NCT06815367

Brief Summary

Both BFR and intermittent pneumatic compression are purported to decrease symptoms associated with exercise induced muscle damage (EIMD) that cause delayed onset muscle soreness (DOMS). Blood flow restriction relies on applying pressurized cuffs to the most proximal portion of the limb. Another form of recovery often relied upon is pneumatic compression. The mechanism by which pneumatic compression works is similar to that of a massage, whereby the device progressively increases the pressure on a portion of the limb before releasing and moving further up the limb.The purpose of this study is determine whether BFR or pneumatic compression can be used to decreased DOMS which may indicate enhanced recovery.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2024

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 7, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

March 30, 2026

Status Verified

August 1, 2025

Enrollment Period

1.9 years

First QC Date

September 17, 2024

Last Update Submit

March 24, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • Counter Movement Jump Height

    Participants will be asked to complete three consecutive counter movement jumps with hands on hips. The CMJ will be used as an indirect measure of muscle function.

    Immediately before and immediately after exercise, immediately after treatment, 24-hours post treatment.

  • Maximal Voluntary Isometric Contraction

    Participants will be asked to complete an MVIC to assess muscle function.

    Immediately before and immediately after exercise, immediately after treatment, 24-hours post treatment.

  • Sedentary delayed onset muscle soreness

    Using a visual analog scale, participants will be asked to rate their level of soreness while at rest.

    Immediately before and immediately after exercise, immediately after treatment, 24-hours post treatment.

  • Active delayed onset muscle soreness

    Using a visual analog scale, participants will be asked to rate their level of soreness while completing a wall sit.

    Using a visual analog scale, participants will be asked to rate their level of soreness while at rest.

Study Arms (3)

Control

NO INTERVENTION

The participants will be asked to refrain from exercise 24 hours prior to and following the exercise. Participants will complete all pre-exercise tests (DOMS, CMJ, MVIC). The exercise consists of running on a treadmill situated at a -10% grade at 9 km/hr (5.59 mph) for 20 minutes. This is proceeded and followed by 5 minute warm-up/cool-down periods. Those that are allocated to the "control" group, will not receive treatment after the downhill running protocol.

Pneumatic compression

EXPERIMENTAL

The participants will be asked to refrain from exercise 24 hours prior to and following the exercise. Participants will complete all pre-exercise tests (DOMS, CMJ, MVIC). The exercise consists of running on a treadmill situated at a -10% grade at 9 km/hr (5.59 mph) for 20 minutes. This is proceeded and followed by 5 minute warm-up/cool-down periods. Those allocated to the "pneumatic compression" group will receive 20 minutes of pneumatic compression at 100 mmHg.

Device: Pneumatic Compression

Blood flow restriction

EXPERIMENTAL

The participants will be asked to refrain from exercise 24 hours prior to and following the exercise. Participants will complete all pre-exercise tests (DOMS, CMJ, MVIC). The exercise consists of running on a treadmill situated at a -10% grade at 9 km/hr (5.59 mph) for 20 minutes. This is proceeded and followed by 5 minute warm-up/cool-down periods. Those allocated to the "BFR" group will receive 4 rounds of treatment: 3 minutes will be spent at 100% of resting limb occlusion pressure, followed by 2 minutes of 0% occlusion.

Device: Blood Flow Restriction

Interventions

Following the downhill running protocol, participants will complete 4 rounds of treatment: 3 minutes at 100% resting limb occlusion pressure, 2 minutes of 0% resting limb occlusion pressure.

Blood flow restriction

Following downhill running protocol, participants will complete 20 minutes of pneumatic compression at 100 mmHg.

Pneumatic compression

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years of age
  • Recreationally active population
  • Women should be on a form of hormonal contraception.
  • No current musculoskeletal injuries or pathologies
  • Must answer "yes" to all PAR-Q questions.

You may not qualify if:

  • Individuals that routinely train trail running
  • Discomfort when running
  • Deep vein thrombosis
  • Blood clots
  • Cancerous lesions
  • Sensory or mental impairment
  • Unstable fractures
  • Acute pulmonary edema
  • Acute thrombophlebitis
  • Acute congestive cardiac failure
  • Acute infections
  • Episodes of pulmonary embolism
  • Wounds, lesions, infection, or tumors
  • Bone fractures or dislocations
  • Increased venous and lymphatic return
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern California

Los Angeles, California, 90033, United States

RECRUITING

MeSH Terms

Interventions

Intermittent Pneumatic Compression DevicesBlood Flow Restriction Therapy

Intervention Hierarchy (Ancestors)

Equipment and SuppliesExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Central Study Contacts

Bailey McLagan, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 17, 2024

First Posted

February 7, 2025

Study Start

January 15, 2024

Primary Completion

December 1, 2025

Study Completion

May 1, 2026

Last Updated

March 30, 2026

Record last verified: 2025-08

Locations