|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ISRCTN |
|
Last refreshed on:
|
18 September 2023 |
|
Main ID: |
ISRCTN13033050 |
|
Date of registration:
|
21/08/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Physical Activity Initiated by Employer and its health effects: an eight-week follow-up study
|
|
Scientific title:
|
Physiological effects of employers motivated physical activity |
|
Date of first enrolment:
|
01/08/2014 |
|
Target sample size:
|
100 |
|
Recruitment status: |
Completed |
|
URL:
|
https://www.isrctn.com/ISRCTN13033050 |
|
Study type:
|
Observational |
|
Study design:
|
Single-center observational prospective study (Prevention)
|
|
Phase:
|
Not Applicable
|
|
|
Countries of recruitment
|
|
Norway
| | | | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
Marit
Skogstad |
|
Address:
|
National Institute of Occupational Health
0033
Oslo
Norway |
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: Healthy volunteers aged over 18
Exclusion criteria: Some disorders will disqualify for participation in the study, such as serious heart disease and cancer
Age minimum:
Age maximum:
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
Cardiovascular status
Circulatory System
|
|
Intervention(s)
|
All subjects participating in the physical activity program got organized in teams and competed against each other in a virtual internet mountain track. Steps measured by a wrist-band pedometer were recorded on the personally designated profile on the competition website. Both team and individual performances could be continuously monitored and the best performance was rewarded at the end of the program.
Maximal oxygen uptake, blood pressure, resting heart rate (RHR) and blood samples (glycosylated hemoglobin, lipids and C-reactive protein) were obtained at baseline and after eight weeks.
|
|
Primary Outcome(s)
|
|
Aerobic fitness was tested using a graded test on a cycle ergometer (Monark 874 E, Monark Exercise AB, Vansbro, Sweden). The starting load was 70 W with a cadence of 70 revolutions per minute (RPM). Every minute the resistance was increased by 35 W until the subject was exhausted (cadence <65 RPM). Oxygen uptake was measured continuously with a Cosmed K4b2 breath by a breath metabolism analyser (Cosmed Srl, Rome, Italy) and was calculated from the highest 30 s averaging interval at the conclusion of the test.
|
|
Secondary Outcome(s)
|
1. Blood pressure and resting heart rate (RHR) were measured on the left arm after five minutes of rest. The measurements were taken three times in intervals of one minute. The average of the last two measurements of both the systolic (sBP) and the diastolic pressure (dBP) was used in the statistical analysis. Blood pressure and RHR was measured with BpTRU® (Bp TRU medical devices, Coquitlam, Canada) on both occasions. All tests were performed using the same device and by the same researchers at the same time of the day both at baseline registration and at follow-up.
2. Glycosylated hemoglobin (HbA1c) was collected in EDTA blood. Serum for investigation of lipids (cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL) and C-reactive protein (CRP) was collected on gel tubes and then centrifuged 35 x 1000 rpm for 15 minutes within 60 minutes after the blood had been drawn from a vein. The tubes were sent by mail to the Department of Medical Biochemistry Oslo University Hospital and analyzed within 24 hours. HbA1c EDTA blood was analyzed with a Tosoh G7 HPLC analyser (Tosoh Bioscience, Inc., San Francisco, CA, USA) which uses "high performance liquid chromatography" as the separation principle. The analytical variation is 1.7 %.
3. Cholesterol, LDL and HDL in serum were analyzed by the enzymatic colorimetric method in the Cobas 8000. Analytical variation coefficients are respectively 3.0, 4.0 and 3.5 %.
4. CRP in serum was quantified by the particle enhanced immunoturbidimetric method on Cobas 8000 (Cobas 8000 Modular Analyzer Roche Diagnostics, www.roche.com). Analytical variation is 8.0 %.
Blood was collected at the same time of the day on both occasions.
|
|
Source(s) of Monetary Support
|
|
Statoil’s Fund for Research in Occupational Medicine
|
|
Ethics review
|
Status:
Approval date:
Contact:
Old ethics approval format; Regional Ethics Committee in Oslo (2014/1521), 04/12/2014, ref: 2014/1521/REK sør-øst B
|
|
Results
|
|
Results available:
|
Yes |
|
Date Posted:
|
|
|
Date Completed:
|
31/10/2015 |
|
URL:
|
|
|
|