Strength Training Intensity for Osteoporosis

Not currently recruiting at 2 trial locations
KS
DV
Overseen ByDave Varandas, BSc
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Waterloo
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how varying exercise intensities impact bone health in individuals with low bone mineral density, a condition that weakens bones and increases fracture risk. Participants will engage in different types of strength training, including supervised sessions, to identify the most effective method for strengthening bones. The trial seeks individuals with low bone mineral density who have been postmenopausal for at least two years and are willing to exercise twice a week. As an unphased trial, it provides participants the chance to contribute to valuable research that could enhance bone health strategies for many.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that supervised high-intensity resistance training, which involves lifting heavy weights, is generally safe for individuals with low bone density. This exercise can strengthen bones. For instance, one study found that this training improved bone density in key areas like the hip. Another study demonstrated that it also reduces factors that increase fracture risk, benefiting bone health.

Participants in these studies typically managed the exercises well, with no major safety issues reported. This suggests that supervised strength training is a safe method to strengthen bones. However, following advice from trained professionals is crucial to ensure exercises are performed safely and correctly.12345

Why are researchers excited about this trial?

Researchers are excited about the strength training approach for osteoporosis because it focuses on the intensity of the exercises, which could be key in improving bone health. Traditional treatments often rely on medications like bisphosphonates or lifestyle changes such as diet and basic exercise. However, this approach highlights supervised, specific-intensity strength training, which might directly enhance bone density and muscle strength more effectively. Additionally, the comparison between in-person supervised sessions and home-based exercises with virtual support could reveal valuable insights into the best ways to manage osteoporosis. This trial aims to uncover how different exercise intensities impact bone health, potentially paving the way for more personalized and effective treatment strategies.

What evidence suggests that this trial's treatments could be effective for osteoporosis?

Research has shown that high-intensity strength training effectively increases bone mass, particularly in the spine and hips. This exercise involves lifting heavier weights, which puts more pressure on the bones and promotes growth. One study found that resistance training significantly improved bone strength in key areas like the lower spine and the top of the thigh bone. Another study demonstrated that a year of heavy resistance training led to short-term bone growth benefits in older adults. In this trial, participants will join different treatment arms, including supervised strength training (group 1 and group 2) and a home exercise program. Overall, these findings suggest that supervised strength training can be a promising way to combat bone loss in people with osteoporosis.36789

Who Is on the Research Team?

LG

Lora Giangregorio, PhD

Principal Investigator

University of Waterloo

Are You a Good Fit for This Trial?

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.
See 4 more

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.
See 10 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: Supervised strength training (group 2)Experimental Treatment1 Intervention
Group II: Supervised strength training (group 1)Experimental Treatment1 Intervention
Group III: Home exerciseActive Control1 Intervention

Find a Clinic Near You

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+

Published Research Related to This Trial

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.
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.
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.
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

Effects of Resistance Exercise on Bone Health - PMCExercise training has been recommended as a promising therapeutic strategy to encounter the loss of bone and muscle mass due to osteosarcopenia.
Effect of different types of exercise on bone mineral density ...Notably, high-intensity strength training is more effective at increasing bone mass in the spine and hips than low-intensity or moderate- ...
Optimal resistance training parameters for improving bone ...The results indicate that resistance training significantly improves BMD at the LS (SMD = 0.88, 95% CI [0.21, 1.56], P = 0.01, I2 = 91%), FN ( ...
Heavy resistance training provides short-term benefits on ...We demonstrated that 1 year of heavy resistance training positively influenced short-term bone formation in well-functioning older adults, although the effect ...
Comparative efficacy different resistance training protocols ...The results of the network Meta-analysis showed that moderate intensity resistance training was superior in improving lumbar spine bone mineral ...
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/32289518/
The LIFTMOR-M semi-randomised controlled trialFindings indicate that supervised HiRIT provides a positive stimulus to cortical bone at the medial FN compared with supervised IAC exercise.
Effects of supervised high-intensity resistance and impact ...High-intensity resistance and impact training improves fracture risk factors in men. Abstract. Introduction. Few data exist on the effects of bone-targeted ...
LIFTMOR Controlled Trial for Osteoporosis and Low Bone ...This study revealed something exciting: postmenopausal women who followed the LIFTMOR exercise program showed significantly greater improvements ...
Position Statement: Exercise Guidelines for Osteoporosis ...The 50 RCTs reported that even with osteoporosis and osteopenia, resistance and impact training consistently maximized bone strength, improved body strength and ...
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