HEALTH AND EXERCISE IN THE DEFENSE FORCES

• ClinicalTrials.gov Identifier: NCT03539679
• Recruitment Status: Unknown
• First Posted: May 29, 2018
• Last Update Posted: September 12, 2019
• Sponsor: Tampere University Hospital
• Collaborators: Tampere University; University of Jyvaskyla; UKK Institute
• Information provided by (Responsible Party): Tampere University Hospital

Study Description

Brief 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. 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.

Condition or disease	Intervention/treatment	Phase
Physical Condition, Minor Psychological Component	Other: Encouraging physical activity.	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 500 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Intervention group and control group.
• Masking: Single (Participant)
• Masking Description: Exclusion criteria is that a volunteer must be health enough to have permission to take part in the military fitness tests.
• Primary Purpose: Other
• Official Title: TERVEYS JA LIIKUNTA PUOLUSTUSVOIMISSA
• Actual Study Start Date: May 16, 2018
• Estimated Primary Completion Date: December 2019
• Estimated Study Completion Date: July 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Encouraging physical activity; Encouraging physical activity by using motion sensor and feedback.	Other: Encouraging physical activity.; Encouraging physical activity with motion sensor's feedback.
No Intervention: CONTROL GROUP; No intervention.

Outcome Measures

Primary Outcome Measures :

1. Better physical condition. [ Time Frame: 6 months. ]
   12-minutes running test are measured.
2. Less sick leaves. [ Time Frame: From past 12 months up to next 12 months. ]
   The amount of sick leaves are measured.

Secondary Outcome Measures :

1. Positive changes in the TELI v 1.0 questionnaire. [ Time Frame: 6 months. ]
   Number of participants with better outcome in health habits (sleeping, eating, exercise).
2. Better physical condition. [ Time Frame: 6 months. ]
   Muscular fitness test.

Other Outcome Measures:

1. Better physical condition. [ Time Frame: 12 months. ]
   12-minutes running test are measured.
2. Better physical condition. [ Time Frame: 12 months. ]
   Muscular fitness test.
3. Positive changes in the TELI v 1.0 questionnaire. [ Time Frame: 12 months. ]
   Number of participants with better outcome in health habits (sleeping, eating, exercise).

Eligibility Criteria

• Ages Eligible for Study: 19 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Voluntaries armed forces workers.

Exclusion Criteria:

• Health enough to participate the military fitness test.

Contacts and Locations

Contacts

Contact: KAI I PARKKOLA, PROF EMER; +358 40 5003116; kai.parkkola@staff.uta.fi

Contact: HEIKKI KYRÖLÄINEN, PROF; +358 40 5408703; heikki.kyrolainen@jyu.fi

Locations

Finland

Kai Parkkola; Recruiting

Tampere, Finland, 33014

Principal Investigator: EMILIA PIETILÄINEN, MD

Sponsors and Collaborators

Tampere University Hospital

Tampere University

University of Jyvaskyla

UKK Institute

Investigators

• Study Director: KAI I PARKKOLA, PROF EMER; PROF EMER, UNIVERSITY OF TAMPERE
• Study Director: HEIKKI KYRÖLÄINEN, PROF; PROF, UNIVERSITY OF JYVÄSKYLÄ

More Information

• Responsible Party: Tampere University Hospital
• ClinicalTrials.gov Identifier: NCT03539679
• Other Study ID Numbers: R16189
• First Posted: May 29, 2018
• Last Update Posted: September 12, 2019
• Last Verified: September 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tampere University Hospital:

Exercise, sickness absences, health, military fitness