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?

The aim of the 2 month randomized controlled trial is to investigate the feasibility of a novel progressive muscle resistance exercise in individuals with low bone mass.

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.

Is resistance exercise safe for people with osteoporosis?

Resistance exercise is generally considered safe for people with osteoporosis when done with proper guidance, as it can help maintain bone mass and reduce the risk of fractures. It's important to follow specific exercise protocols that consider age and physical condition to ensure safety. ^{1 2 3 4 5}

How does the treatment 'Novel Resistance Exercise' for osteoporosis differ from other treatments?

Novel Resistance Exercise is unique because it uses resistance training to directly apply mechanical force to bones, enhancing bone formation and reducing bone loss. This approach differs from traditional drug treatments by focusing on physical activity to improve bone strength and density. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Novel Resistance Exercise for osteoporosis?

Research shows that resistance exercises can enhance bone mineralization and may be more effective than weight-bearing activities in managing osteoporosis. Studies also indicate that exercise, including resistance training, helps preserve bone mass, prevent fractures, and improve quality of life in people with osteoporosis. ^{1 4 11 12 13}

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

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]

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]

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]

Citations

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

Exercise for osteoporosis--is walking enough? The case for site specificity and resistive exercise. [2019]

2. Japan pubmed.ncbi.nlm.nih.gov

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

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

A protocol for a randomised controlled trial of the bone response to impact loading or resistance training in young women with lower than average bone mass: the OPTIMA-Ex trial. [2022]

4. Greece pubmed.ncbi.nlm.nih.gov

Exercise for osteoporosis: how to navigate between overeagerness and defeatism. [2018]

5. Japan pubmed.ncbi.nlm.nih.gov

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

6. England pubmed.ncbi.nlm.nih.gov

Bone mineral density is increased after a 16-week resistance training intervention in elderly women with decreased muscle strength. [2017]

7. England pubmed.ncbi.nlm.nih.gov

Effects of dynamic resistance exercise on bone mineral density in postmenopausal women: a systematic review and meta-analysis with special emphasis on exercise parameters. [2021]

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

Exercise and bone mass in adults. [2022]

9. Japan pubmed.ncbi.nlm.nih.gov

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

10. 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]

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

Effect of exercise training and detraining on bone mineral density in postmenopausal women with osteoporosis. [2022]

12. Australia pubmed.ncbi.nlm.nih.gov

Effects of resistance training on bone parameters in young and mature rats. [2019]

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

Exercise for people with osteoporosis: translating the science into clinical practice. [2019]