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CompletedNCT01609764Updated Mar 16, 2016

Physical Activity, Sleep and Age

An interventional study of One year fitness training in Aging, Movement Efficiency and Sleep, sponsored by Maastricht University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 50 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-03-16.

Sponsored by Maastricht University Medical Center · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
50 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Aging
  • Movement Efficiency
  • Sleep
03

In context

Lead sponsor

Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    Exercise

    Follows the fitness program as described in the intervention

    Behavioral: One year fitness training

  • No intervention
    Control

    Will not follow any regular fitness activity during one year

Interventions

  • BehavioralOne 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At baseline and after 1 year

Secondary outcomes

  1. 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.

    Time frame: At baseline and after 1 year

07

Study locations

1 site
  • Maastricht University
    Maastricht, Limburg 6200 MD, Netherlands
08

References and documents

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. PubMed 27268471 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01609764
Lead sponsor
Maastricht University Medical Center
Responsible party
Sponsor
First posted
Jun 1, 2012
Start date
Jan 2013
Primary completion
Oct 2013
Completion
Oct 2014
Last update
Mar 16, 2016

Study contacts

Klaas R Westerterp, Professor
principal investigator · Maastricht University, NUTRIM, Human biology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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