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Physical Activity, Sleep and Age

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01609764
First Posted: June 1, 2012
Last Update Posted: March 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Maastricht University Medical Center
  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

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Physical Activity and Movement Efficiency and Quality Sleep With Increasing Age

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Changes in movement efficiency [ Time Frame: At baseline and after 1 year ]

    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 quality sleep [ Time Frame: At baseline and after 1 year ]

    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.



Enrollment: 45
Study Start Date: January 2013
Study Completion Date: October 2014
Primary Completion Date: October 2013 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01609764


Locations
Netherlands
Maastricht University
Maastricht, Limburg, Netherlands, 6200 MD
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Klaas R Westerterp, Professor Maastricht University, NUTRIM, Human biology
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01609764     History of Changes
Other Study ID Numbers: NL40040.068.12
First Submitted: April 18, 2012
First Posted: June 1, 2012
Last Update Posted: March 16, 2016
Last Verified: April 2015