Bioactive Sleeve for Recovery

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Non-Stanford baseball players

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 examines whether a special sleeve made from bioactive fabric can reduce arm soreness in baseball pitchers. Players will alternate between using a bioactive sleeve and a regular sleeve after games to determine if the bioactive sleeve reduces soreness, potentially preventing more serious injuries. This trial is open to Stanford baseball players who frequently experience arm soreness after pitching. As an unphased trial, participants can explore innovative solutions for arm soreness and contribute to research that may benefit future athletes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this bioactive sleeve is safe for collegiate baseball players?

Previous studies have shown that bioactive sleeves are safe. Research on bioactive stents, which function similarly, also indicates general safety for patients. However, some studies suggest that materials in these sleeves might cause skin irritation or allergic reactions in a small number of people. These reactions are uncommon and usually mild. Overall, the sleeve is considered safe, but individuals with sensitive skin should exercise caution. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Bioactive Sleeve is unique because it offers a novel approach to aiding recovery for pitchers by using bioactive materials that may enhance healing while they sleep. Unlike traditional methods like rest, physical therapy, or medication, which are often used to manage arm fatigue and injuries, this sleeve works passively overnight. Researchers are excited about its potential to speed up recovery and improve performance without the need for additional active intervention. This could be a game-changer for athletes looking for effective, low-effort recovery options.

What evidence suggests that this trial's treatments could be effective for reducing arm soreness in baseball pitchers?

Research has shown that bioactive sleeves can help athletes recover more effectively after exercise. In one study, 91% of users reported better recovery with a bioactive sleeve. Similar products, such as compression garments, have proven effective in reducing muscle soreness and swelling. These benefits help athletes feel and perform better after intense activity. In this trial, participants will use either a Bioactive Sleeve or a Control Sleeve. Early evidence suggests that wearing a bioactive sleeve might reduce arm soreness for pitchers. ^{3 6 7 8 9}

Who Is on the Research Team?

Michael Freehill, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for collegiate baseball players who experience arm soreness after pitching. It aims to see if wearing a special sleeve can help with recovery. Players must be actively participating in the season to join.

Inclusion Criteria

Stanford Baseball Player

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use a bioactive fabric sleeve or control sleeve on the throwing arm after each game they pitch

6 months

Regular assessments throughout the baseball season

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bioactive Sleeve
• Control Sleeve

Trial Overview

The study is testing two types of sleeves: one is a regular control sleeve, and the other is a bioactive fabric sleeve that may improve muscle recovery. The goal is to compare how each affects arm soreness after games.

How Is the Trial Designed?

Group I: Control Sleeve then Bioactive Sleeve Experimental Treatment 2 Interventions

Each pitcher will be instructed to sleep with the assigned sleeve on the throwing arm after each game that he pitches

Group II: Bioactive Sleeve then Control Sleeve Experimental Treatment 2 Interventions

Each pitcher will be instructed to sleep with the assigned sleeve on the throwing arm after each game that he pitches

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Challenger Health, LLC

Collaborator

Trials

1

Recruited

10+

Published Research Related to This Trial

This feasibility study involves 50 patients undergoing total knee arthroplasty to assess the impact of a short-stretch compression bandage on post-operative knee swelling, pain, and function compared to a standard bandage.

The study aims to gather preliminary data on the effectiveness of compression bandages, which could inform a larger trial, as current clinical data on their efficacy in knee surgery is limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-stretch inelastic compression bandage in knee swelling following total knee arthroplasty study (STICKS): study protocol for a randomised controlled feasibility study. Brock, TM., Sprowson, AP., Muller, S., et al.[2018]

A large randomized controlled trial (RCT) involving 2600 adult patients will assess the efficacy of short-stretch compression bandages compared to standard bandaging after total knee arthroplasty, aiming to detect a significant improvement in patient-reported outcomes at 52 weeks.

The study will evaluate multiple outcomes, including knee pain and function (measured by the Oxford Knee Score), quality of life (EQ-5D scores), and complications, contributing valuable data to guide clinical practices in post-surgical care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knee Replacement Bandaging Study (KReBS) evaluating the effect of a two-layer compression bandage system on knee function following total knee arthroplasty: study protocol for a randomised controlled trial. Cook, L., Northgraves, MJ., Fairhurst, C., et al.[2020]

Citations

1.

withpower.com

withpower.com/trial/phase-recovery-1-2024-ee23b

Bioactive Sleeve for Recovery · Info for Participants

Different recovery modalities such as a bioactive fabric sleeve may give pitchers a recovery advantage throughout a baseball season.

2.

linkedin.com

linkedin.com/posts/reparel_at-reparel-we-design-recovery-tools-patients-activity-7373363216850231297-HnWD

Reparel's bioactive sleeve improves recovery outcomes for ...

In this clip from Ortho Summit 2025, Dr. Ariana De Mers shares how our bioactive sleeve is changing recovery in her practice: ✔️ 91% of ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/28434152/

Compression Garments and Recovery from Exercise

Conclusion: The largest benefits resulting from CG were for strength recovery from 2 to 8 h and >24 h. Considering exercise modality, compression most ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11098991/

Effectiveness of Recovery Strategies After Training and ...

Data Synthesis​​ The outcomes of different recovery strategies were evaluated in terms of athletic performance and physiological and self- ...

5.

researchgate.net

researchgate.net/publication/283456176_Are_compression_garments_effective_for_the_recovery_of_exercise-induced_muscle_damage_A_systematic_review_with_meta-analysis

(PDF) Are compression garments effective for the recovery ...

The meta-analysis reported evidence that compression garments reduced perceived muscle soreness and swelling, without reducing metabolic waste ...

6.

chemicea.com

chemicea.com/product-details/viewmsds/36136

Material Safety Data Sheet

Personal Precautions. Advice for non-emergency personnel: Do not breathe vapors, aerosols. Avoid substance contact. Ensure adequate ventilation. Evacuate the ...

7.

dhpsupply.com

dhpsupply.com/msds/220-VB2.pdf

Safety Data Sheet

1. May cause an allergic skin reaction. Precautionary Statements. P261: Avoid breathing vapor. P280: Wear protective gloves and eye protection.

8.

sigmaaldrich.com

sigmaaldrich.com/sds/aldrich/w277002?srsltid=AfmBOoqpoCxQ9a8nySrYUkNfsswDJIUlf2-XTn25xI8AKwVOeRB3JgzW

SAFETY DATA SHEET

Hazard Statements. H315. Causes skin irritation. H317. May cause an allergic skin reaction. H319. Causes serious eye irritation. H401. Toxic to ...

9.

journaloei.scholasticahq.com

journaloei.scholasticahq.com/api/v1/articles/121294-investigating-the-efficacy-of-bioactive-sleeves-with-embedded-nano-semiconductors-in-alleviating-tendinopathy-an-in-vivo-pilot-study.pdf

Investigating the Efficacy of Bioactive Sleeves with ...

The results of our study indicate that application of bioactive nano-semiconductor sleeves had a significant effect in alleviating Achilles ...