| CTRI Number |
CTRI/2018/07/015111 [Registered on: 30/07/2018] Trial Registered Retrospectively |
| Last Modified On: |
04/04/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The influence of ambient temperature on inflammation in humans. |
|
Scientific Title of Study
|
The influence of ambient temperature changes on inflammatory markers in blood. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Celestyna MilaKierzenkowska |
| Designation |
Ph.D., D.Sc. |
| Affiliation |
Collegium Medicum of Nicolaus Copernicus University |
| Address |
Facualty of Medicine The Chair of Medical Biology Karlowicza 24 Bydgoszcz Poland
85-092
Other |
| Phone |
48525853740 |
| Fax |
48525853742 |
| Email |
celestyna@go2.pl |
|
Details of Contact Person
Scientific Query
|
| Name |
Marta Pawowska |
| Designation |
M.Sc. |
| Affiliation |
Collegium Medicum of Nicolaus Copernicus University |
| Address |
Facualty of Medicine The Chair of Medical Biology Karlowicza 24 Bydgoszcz Poland
85-092
Other |
| Phone |
48525853740 |
| Fax |
48525853742 |
| Email |
pawlowska.marta.89@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Marta Pawłowska |
| Designation |
M.Sc. |
| Affiliation |
Collegium Medicum of Nicolaus Copernicus University |
| Address |
Facualty of Medicine The Chair of Medical Biology Karlowicza 24 Bydgoszcz Poland
85-092
Other |
| Phone |
48525853740 |
| Fax |
48525853742 |
| Email |
pawlowska.marta.89@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Chair of Medical Biology, Nicolaus Copernicus University, Ludwik Rydygier Collegium Medicum in Bydgoszcz, Poland |
|
|
Primary Sponsor
|
| Name |
Ludwik Rydygier Collegium Medicum in Bydgoszcz NicolausCopernicus University in Torun Poland |
| Address |
ul. Karlowicza 24, 95-092 Bydgoszcz, Poland |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Poland |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Celestyna MilaKierzenkowska |
Nicolaus Copernicus University, Ludwik Rydygier Collegium Medicum in Bydgoszcz, Poland |
The Chair of Medical
Biology, Karlowicza 24,
85-092 Bydgoszcz,
Poland
|
48525853740
celestyna@go2.pl |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bioethics Committee at Collegium Medicum in Bydgoszcz of Nicolaus Copernicus University in Torun, Poland |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy men, treated for any co-morbidities. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cold water immersion. |
The volunteers were subjected to 30-min exercise on a bicycle ergometer followed by 3-minute bath in a pool with cold water (8° C). |
| Comparator Agent |
rest at room temperature in a sitting position |
The volunteers were subjected to 30-min exercise on a bicycle ergometer and rest at room temperature in a sitting position |
| Intervention |
Sauna bath |
The volunteers were subjected to 30-min exercise on a bicycle ergometer followed by sauna bath. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
healthy persons, non-smokers |
|
| ExclusionCriteria |
| Details |
Persons treated for any co-morbidities, smoking cigarettes and using a diet that could affect inflammation rates were excluded from the study. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Examination of patients’ peripheral blood serum activity of arylsulfatase, acid
phosphatase, cathepsin D, alpha1-antitrypsin.
|
The experimental material was venous blood taken from the basilic vein into vacuum test
tubes three times for each participant (before exercise, 2 and 20 minutes after exercise): for
blood serum (clot activator and gel separator).
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Examination of patients’ peripheral blood serum concentration of interleukin 6 (IL-6), interleukin 10 (IL-10), tumor necrosis factor α (TNF-α) and transforming growth factor β1 (TGF-β1) and C-reactive protein (CRP)
|
The experimental material was venous blood taken from the basilic vein into vacuum test
tubes three times for each participant (before exercise, 2 and 20 minutes after exercise): for
blood serum (clot activator and gel separator).
|
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="0"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
26/04/2016 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Applicable |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study will assess the impact of postexercise sauna treatment and cold water immersion on inflammation markers in blood. The organism reaction to ambient temperature changes is regulated by a number of substances. Detailed analysis of changes in the concentration of selected interleukins, C-reactive protein and the activity of lysosomal enzymes and protease inhibitor, the substances potentially involved in the body’s reaction to ambient temperature changes, can identify factors that play a key role in the mechanism of adaptation to thermal stress |