Strength Training for Osteoporosis

(STOP-EM Trial)

Overseen By Charley Hasselaar

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Calgary

Must not be taking: Glucocorticoids, Osteoporosis drugs

Disqualifiers: Pregnancy, Orthopaedic conditions, Cardiovascular, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 9 months

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are using glucocorticoids or have been treated with osteoporosis medications, you may not be eligible to participate.

What data supports the effectiveness of the treatment Resistance Training, Strength Training, Weight Training, Bodybuilding, Powerlifting, Muscle Building, Fitness Training for osteoporosis?

Research shows that resistance training can improve bone mineral density and reduce fall risk in older adults with osteoporosis. A study found that a 12-month power-based resistance-training program increased bone density and improved balance in a postmenopausal woman with osteoporosis. ^{1 2 3 4 5}

Is strength training safe for humans?

Strength training is generally safe for humans, with serious adverse events being uncommon. It offers health benefits like improved physical functioning and reduced risk of diseases, and the benefits usually outweigh the risks. ^{6 7 8 9 10}

How does resistance training differ from other treatments for osteoporosis?

Resistance training is unique because it directly targets muscle strength and bone density through high-intensity exercises, which can improve bone health and reduce fall risk, unlike other treatments that may focus solely on medication or less intensive physical activity. ^{1 2 11 12 13}

What is the purpose of this trial?

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.

Research Team

Leigh Gabel, PhD

Principal Investigator

University of Calgary

Eligibility Criteria

This trial is for women aged 45-60 who are in peri- or early menopause, not currently doing resistance training, and have no recent severe fractures or conditions worsened by exercise. They shouldn't be pregnant nor planning pregnancy soon, without metabolic bone diseases, active steroid use, or low vitamin D/calcium levels.

Inclusion Criteria

I am in the early or peri-menopausal stage, within 5 years of my last period.

I am between 45 and 60 years old.

Exclusion Criteria

I have had a bone fracture due to osteoporosis in the last 5 years.

I am not pregnant nor planning to become pregnant in the next year.

Your blood test shows low levels of vitamin D or calcium.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 9-month supervised, progressive resistance training program

9 months

Twice weekly, in-person visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Resistance Training

Trial Overview The study tests if a high-intensity resistance training program over 9 months is practical for participants to follow. It will also look at the effects on bone health, muscle strength, and menopausal symptoms compared to a group that waits to start the program.

Participant Groups

Group I: Exercise Experimental Treatment 1 Intervention

In-person, supervised resistance training program

Group II: Control Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Findings from Research

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]

In a review of 121 trials involving 6700 older adults, most adverse events related to progressive resistance strength training were musculoskeletal issues like muscle strains and joint pain, particularly in participants with pre-existing health conditions or those engaging in high-intensity training.

Adverse events were often underreported, highlighting the need for clearer definitions and consistent reporting in future studies to better inform practitioners about the risks and benefits of strength training in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events reported in progressive resistance strength training trials in older adults: 2 sides of a coin. Liu, CJ., Latham, N.[2010]

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]

Resistance training (RT) significantly reduces all-cause mortality and the incidence of cardiovascular disease while improving physical functioning in adults, based on an analysis of 11 systematic reviews involving over 382,000 participants.

Although adverse events were not consistently reported, serious adverse events related to RT were uncommon, suggesting that the benefits of resistance training outweigh the potential harms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resistance training and health in adults: an overview of systematic reviews. El-Kotob, R., Ponzano, M., Chaput, JP., et al.[2021]

Strength training is crucial for older adults (65 years and older) as it enhances health by improving muscular strength, endurance, and bone density, while also reducing the risk of falls and fractures.

Only about 12% of adults aged 65-74 and 10% of those aged 75 and older engage in strength training at least twice a week, highlighting the need for programs to promote strength training among older populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strength training among adults aged >/=65 years--United States, 2001. [2008]

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]

References

1. Singapore pubmed.ncbi.nlm.nih.gov

Muscle strength rather than muscle mass is associated with osteoporosis in older Chinese adults. [2018]

2. 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]

3. England pubmed.ncbi.nlm.nih.gov

Effects of resistance training on body composition and physical function in elderly patients with osteosarcopenic obesity: a systematic review and meta-analysis. [2023]

4. England pubmed.ncbi.nlm.nih.gov

The effects of resistance training volume on osteosarcopenic obesity in older women. [2018]

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

Efficacy of heavy-resistance training for active women over sixty: muscular strength, body composition, and program adherence. [2019]

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

Adverse events reported in progressive resistance strength training trials in older adults: 2 sides of a coin. [2010]

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

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

8. Canada pubmed.ncbi.nlm.nih.gov

Resistance training and health in adults: an overview of systematic reviews. [2021]

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

Strength training among adults aged >/=65 years--United States, 2001. [2008]

10. England pubmed.ncbi.nlm.nih.gov

Strength Training and All-Cause, Cardiovascular Disease, and Cancer Mortality in Older Women: A Cohort Study. [2018]

11. Japan pubmed.ncbi.nlm.nih.gov

[Influences of resistance training on bone.] [2017]

12. 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]

13. Germany pubmed.ncbi.nlm.nih.gov

[New strategies for exercise training in osteoporosis]. [2018]