To assess the effect of fitness training on movement efficiency, fitness level, physical activity and quality of sleep in ageing subjects
ID
Source
Brief title
Condition
- Age related factors
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Movement efficiency . Movement efficiency is derived from activity energy
expenditure during specific activities at a fixed workload, measured with
indirect calorimetry.
Secondary outcome
Fitness level, as derived by indirect calorimetry during maximal exercise,
measured at the beginning and at the end of the intervention in order to
determine the effect of fitness training.
Physical activity, as derived by accelerometry during 2 weeks in daily life,
measured at the beginning, after six months and at the end of the intervention
in order to determine the effect of fitness training.
Quality of sleep, as assessed with a polysomnogram and by comparing deep sleep
energy expenditure to overnight energy expenditure during one night in a
respiration chamber, measured at the beginning and at the end of the
intervention in order to determine the effect of fitness training.
Background summary
Ageing is associated with a reduction of movement efficiency, fitness level,
physical activity and quality of sleep. This leads to reduced health and well
being in elderly subjects. Fitness training can increase movement efficiency,
fitness level, physical activity and quality of sleep.
Study objective
To assess the effect of fitness training on movement efficiency, fitness level,
physical activity and quality of sleep in ageing subjects
Study design
The study consists of an intervention study on the efficacy of fitness training
on movement efficiency fitness level, physical activity and and quality of
sleep.
Intervention
Subjects in the intervention group will have subscribed for a group fitness
training schedule of moderate intensity, at 50% of heart rate reserve, as
available for the specific age group in a fitness centre (Topfit, Maastricht).
Control subjects are not interested in subscribing to any fitness program
during the study.
Study burden and risks
Subjects interested in the study will receive the information letter and a copy
of the informed consent and they will be given at least one week to decide
whether to participate. Subjects that decide to participate and signed the
informed consent will visit the university four times: a screening visit (1
hour) a visit to assess fitness level (1 hour) and two visits to perform
initial and final measurements (11 and 13 hours respectively).
During the screening visit, (1 hour) subjects will visit our physician. The
visit will include an ECG (examined by a cardiologist), blood pressure and
auscultation (0.5 hours), an anamnesis to be recorded in a questionnaire
concerning personal and family health condition, personal lifestyle and
measurements of height, weight and body composition (0.5 hours). Fitness level
is assessed during the second and the fourth visit with maximal oxygen
consumption as measured on a cycle ergometer (1 hour each). The visit for
initial measurements at the university includes, movement efficiency, i.e.
energy expenditure during four standardised activities (1 hour), and the
assessment of sleep quality with polysomnography in a respiration chamber (10
hours overnight). Measurements of body characteristics, fitness level (maximal
test), movement efficiency, and sleep quality will be repeated during the final
visit. Subjects from both groups will wear a tri-axial accelerometer for
movement registration (DirectLife active monitor) for two weeks at baseline,
after 6 months and after 12 months. A diary will be used to report when one
gets up in the morning, goes to bed at night, and to report periods when not
wearing the device during the day.
There are no risks associated with the tests and measurements, except for the
maximal test. This test can cause fatigue. The medical screening will minimize
risks of injuries. Participation to the training is a requisite for the
participation as intervention subject. Risks of injuries during this training
will be also minimized by the supervision during all sessions by a training
instructor.
Subjects will receive 40 euro for every night spent at the university, 30 euro
for every assessment of fitness level, and 10 euro for each measurement of
movement efficiency (40 ¤ * 2 + 30 ¤ * 2 + 10 ¤ * 2 = 160 ¤). Transport
allowances will also be provided to both groups for each visit.
Universiteitssingel 50
Maastricht 6229 ER
NL
Universiteitssingel 50
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
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 years;
Body mass index below 20 kg/m2 or above 30 kg/m2;
Cardiologic issues (Cardiac insufficiency, myocardial infection, angina pectoris, hyper- hypotension), orthopaedic issues (arthrosis, prosthesis or reduced functionality of lower limbs) or neurologic diseases (Alzheimer, Parkinson, epilepsy, history of strokes) as evaluated by our physician. If any abnormality is revealed, our physician will evaluate the possibility of inclusion. An ECG at rest will be screend by a researcher experienced in reading ECG*s. In case of any abnormal reading in the ECG the subject will be excluded. Both the subject and his general practitioner will be informed in case of health issues, with the agreement of the subject (informed consent);
Pregnancy or lactation.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01609764 |
| CCMO | NL41052.068.12 |