Physical Activity, Sleep and Age

Study Overview
=================
Brief Summary
-----------------
Ageing is associated with a reduction of physical activity, movement efficiency, and quality of sleep. This leads to reduced health and well being in elderly subjects. Exercise training can increase movement efficiency and quality of sleep. Objectives: Laboratory validation test of body acceleration based indexes for movement efficiency and quality of sleep; Cross-sectional analysis to assess relations between these indexes and age; Intervention study to assess the effect of exercise training on daily life movement efficiency and quality of sleep in ageing subjects 45 healthy human volunteers, age 50-83 yr, BMI 20-30 kg/m2 are divided in control or intervention group. Subjects that will have practiced fitness activities in the previous year, as well as pregnant or lactating women, will be excluded.

Official Title
-----------------
Physical Activity and Movement Efficiency and Quality Sleep With Increasing Age

Conditions
-----------------
Aging, Movement Efficiency, Sleep

Intervention / Treatment
-----------------
* Behavioral: One year fitness training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women Age between 50-85 years No fitness activity in the previous year, to amplify training effects on movement efficiency and quality of sleep. Body mass index between 20 and 30 kg/m2, obesity limits the training capacity of subjects. Signed informed consent by the participants Exclusion Criteria: Age below 50 or above 85 years; body mass index below 20 kg/m2 or above 30 kg/m2; neurologic, cardiologic or invalidating orthopaedic disease; pregnancy or lactation.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>Follows the fitness program as described in the intervention | Behavioral: One year fitness training<br>* Regular training schedule of moderate intensity, at 50% of heart rate reserve, as available for the specific age group in fitness centres<br>|
| No Intervention: Control<br>Will not follow any regular fitness activity during one year | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in movement efficiency | The primary objective is to identify features of body acceleration to be included in an index to assess daily life movement efficiency. Secondly, the index is related with age to quantify how ageing affects daily life movement efficiency. The third objective is to show the effects of regular physical activity training on this index. The expected improvement of the index would show that exercise delays the age related decrease of movement efficiency. | At baseline and after 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in quality sleep | The primary objective is to identify features of body acceleration to be included in one index to assess quality of sleep in daily life. Secondly, the index is related with age to quantify how ageing affects quality of sleep. The third objective is to show the effects of regular physical activity training on this index. The expected improvement of the index would show that exercise delays the age related decrease of quality of sleep. | At baseline and after 1 year |