Physical Activity, Health and Age

This study is not yet open for participant recruitment.
Verified June 2012 by Maastricht University Medical Center
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01609764
First received: April 18, 2012
Last updated: June 11, 2012
Last verified: June 2012
  Purpose

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:

  1. Laboratory validation test of body acceleration based indexes for movement efficiency and quality of sleep;
  2. Cross-sectional analysis to assess relations between these indexes and age;
  3. Intervention study to assess the effect of exercise training on daily life movement efficiency and quality of sleep in ageing subjects

The population will be composed of 100 healthy human volunteers, age 45-85 yr, BMI 20-30 kg/m2, 25 subjects in each decade. Twenty subjects, five per decade, will be part of a control group. Subjects that will have practiced fitness activities in the previous year, as well as pregnant or lactating women, will be excluded.


Condition Intervention
Aging
Movement Efficiency
Sleep
Behavioral: One year fitness training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Physical Activity and Movement Efficiency and Quality of Sleep With Increasing Age

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Changes in daily life movement efficiency [ Time Frame: Baseline, at 6 months and after 1 year ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Changes in daily life quality of sleep [ Time Frame: Baseline, at 6 months and after 1 year ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 100
Study Start Date: July 2012
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise
Follows the fitness program as described in the intervention
Behavioral: One year fitness training
Regular training schedule of moderate intensity, at 50% of heart rate reserve, as available for the specific age group in fitness centres
No Intervention: Control
Will not follow any regular fitness activity during one year

  Eligibility

Ages Eligible for Study:   45 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women
  • Age between 45-85 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 45 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01609764

Contacts
Contact: Giulio Valenti, drs +31(0)4338 82 124 g.valenti@maastrichtuniversity.nl

Locations
Netherlands
Maastricht University Not yet recruiting
Maastricht, Limburg, Netherlands, 6200 MD
Sub-Investigator: Giulio Valenti, drs         
Principal Investigator: Klaas R Westerterp, Professor         
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Klaas R Westerterp, Professor Maastricht University, NUTRIM, Human biology
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01609764     History of Changes
Other Study ID Numbers: NL40040.068.12
Study First Received: April 18, 2012
Last Updated: June 11, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

ClinicalTrials.gov processed this record on April 23, 2014