NCT02847663

Brief Summary

This study investigates the effects of whole-body cryotherapy vs. cold-water immersion after a muscle damage protocol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 28, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

August 8, 2019

Status Verified

August 1, 2019

Enrollment Period

1.9 years

First QC Date

June 15, 2016

Last Update Submit

August 7, 2019

Conditions

Cold

Keywords

Coldrecovery

Outcome Measures

Primary Outcomes (8)

  • Vertical Jump

    Vertical Jump will be assessed in cm with the Just Jump Plate

    72 hours

  • Maximum voluntary contraction

    Maximum voluntary contraction will be assessed in kg on a custom made ergometer chair (COR 1)

    72 hours

  • Delayed onset of muscle soreness

    DOMS will be assessed using a visual analog scale (0-10 cm)

    72 hours

  • Ratings of perceived exertion

    RPE will be assessed using a BORG scale (6-20)

    72 hours

  • Skin temperature

    Skin temperature of the neck, right scapula, right dorsal hand, right frontal thigh, right shin are assessed in °C using thermocouples (iButtons)

    60 minutes

  • Core temperature

    Core temperature will be assessed in °C via the ear

    60 minutes

  • Cardiovascular measurements

    Heart rate will be measured in beats per minute and bloop pressure will be measured in mm/Hg using an blood pressure monitor

    60 min

  • Oxygenation of the right thigh muscle

    Oxygenation of the right thigh muscle will be assessed in % using a near infrared spectometer.

    60 min

Study Arms (2)

Whole-body cryotherapy

EXPERIMENTAL

The effects of whole-body cryotherapy (-135°C for 2 minutes) are investigated after a muscle damage protocol.

Device: Kryosauna Space Cabin

Cold-water immersion

OTHER

The effects of cold-water immersion (10°C for 15 minutes) are investigated after a muscle damage protocol.

Other: cold water tub

Interventions

Kryosauna Space CabinDEVICE

The whole body cryotherapy device is able to generatue temperatures up to -195°C for 3 minutes. In this study, we generate temperatures of -135°C for 2 minutes as proposed in the manual. The participant will enter the cabin in cold-resistant shoes and will remain in standing position during the whole procedure. The cold temperature is generated by vaporization of liquid nitrogen.

Also known as: Cryomed s.r.o.
Whole-body cryotherapy
cold water tubOTHER

The tub will be filled with cold water up to the sternal level of the participants. Adding ice will ensure a constant temperature. The participant will sit inside the tub during the whole procedure.

Cold-water immersion

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Only healthy young subjects 18-35 years no musculoskeletal surgery in trunk and lower extremities injury history in trunk and lower extremity for more than one year subjects taking anticonceptive medication are allowed to participate

You may not qualify if:

  • Actual injuries or injuries for less than one year in trunk and /or lower extremities injury history in trunk and lower extremity for more than one year with complaints anxiety of cooling subjects on medication pace maker cardiovascular disease pregnancy skeletal problems appendectomy for less than two years Morbus Raynaud syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fachhochschule Südschweiz

Landquart, 7302, Switzerland

Location

MeSH Terms

Conditions

Common Cold

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Ronaldus Clijsen, PhD

    Fachhochschule Südschweiz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD.

Study Record Dates

First Submitted

June 15, 2016

First Posted

July 28, 2016

Study Start

April 1, 2016

Primary Completion

March 1, 2018

Study Completion

June 1, 2018

Last Updated

August 8, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)