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Physical Activity, Sleep and Age

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ClinicalTrials.gov Identifier: NCT01609764
Recruitment Status : Completed
First Posted : June 1, 2012
Last Update Posted : March 16, 2016
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Tracking Information
First Submitted Date  ICMJE April 18, 2012
First Posted Date  ICMJE June 1, 2012
Last Update Posted Date March 16, 2016
Study Start Date  ICMJE January 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 31, 2012)
Changes in quality of movement index [ Time Frame: Baseline, at 6 months and after 1 year ]
The first objective is to identify acceleration features to be included in an index able to describe quality of movement. Secondarily we will relate this index with age in order to understand how ageing affects quality of movement. Our third objective is to show the effects of regular physical activity training on this index. The expected improvements would show that the intervention, consisting in a training schedule of aerobic exercise, is able to reduce the age effect on quality of movement.
Change History Complete list of historical versions of study NCT01609764 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2016)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2012)
Changes in quality of sleep index [ Time Frame: Baseline, at 6 months and after 1 year ]
The first objective is to identify acceleration features to be included in an index able to describe quality of sleep. Secondarily we will relate this index with age in order to understand how ageing affects quality of sleep. Our third objective is to show the effects of regular physical activity training on this index. The expected improvements would show that the intervention, consisting in a training schedule of aerobic exercise, is able to reduce the age effect on quality of sleep.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Physical Activity, Sleep and Age
Official Title  ICMJE Physical Activity and Movement Efficiency and Quality Sleep With Increasing Age
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:

  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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Aging
  • Movement Efficiency
  • Sleep
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: Exercise
    Follows the fitness program as described in the intervention
    Intervention: Behavioral: One year fitness training
  • No Intervention: Control
    Will not follow any regular fitness activity during one year
Publications * Valenti G, Bonomi AG, Westerterp KR. Walking as a Contributor to Physical Activity in Healthy Older Adults: 2 Week Longitudinal Study Using Accelerometry and the Doubly Labeled Water Method. JMIR Mhealth Uhealth. 2016 Jun 7;4(2):e56. doi: 10.2196/mhealth.5445.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 15, 2016)
45
Original Estimated Enrollment  ICMJE
 (submitted: May 31, 2012)
100
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01609764
Other Study ID Numbers  ICMJE NL40040.068.12
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Maastricht University Medical Center
Study Sponsor  ICMJE Maastricht University Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Klaas R Westerterp, Professor Maastricht University, NUTRIM, Human biology
PRS Account Maastricht University Medical Center
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP