Physical Condition, Minor Psychological ComponentNCT03539679
HEALTH AND EXERCISE IN THE DEFENSE FORCES
A study testing Encouraging physical activity. in people with Physical Condition, Minor Psychological Component, run by Tampere University Hospital at 1 site in Finland.
Trial summary
The most important goal is to create a cost-effective, stimulating model for improving the employee's quality of life, work ability, and job satisfaction in the military operating environment. Read more about this study
- Who is it for?
- Ages 19 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Condition, Minor Psychological Component
- What is being tested?
- Encouraging physical activity.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteFinland
- Study dates
- 16 May 2018to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Voluntaries armed forces workers.
Who cannot join
- Health enough to participate the military fitness test.
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Kai Parkkola
Tampere, 33014
EMILIA PIETILÄINEN, MD
About this study
Official title: TERVEYS JA LIIKUNTA PUOLUSTUSVOIMISSA
The most important goal is to create a cost-effective, stimulating model for improving the employee's quality of life, work ability, and job satisfaction in the military operating environment. This is achieved by finding out how to activate an individual with the phone-based gaming and web-based feedback system to improve his physical condition. This study also tries to find out the adequate amount of physical activity to maintain the physical health of workers.
Personnel work ability, to work safe in service and effective operation capability of emergency forces require a worker's state of total well-being, in which the health and the physical condition are important parts. The changes in these affects the individual's fitness to military. This study develops a model to encourage an individual to carry out physical activity by himself. This will lead to reduce the sick leaves and improve the health and fitness.
Physical activity reduces morbidity. Professional soldiers must maintain their physical condition and skills. The study explores the optimum amount of working-age physical activity. It helps to maintain the working ability and one's fitness to field operations. With the help of the developed model it is possible cost-effectively activate a large number of employees to move more and to live more healthily.
Read the detailed description
In this study it will be used motion sensors which are sending feedback to individuals mobile phone. Feedback is also given by email and in an interview after analyzing data from cloud service.
In the beginning of the study it will analyzed blood test, salivary test, body composition, height weight and basic motion. All volunteers are also answering a questionnaire.
There will be an intervention group and a control group. The intervention group will receive feedback during the all six months they are carrying the motion sensor.
After 6 and 12 months the basic analyzes will be repeated. Sick leaves and the changes in the muscular fitness test and changes in the 12-minutes running test will be analyzed.
- Being tested
- Encouraging physical activity.
- Keywords
- Exercise, sickness absences, health, military fitness
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Encouraging physical activity.Other
Encouraging physical activity with motion sensor's feedback.
| Study group | Role | What they receive |
|---|---|---|
| Encouraging physical activity | Experimental | Encouraging physical activity by using motion sensor and feedback. Receives: Other: Encouraging physical activity. |
| CONTROL GROUP | No intervention | No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Better physical condition.
12-minutes running test are measured.
Measured: 6 months.
Less sick leaves.
The amount of sick leaves are measured.
Measured: From past 12 months up to next 12 months.
Secondary outcomes (2)
Positive changes in the TELI v 1.0 questionnaire.
Number of participants with better outcome in health habits (sleeping, eating, exercise).
Measured: 6 months.
Better physical condition.
Muscular fitness test.
Measured: 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start16 May 2018
- Primary completionDec 2019 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical Condition, Minor Psychological ComponentStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention group and control group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University, University of Jyvaskyla, UKK Institute
- Responsible party
- Sponsor
- Investigators
- KAI I PARKKOLA, PROF EMER, Study director, PROF EMER, UNIVERSITY OF TAMPEREHEIKKI KYRÖLÄINEN, PROF, Study director, PROF, UNIVERSITY OF JYVÄSKYLÄ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03539679
- Sponsor's protocol ID
- R16189
- Status last verified
- Sep 2019
- First submitted
- 25 Apr 2018
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TERVEYS JA LIIKUNTA PUOLUSTUSVOIMISSA
- ClinicalTrials.gov ID
- NCT03539679
- Acronym / sponsor ID
- R16189
- Keywords
- Exercise, sickness absences, health, military fitness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Tampere University, University of Jyvaskyla, UKK Institute
- Study start
- 16 May 2018 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 29 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The most important goal is to create a cost-effective, stimulating model for improving the employee's quality of life, work ability, and job satisfaction in the military operating environment. This is achieved by finding out how to activate an individual with the phone-based gaming and web-based feedback system to improve his physical condition. This study also tries to find out the adequate amount of physical activity to maintain the physical health of workers.
Personnel work ability, to work safe in service and effective operation capability of emergency forces require a worker's state of total well-being, in which the health and the physical condition are important parts. The changes in these affects the individual's fitness to military. This study develops a model to encourage an individual to carry out physical activity by himself. This will lead to reduce the sick leaves and improve the health and fitness.
Physical activity reduces morbidity. Professional soldiers must maintain their physical condition and skills. The study explores the optimum amount of working-age physical activity. It helps to maintain the working ability and one's fitness to field operations. With the help of the developed model it is possible cost-effectively activate a large number of employees to move more and to live more healthily.
Detailed description
In this study it will be used motion sensors which are sending feedback to individuals mobile phone. Feedback is also given by email and in an interview after analyzing data from cloud service.
In the beginning of the study it will analyzed blood test, salivary test, body composition, height weight and basic motion. All volunteers are also answering a questionnaire.
There will be an intervention group and a control group. The intervention group will receive feedback during the all six months they are carrying the motion sensor.
After 6 and 12 months the basic analyzes will be repeated. Sick leaves and the changes in the muscular fitness test and changes in the 12-minutes running test will be analyzed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Intervention group and control group.
| Arm | Type | Receives |
|---|---|---|
| Encouraging physical activity | Experimental | Other: Encouraging physical activity.Encouraging physical activity by using motion sensor and feedback. |
| CONTROL GROUP | No intervention | –No intervention. |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Voluntaries armed forces workers.
Key exclusion criteria (1 listed)
- Health enough to participate the military fitness test.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Encouraging physical activity.Encouraging physical activity with motion sensor's feedback. | Other | Encouraging physical activity |
Primary outcome
Better physical condition.
Time frame: 6 months.
12-minutes running test are measured.
Less sick leaves.
Time frame: From past 12 months up to next 12 months.
The amount of sick leaves are measured.
2 secondary outcomes
Positive changes in the TELI v 1.0 questionnaire.
Time frame: 6 months.
Better physical condition.
Time frame: 6 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
KAI I PARKKOLA, PROF EMER study director
PROF EMER, UNIVERSITY OF TAMPERE
HEIKKI KYRÖLÄINEN, PROF study director
PROF, UNIVERSITY OF JYVÄSKYLÄ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Encouraging physical activity. in people with Physical Condition, Minor Psychological Component, run by Tampere University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact KAI I PARKKOLA, PROF EMER (+358 40 5003116, kai.parkkola@staff.uta.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Better physical condition. (time frame: 6 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2019.