AgingNCT01609764
Physical Activity, Sleep and Age
A study testing One year fitness training in people with Aging and Movement Efficiency, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Movement Efficiency, Sleep
- What is being tested?
- One year fitness training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2013to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical Activity and Movement Efficiency and Quality Sleep With Increasing Age
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:
Read more
- Laboratory validation test of body acceleration based indexes for movement efficiency and quality of sleep;
- Cross-sectional analysis to assess relations between these indexes and age;
- 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.
- Conditions
- Aging, Movement Efficiency, Sleep
- Being tested
- One year fitness training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One year fitness trainingBehavioural
Regular training schedule of moderate intensity, at 50% of heart rate reserve, as available for the specific age group in fitness centres
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Follows the fitness program as described in the intervention Receives: Behavioral: One year fitness training |
| Control | No intervention | Will not follow any regular fitness activity during one year |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At baseline and after 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2012 (estimated)
- Study startJan 2013
- Primary completionOct 2013
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Klaas R Westerterp, Professor, Principal investigator, Maastricht University, NUTRIM, Human biology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01609764
- Sponsor's protocol ID
- NL40040.068.12
- Status last verified
- Apr 2015
- First submitted
- 18 Apr 2012
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity and Movement Efficiency and Quality Sleep With Increasing Age
- ClinicalTrials.gov ID
- NCT01609764
- Acronym / sponsor ID
- NL40040.068.12
- Conditions
- Aging, Movement Efficiency, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 1 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Laboratory validation test of body acceleration based indexes for movement efficiency and quality of sleep;
- Cross-sectional analysis to assess relations between these indexes and age;
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: One year fitness trainingFollows the fitness program as described in the intervention |
| Control | No intervention | –Will not follow any regular fitness activity during one year |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One year fitness trainingRegular training schedule of moderate intensity, at 50% of heart rate reserve, as available for the specific age group in fitness centres | Behavioural | Exercise |
Primary outcome
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.
1 secondary outcome
Changes in quality sleep
Time frame: At baseline and after 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
- Derived from this study: PubMed 27268471Valenti 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaas R Westerterp, Professor principal investigator
Maastricht University, NUTRIM, Human biology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One year fitness training in people with Aging and Movement Efficiency, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in movement efficiency (time frame: At baseline and after 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01609764, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2016.