indicating the need for further research with lower risk of bias to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of high-load resistance training on bone mineral density in osteoporosis and osteopenia: a meta-analysis. Kitsuda, Y., Wada, T., Noma, H., et al.[2021]

The study evaluates the effectiveness of a 12-month exercise program for women with post-menopausal osteoporosis, comparing individual home training (IHT) to gym group training (GGT) in a randomized trial involving sedentary patients.

The primary outcome is the improvement in quality of life, measured by the Short Osteoporosis Quality of Life Questionnaire, which will help determine the best exercise setting for enhancing physical activity in osteoporotic women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Clinical Trial to Evaluate the Efficacy and Safety of the ACTLIFE Exercise Program for Women with Post-menopausal Osteoporosis: Study Protocol. Bragonzoni, L., Barone, G., Benvenuti, F., et al.[2020]

A 12-month power-based resistance training program significantly improved bone mineral density (BMD) in a 70-year-old postmenopausal woman with osteoporosis, with increases of 24% in the lumbar spine and 29% in the femoral neck.

The training also reduced her fall risk, as indicated by a seven-point improvement in the Dynamic Gait Index, allowing her to be classified as a 'safe ambulator' after the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Power training improves bone mineral density and fall risk for a postmenopausal woman with a history of osteoporosis and increased risk of falling: A case report. Aquino, M., DiMenna, FJ., Petrizzo, J., et al.[2021]

A 12-week program of maximal strength training (MST) using squat exercises significantly improved strength measures (1-repetition maximum and rate of force development) in postmenopausal women with osteoporosis or osteopenia, indicating enhanced skeletal health.

The training also led to increases in bone mineral content at the lumbar spine and femoral neck, suggesting that MST can be an effective intervention for improving bone density and overall skeletal properties in patients with low bone mass.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maximal strength training in postmenopausal women with osteoporosis or osteopenia. Mosti, MP., Kaehler, N., Stunes, AK., et al.[2016]

In a study of 59 postmenopausal women with osteopenia or osteoporosis, a 12-month weight training program showed a slight increase in bone mineral density (BMD) in the lumbar spine by 1.17%, while the control group experienced a decrease of 2.26%.

Although the weight training did not lead to significant improvements in BMD, it highlighted the importance of exercise in maintaining bone health compared to no exercise, suggesting that such programs may help prevent further bone loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of specific exercise training on bone mineral density in women with postmenopausal osteopenia or osteoporosis. de Matos, O., Lopes da Silva, DJ., Martinez de Oliveira, J., et al.[2009]

The article highlights the need for physicians to better understand the various forms of weightlifting, including powerlifting, Olympic lifting, weight training, and bodybuilding, to address the specific medical and physiological issues associated with these sports.

It also reviews important topics such as age restrictions for lifters, the effects of drug use, potential strength gains, hypertrophy, and common injuries, emphasizing the unique health considerations for weightlifters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weightlifting, weight training and injuries. Basford, JR.[2022]

High-intensity resistance training significantly increases bone mineral density (BMD) in the lumbar spine and whole body, as shown in a study of 10 male powerlifters compared to 11 control subjects.

There is a strong correlation between lumbar spine BMD and powerlifting performance, indicating that improved bone density may enhance strength in powerlifters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of high-intensity resistance training on bone mineral density in young male powerlifters. Tsuzuku, S., Ikegami, Y., Yabe, K.[2019]

A new evaluation protocol for lifting techniques in powerlifting squats and deadlifts was developed, focusing on aspects associated with injury risk, and was validated by a consensus of experts and physiotherapists.

The final protocols included 17 aspects for squats and 10 for deadlifts, demonstrating good to excellent content validity and reliability, which can help coaches and practitioners provide evidence-based recommendations for safe lifting techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Content Validity Index and Reliability of a New Protocol for Evaluation of Lifting Technique in the Powerlifting Squat and Deadlift. Sjöberg, H., Aasa, U., Rosengren, M., et al.[2021]

Strength training significantly benefits adults by reducing the risk of muscle mass loss, functional decline, and fall-related injuries, especially in older adults who can achieve notable strength gains within a few months of starting a program.

Despite the health benefits, only 21.9% of men and 17.5% of women reported engaging in strength training two or more times per week in 2004, which is below the national health objective of 30% set for 2010, highlighting the need for more initiatives to promote strength training among adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends in strength training--United States, 1998-2004. [2022]

A review of 17 studies found that while strength training has well-documented benefits for physical health in overweight or obese individuals, its psychological effects are unclear and not convincingly supported by current evidence.

Some weak positive effects on psychological outcomes like self-efficacy and self-esteem were noted, but overall, the research indicates a significant gap in understanding the psychological benefits of strength training, highlighting the need for more comprehensive studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Psychological Effects of Strength Exercises in People who are Overweight or Obese: A Systematic Review. Ten Hoor, GA., Kok, G., Peters, GY., et al.[2019]

A six-month high-intensity strength-training program significantly increased trunk strength by 19.3% and lower limb strength (1RM squat) by 34.4% in women aged 50 and over, compared to an active control group.

While the strength training did not show a significant increase in lumbar bone mineral density (BMD), the control group experienced a decrease of 1.7%, suggesting that strength training may help maintain BMD in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying bone mass and muscular changes. Humphries, B., Mummery, K., Newton, RU., et al.[2016]

High-intensity strength training significantly improved bone mineral density in postmenopausal women, with increases in femoral neck and lumbar spine bone density, while control subjects experienced declines in bone density.

The strength training program also enhanced muscle mass, strength, and dynamic balance, demonstrating its effectiveness in reducing multiple risk factors for osteoporotic fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of high-intensity strength training on multiple risk factors for osteoporotic fractures. A randomized controlled trial. Nelson, ME., Fiatarone, MA., Morganti, CM., et al.[2019]

The LIFTMOR trial demonstrated that high-intensity progressive resistance training (HiPRT) with impact loading is safe and effective for improving bone health in postmenopausal women with low bone mass, with no reported injuries during the study.

Participants in the HiPRT group showed significant improvements in bone mineral density and functional performance compared to those in a low-intensity exercise group, indicating that high-intensity training can be beneficial for osteoporosis rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Watson, SL., Weeks, BK., Weis, LJ., et al.[2018]

Both high-load and high-repetition resistance training protocols significantly improved muscular strength and muscle size in early postmenopausal women, with lower body strength increasing by approximately 30% and hip strength by 37-40%.

Neither training protocol resulted in significant increases in bone mineral density (BMD) at the spine or hip, suggesting that while these exercises enhance muscular fitness, they may not be sufficient for improving bone density in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Musculoskeletal responses to high- and low-intensity resistance training in early postmenopausal women. Bemben, DA., Fetters, NL., Bemben, MG., et al.[2019]

References

1. Japan pubmed.ncbi.nlm.nih.gov

Impact of high-load resistance training on bone mineral density in osteoporosis and osteopenia: a meta-analysis. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

A Randomized Clinical Trial to Evaluate the Efficacy and Safety of the ACTLIFE Exercise Program for Women with Post-menopausal Osteoporosis: Study Protocol. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Power training improves bone mineral density and fall risk for a postmenopausal woman with a history of osteoporosis and increased risk of falling: A case report. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Maximal strength training in postmenopausal women with osteoporosis or osteopenia. [2016]

5. England pubmed.ncbi.nlm.nih.gov

Effect of specific exercise training on bone mineral density in women with postmenopausal osteopenia or osteoporosis. [2009]

6. United States pubmed.ncbi.nlm.nih.gov

Weightlifting, weight training and injuries. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Effects of high-intensity resistance training on bone mineral density in young male powerlifters. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Content Validity Index and Reliability of a New Protocol for Evaluation of Lifting Technique in the Powerlifting Squat and Deadlift. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Trends in strength training--United States, 1998-2004. [2022]

10. New Zealand pubmed.ncbi.nlm.nih.gov

The Psychological Effects of Strength Exercises in People who are Overweight or Obese: A Systematic Review. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Identifying bone mass and muscular changes. [2016]

12. United States pubmed.ncbi.nlm.nih.gov

Effects of high-intensity strength training on multiple risk factors for osteoporotic fractures. A randomized controlled trial. [2019]

13. England pubmed.ncbi.nlm.nih.gov

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. [2018]

14. United States pubmed.ncbi.nlm.nih.gov

Musculoskeletal responses to high- and low-intensity resistance training in early postmenopausal women. [2019]