Physical Activity, Sleep and Age

Aging Clinical Trial

Official title:

Physical Activity and Movement Efficiency and Quality Sleep With Increasing Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01609764
• Other study ID #: NL40040.068.12
• Status: Completed
• Phase: N/A
• First received: April 18, 2012
• Last updated: March 15, 2016
• Start date: January 2013
• Est. completion date: October 2014

Study information

• Verified date: April 2015
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: October 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Aging
• Movement Efficiency
• Sleep

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

Locations

Country	Name	City	State
Netherlands	Maastricht University	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	At baseline and after 1 year	No