NCT01609764

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 1, 2012

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

March 16, 2016

Status Verified

April 1, 2015

Enrollment Period

9 months

First QC Date

April 18, 2012

Last Update Submit

March 15, 2016

Conditions

Outcome Measures

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.

    At baseline and after 1 year

Secondary Outcomes (1)

  • Changes in quality sleep

    At baseline and after 1 year

Study Arms (2)

Exercise

EXPERIMENTAL

Follows the fitness program as described in the intervention

Behavioral: One year fitness training

Control

NO INTERVENTION

Will not follow any regular fitness activity during one year

Interventions

Regular training schedule of moderate intensity, at 50% of heart rate reserve, as available for the specific age group in fitness centres

Exercise

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University

Maastricht, Limburg, 6200 MD, Netherlands

Location

Related Publications (1)

  • 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.

Study Officials

  • Klaas R Westerterp, Professor

    Maastricht University, NUTRIM, Human biology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2012

First Posted

June 1, 2012

Study Start

January 1, 2013

Primary Completion

October 1, 2013

Study Completion

October 1, 2014

Last Updated

March 16, 2016

Record last verified: 2015-04

Locations