NCT02530190

Brief Summary

The study is a randomized clinical trial examining the effectiveness of massage and intermittent pneumatic compression on recovery from a 161-km ultramarathon.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2015

Completed
Last Updated

August 20, 2015

Status Verified

August 1, 2015

Enrollment Period

2 months

First QC Date

August 18, 2015

Last Update Submit

August 19, 2015

Conditions

Musculoskeletal Pain

Outcome Measures

Primary Outcomes (1)

  • 400 m run time

    self-timed 400 m run as fast as possible

    5 days

Secondary Outcomes (2)

  • Lower body muscle pain and soreness rating

    5 days

  • Overall muscular fatigue score

    5 days

Study Arms (3)

Control

NO INTERVENTION

20 minutes of supine rest

Intermittent pneumatic compression

ACTIVE COMPARATOR

20 minutes of intermittent pneumatic compression

Device: intermittent pneumatic compression

Massage

ACTIVE COMPARATOR

20 minutes of massage therapy

Procedure: massage

Interventions

intermittent pneumatic compressionDEVICE

20 minutes of intermittent pneumatic compression to lower extremities

Intermittent pneumatic compression
massagePROCEDURE

20 minutes of massage to lower extremities

Massage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Entry in the Western States Endurance Run

You may not qualify if:

  • Failure to finish race

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Northern California Health Care System

Sacramento, California, 95655, United States

Location

Related Publications (1)

  • Hoffman MD, Badowski N, Chin J, Stuempfle KJ. A Randomized Controlled Trial of Massage and Pneumatic Compression for Ultramarathon Recovery. J Orthop Sports Phys Ther. 2016 May;46(5):320-6. doi: 10.2519/jospt.2016.6455. Epub 2016 Mar 23.

    PMID: 27011305DERIVED

MeSH Terms

Conditions

Musculoskeletal Pain

Interventions

Intermittent Pneumatic Compression DevicesMassage

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and SuppliesTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

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
Director of Research

Study Record Dates

First Submitted

August 18, 2015

First Posted

August 20, 2015

Study Start

May 1, 2015

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

August 20, 2015

Record last verified: 2015-08

Locations

US(1)