Resistance Exercise for Osteoporosis

Overseen By Donald Lein, PT, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must not be taking: Osteoporosis drugs

Disqualifiers: Hypertension, Osteoporosis, Fracture, Cancer, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new progressive muscle resistance exercise to determine its effectiveness for individuals with low bone mass, a condition that can lead to osteoporosis. Participants will either perform resistance exercises twice a week for six months or maintain their usual activities without new exercise routines. This trial suits individuals who can walk independently and have been diagnosed with low bone mass. However, those with conditions such as high blood pressure or a recent cancer history should not participate. The researchers aim to assess whether these exercises are easy to adhere to and effective in improving bone health. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance bone health for many.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but it does allow participants who are currently on zoledronic acid for osteoporosis.

What prior data suggests that this novel resistance exercise is safe for individuals with low bone mass?

Research shows that resistance exercise is generally safe for people with low bone mass. In the LIFTMOR trial, lifting heavy weights improved bone strength and physical function in postmenopausal women, with no major safety issues reported.

Another study found that resistance exercise effectively builds muscle and strength in middle-aged adults, consistently helping without significant problems.

These findings suggest that resistance exercise is well-tolerated, with participants usually not experiencing serious negative side effects.

Overall, evidence supports the safety of resistance exercise for improving bone health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the novel resistance exercise for osteoporosis because it offers a non-pharmacological approach to strengthening bones. Unlike standard treatments, which often rely on medications like bisphosphonates or hormone replacement therapy, this exercise regimen harnesses the body’s natural ability to build bone density through progressive muscle resistance. By focusing on targeted, structured exercise, it has the potential to improve bone health without the side effects associated with pharmaceuticals. Additionally, this method empowers individuals to take an active role in managing their condition, promoting overall fitness and wellbeing.

What evidence suggests that this novel resistance exercise is effective for osteoporosis?

Research shows that resistance exercise can improve bone health, especially for people with osteoporosis. This trial will evaluate a novel resistance exercise program. Studies have found that various exercises, including resistance training, positively affect bone mineral density (BMD), which is crucial for strong bones. For postmenopausal women, heavy resistance training has proven safe and significantly enhanced bone strength and function. In some cases, high-intensity resistance training led to better improvements in BMD than moderate intensity. Overall, exercise has slowed the loss of bone density, making it a promising option for those with low bone mass. ^{1 3 6 7 8}

Who Is on the Research Team?

HARSHVARDHAN SINGH, PT,PHD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for postmenopausal women who can walk on their own and have been diagnosed with low bone mass. It's not suitable for those with secondary osteoporosis, uncontrolled high blood pressure, current non-zoledronic acid osteoporosis treatments, liver or kidney disease, unmanaged thyroid issues, recent cancer history, previous year resistance training, inability to walk independently or a fragility fracture.

Inclusion Criteria

I have been diagnosed with low bone density.

I can walk by myself without help.

I can walk by myself without help.

Exclusion Criteria

Any other medical conditions which could restrict the potential participants from full participation as decided by their physician

You have done structured resistance training in the past year.

I have had cancer within the last 5 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive progressive muscle resistive exercise, 10 sets of exercises for 2 times per week

6 months

Regular exercise sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Novel Resistance Exercise

Trial Overview The study tests a new muscle-strengthening exercise program over six months to see if it's doable for women with weak bones after menopause. Participants are randomly chosen to either join the exercise group or be in a control group without this specific training.

How Is the Trial Designed?

Group I: Exercise training Experimental Treatment 1 Intervention

The exercise training group will receive progressive muscle resistive exercise, 10 sets of exercises for 2 times per week for a total of 6 months.

Group II: Control Active Control 1 Intervention

The control group will be asked to maintain their normal lifestyle and will be advised to continue their standard care of treatment.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

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]

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]

Exercise is an effective strategy for preventing and treating osteoporosis, as shown by randomized controlled trials and meta-analyses that indicate it helps preserve bone mass and prevent fractures and falls.

Specific exercise protocols tailored to an individual's age and physical condition are crucial for safely achieving positive outcomes in osteoporosis management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Daily practice using the guidelines for prevention and treatment of osteoporosis. Effectiveness of exercise for preventing and treating osteoporosis]. Miyakoshi, N.[2008]

Current interventional studies show that while exercise has some modest effects on improving bone mass in osteoporosis patients, these effects are not strong enough to justify exercise as a standalone treatment compared to drug therapies.

Exercise can effectively reduce or partially reverse bone loss in cases of musculoskeletal disuse, suggesting that optimizing exercise programs by considering factors like intensity and participant motivation could enhance their efficacy in treating osteoporosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise for osteoporosis: how to navigate between overeagerness and defeatism. Ireland, A., J Rittweger, J.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6279907/

Effects of Resistance Exercise on Bone Health - PMC Exercise training has been recommended as a promising therapeutic strategy to encounter the loss of bone and muscle mass due to osteosarcopenia.

2. sciencedirect.com sciencedirect.com/science/article/pii/S235218722200465X

A comparison of different exercise intensities for improving ... Postmenopausal women with osteoporosis may achieve more significantly improved lumbar spine BMD with HiRIT than with MiRIT.

3. mdpi.com mdpi.com/2077-0383/14/12/4109

Effectiveness of Exercise Loading on Bone Mineral Density ... The literature shows a positive effect of exercises such as resistance, aerobics, impact, whole-body vibration, and a combination of exercises on BMD and ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26243363/

novel early findings from the LIFTMOR trial Heavy resistance training is safe and improves bone, function, and stature in postmenopausal women with low to very low bone mass: novel early ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1155/2018/4840531

The Effectiveness of Physical Exercise on Bone Density in ... After two years of exercise, there was a significant reduction in the loss of BMD in the subjects being treated. This significant difference, ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28975661/

The LIFTMOR Randomized Controlled Trial Our novel, brief HiRIT program enhances indices of bone strength and functional performance in postmenopausal women with low bone mass.

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2835505

Weighted Vest Use or Resistance Exercise to Offset ... This randomized clinical trial of older adults with obesity examined whether weighted vest use added to weight loss better preserves bone ...

8. e-enm.org e-enm.org/journal/view.php?doi=10.3803/EnM.2018.33.4.435

Effects of Resistance Exercise on Bone Health RE has been frequently prescribed because it has been consistently shown to be safe and effective for improving muscle mass, size, and strength in middle-aged ...