## Protocol Section
### Identification Module
**NCT ID:** NCT03539679

**Brief Title:** HEALTH AND EXERCISE IN THE DEFENSE FORCES

**Official Title:** TERVEYS JA LIIKUNTA PUOLUSTUSVOIMISSA

#### Organization Study ID Info
**ID:** R16189
#### Organization
**Class:** OTHER
**Full Name:** Tampere University Hospital
### Status Module
#### Completion Date
**Date:** 2020-07

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2019-09-12

**Type:** ACTUAL

**Last Update Submit Date:** 2019-09-11

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2019-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2018-05-16

**Type:** ACTUAL

**Status Verified Date:** 2019-09

#### Study First Post Date
**Date:** 2018-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2018-04-25
**Study First Submit QC Date:** 2018-05-16
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Tampere University

**Class:** OTHER

**Name:** University of Jyvaskyla

**Class:** OTHER

**Name:** UKK Institute

#### Lead Sponsor

**Class:** OTHER

**Name:** Tampere University Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

**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.

### Conditions Module

**Conditions:**

- Physical Condition, Minor Psychological Component

**Keywords:**

- Exercise, sickness absences, health, military fitness

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Intervention group and control group.

##### Masking Info

**Masking:** SINGLE

**Masking Description:** Exclusion criteria is that a volunteer must be health enough to have permission to take part in the military fitness tests.

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 500

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Encouraging physical activity by using motion sensor and feedback.

**Intervention Names:**

- Other: Encouraging physical activity.

**Label:** Encouraging physical activity

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** No intervention.

**Label:** CONTROL GROUP

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Encouraging physical activity

**Description:** Encouraging physical activity with motion sensor's feedback.

**Name:** Encouraging physical activity.

**Type:** OTHER

### Outcomes Module

#### Other Outcomes

**Description:** 12-minutes running test are measured.

**Measure:** Better physical condition.

**Time Frame:** 12 months.

**Description:** Muscular fitness test.

**Measure:** Better physical condition.

**Time Frame:** 12 months.

**Description:** Number of participants with better outcome in health habits (sleeping, eating, exercise).

**Measure:** Positive changes in the TELI v 1.0 questionnaire.

**Time Frame:** 12 months.

#### Primary Outcomes

**Description:** 12-minutes running test are measured.

**Measure:** Better physical condition.

**Time Frame:** 6 months.

**Description:** The amount of sick leaves are measured.

**Measure:** Less sick leaves.

**Time Frame:** From past 12 months up to next 12 months.

#### Secondary Outcomes

**Description:** Number of participants with better outcome in health habits (sleeping, eating, exercise).

**Measure:** Positive changes in the TELI v 1.0 questionnaire.

**Time Frame:** 6 months.

**Description:** Muscular fitness test.

**Measure:** Better physical condition.

**Time Frame:** 6 months.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Voluntaries armed forces workers.

Exclusion Criteria:

* Health enough to participate the military fitness test.

**Healthy Volunteers:** True

**Maximum Age:** 60 Years

**Minimum Age:** 19 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** kai.parkkola@staff.uta.fi

**Name:** KAI I PARKKOLA, PROF EMER

**Phone:** +358 40 5003116

**Role:** CONTACT

**Contact 2:**

**Email:** heikki.kyrolainen@jyu.fi

**Name:** HEIKKI KYRÖLÄINEN, PROF

**Phone:** +358 40 5408703

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Tampere

**Contacts:**

***Contact 1:***

- **Name:** EMILIA PIETILÄINEN, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Finland

**Facility:** Kai Parkkola

**Status:** RECRUITING

**Zip:** 33014

#### Overall Officials

**Official 1:**

**Affiliation:** PROF EMER, UNIVERSITY OF TAMPERE

**Name:** KAI I PARKKOLA, PROF EMER

**Role:** STUDY_DIRECTOR

**Official 2:**

**Affiliation:** PROF, UNIVERSITY OF JYVÄSKYLÄ

**Name:** HEIKKI KYRÖLÄINEN, PROF

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
