Exercise and Bracing for Muscle Atrophy

(HYPAT Trial)

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 understand how muscles respond to different treatments. One leg will undergo unilateral resistance exercise training to build muscle, while a knee brace will keep the other leg still to observe muscle shrinkage. Researchers will study how these changes affect muscle proteins. The trial seeks healthy men who exercise no more than twice a week and have no history of muscle or bone diseases. As an unphased trial, participants can contribute to foundational research that may lead to new insights in muscle health.

Will I have to stop taking my current medications?

If you are taking medications that affect protein metabolism, like glucocorticoids or certain anti-inflammatory drugs, you will need to stop them to participate in this trial.

What prior data suggests that this protocol is safe?

Research has shown that resistance exercise is generally safe and well-tolerated. Studies have found that individuals aged 60-78 can increase muscle mass and strength without major safety concerns after a few weeks of training. Muscle mass changes ranged from a 5% decrease to a 9% increase, while strength improvements ranged from 9% to 57%. This suggests that resistance exercise is safe, though results can vary among individuals.

For knee bracing, the evidence is mixed. Some studies indicate that prolonged use of knee braces might lead to muscle weakness and reduced function. However, other research suggests that certain types of braces can help maintain muscle activity. Therefore, while knee braces are safe for short-term use, long-term use might cause unwanted effects like muscle loss.12345

Why are researchers excited about this trial?

Researchers are excited about the trial involving unilateral resistance exercise and unilateral immobilization because it explores non-invasive methods to address muscle atrophy. Unlike standard treatments that might focus on medication or whole-body exercise, this trial uniquely examines the effects of targeted, single-leg exercises and immobilization. This could help pinpoint specific strategies to preserve muscle in inactive limbs, potentially leading to more efficient rehabilitation techniques. By combining resistance training with strategic immobilization, researchers hope to better understand how to maintain muscle mass and function during periods of limited mobility.

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

This trial will compare the effects of Unilateral Resistance Exercise Training with Unilateral Immobilization using a knee brace. Research has shown that resistance exercise, such as weightlifting, prevents muscle loss and builds strength. One study found that participants who engaged in resistance training increased their leg press strength by up to 26.7% and their leg extension strength by 33.3%. Another study reported that after 10 weeks of this exercise, leg strength improved by about 19% for some exercises. In contrast, immobilizing a leg, as with a knee brace, often leads to muscle weakening and shrinkage. Studies have found that not using a muscle can reduce its strength by about 17% in just one week. These findings suggest that resistance exercise effectively combats muscle loss from inactivity.14678

Are You a Good Fit for This Trial?

Healthy males aged 18-30 with a BMI of 18.5 to 30 can join this study. They must be able to consent and not have muscle or bone diseases, serious illnesses, uncontrolled hypertension, diabetes, or take meds affecting protein metabolism. Non-smokers who don't drink excessively or exercise more than twice a week are eligible.

Inclusion Criteria

I am a healthy male aged between 18 and 30.
Your body mass index (BMI) is between 18.5 and 30.0.
Able and willing to provide informed consent

Exclusion Criteria

I am taking blood thinners.
You use tobacco products.
You drink more than 21 units of alcohol per week.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Unilateral Resistance Exercise

One leg will undergo 4 sessions of unilateral resistance exercise, over the course of 8 days, including leg press and leg extension.

8 days
4 sessions (in-person)

Unilateral Immobilization

One leg will undergo 14 days of single-leg immobilization using a removable knee brace.

14 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of muscle protein synthesis, lean mass, muscle strength, and muscle cross-sectional area.

2 weeks
3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Knee bracing
  • Unilateral Resistance Exercise Training
Trial Overview The trial is testing the effects of knee bracing and unilateral resistance exercise training on muscle size changes due to loading (exercise) and unloading (immobilization). It aims to understand individual molecular responses over an acute period using advanced proteomics techniques.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Unilateral Resistance ExerciseExperimental Treatment1 Intervention
Group II: Unilateral ImmobilizationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials
936
Recruited
2,630,000+

Published Research Related to This Trial

In a study of 24 patients with limb-girdle muscular dystrophy (LGMD), electrical stimulation significantly improved muscle strength in the Deltoideus compared to exercise therapy, with these benefits maintained during follow-up (p<0.05).
Overall, the electrical stimulation group showed greater improvements in muscle strength, endurance, and timed performance tests than the exercise therapy group, highlighting its potential as a more effective rehabilitation strategy for LGMD patients.
The effects of electrical stimulation and exercise therapy in patients with limb girdle muscular dystrophy. A controlled clinical trial.Kilinç, M., Yildirim, SA., Tan, E.[2018]
Resistance training (RT) is the only non-drug method proven to effectively counteract age-related declines in muscle mass, strength, and power, while also reducing risks of various health issues like cardiovascular disease and depression.
Minimal-dose RT strategies, which involve lower training volumes and can be performed with minimal equipment, are effective in improving strength and functional ability, making it easier for more people to participate and potentially enhancing overall health outcomes.
Minimal-Dose Resistance Training for Improving Muscle Mass, Strength, and Function: A Narrative Review of Current Evidence and Practical Considerations.Fyfe, JJ., Hamilton, DL., Daly, RM.[2022]
Resistance training at moderate intensities (40% and 60% of maximum contraction strength) is effective for promoting recovery from muscle atrophy in mice, as shown by improvements in muscle strength and myofiber size.
Training at very low (10%) or very high (90%) intensities did not support recovery, highlighting the importance of optimal training intensity for muscle regeneration and the role of myogenic satellite cells in muscle repair.
Training at non-damaging intensities facilitates recovery from muscle atrophy.Itoh, Y., Murakami, T., Mori, T., et al.[2018]

Citations

Single‐leg disuse decreases skeletal muscle strength, size ...The authors concluded that fixed immobilization methods resulted in greater skeletal muscle strength losses, but similar declines in skeletal ...
Correlation of Physical Activity Level with Muscle Strength and ...One week of unilateral knee joint immobilization did result in appreciable decrements in muscle strength and size, with a 17.1% and 6.7% ...
Effect of knee bracing on clinical outcomes following ...However, prolonged use of a knee brace can have negative consequences, such as muscle atrophy and a decline in function and proprioception. This is because ...
Does functional knee bracing cause muscle atrophy?These studies conclude that functional bracing does not cause muscle atrophy. In fact, they show that muscles are more active with functional bracing.
The effects of single-leg disuse on skeletal muscle strength ...We recently conducted a systematic review and meta-analysis of 40 single-leg immobilization studies that demonstrated marked reductions in both skeletal muscle ...
Correlation of Physical Activity Level with Muscle Strength ...One week of unilateral knee joint immobilization did result in appreciable decrements in muscle strength and size, with a 17.1% and 6.7% decrease in MVC peak ...
Effect of knee bracing on clinical outcomes following ...However, prolonged use of a knee brace can have negative consequences, such as muscle atrophy and a decline in function and proprioception.
Study ProtocolWhile it remains to be determined if GH can protect a muscle from atrophy after joint injury and with a longer period of immobilization and limited activity, ...
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