NCT03776734

Brief Summary

It is of utmost importance to determine the individual upper limits in the recommended exercises for increasing the level of physical activity and for developing the cardiovascular system. Cardiovascular exercise tests are used in determining the exercise capacity and performance. Cardiovascular exercise tests allow maximal and submaximal loadings to determine the person's body temperature, oxygen consumption, fatigue, interpretation of cardiac responses, and exercise capacity. Thermal equilibrium is achieved by the activation or inhibition of autonomic and behavioral thermocouples in order to generate, dissipate or protect heat. These thermocouples act together and allow precise control of body temperature, which is arranged in a narrow range. Under certain conditions, such as body temperature, systemic inflammation, extreme environmental conditions, and exercise performance, it falls outside this narrow range. Metabolic heat production is 15 to 20 times greater than resting during exercise. In exercise performed under hot ambient conditions, the rate of heat production will exceed the rate of heat loss and cause it to rise rapidly before reaching a plateau. The increase due to the exhalation of body heat initiates two autonomous thermodynamics for heat dissipation: sweating and cutaneous vasodilatation. Although both mechanisms help prevent exaggerated increase in body temperature, they cause stress for the cardiovascular system. Exercise performance and level of physical activity are influenced by individual characteristics such as personality adjustment and mediocre adjustment. Adaptation is defined as adaptation under natural conditions. Robinson showed that the individual salt losses are higher in individuals who exercise in a hot environment and cannot adapt to the temperature, a decrease in both urine and sweat salt contents with temperature compliance. One research has shown that exercise performance is influenced by heat-induced muscle cramps and cardiovascular function disorders due to this significant increase in salt loss. An increase in body temperature caused by exercise can have a negative impact on exercise performance and may lead to the development of conditions associated with increased body temperature. Although many studies in literature have shown positive effects of performance of pre-exercise cold exercise on performance, there is no consensus on the use of cold applications.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

July 30, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 17, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

February 7, 2019

Status Verified

February 1, 2019

Enrollment Period

11 months

First QC Date

November 9, 2018

Last Update Submit

February 6, 2019

Conditions

Keywords

precoolingexercisepulmonary functionisokineticlactate

Outcome Measures

Primary Outcomes (1)

  • Exercise capacity

    Oxygen consumption on maximal exercise test (Bruce Protocol) will be assessed with mobile metabolic analyzer system as expended oxygen level per kilogram in one minute (ml/kg/min.) will be measured after cold application.

    Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.

Secondary Outcomes (10)

  • Muscle strength

    Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.

  • Muscle endurance

    Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.

  • Forced expiratory volume

    Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.

  • Forced vital capacity

    Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.

  • Peak expiratory flow

    Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.

  • +5 more secondary outcomes

Study Arms (1)

cryotherapy application

EXPERIMENTAL

effect of cold application

Other: Cryotherapy application

Interventions

Effects of 5-10- 20 minutes cold application on quadriceps muscle

cryotherapy application

Eligibility Criteria

Age18 Years - 25 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male, healthy individuals between the ages of 18-25
  • individuals without peripheral circulatory disturbances
  • Individuals without chronic disease
  • Individuals without orthopedic, neurological, cardiopulmonary disturbances that may prevent evaluation and measurement
  • individuals who have not exercised regularly in the past six months

You may not qualify if:

  • Individuals with sensory loss
  • Individuals with cold hypersensitivity
  • Drug users who may influence performance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Mediterranean University

Famagusta, Cyprus

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • İLKER YATAR, MSc. PT

    Eastern Mediterranean University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

İLKER YATAR, MSc. PT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior İnstructor

Study Record Dates

First Submitted

November 9, 2018

First Posted

December 17, 2018

Study Start

July 30, 2018

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

February 7, 2019

Record last verified: 2019-02

Locations