- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01609764
Physical Activity, Sleep and Age
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:
- 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Limburg
-
Maastricht, Limburg, Nederländerna, 6200 MD
- Maastricht University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Faktoriell uppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Exercise
Follows the fitness program as described in the intervention
|
Regular training schedule of moderate intensity, at 50% of heart rate reserve, as available for the specific age group in fitness centres
|
Inget ingripande: Control
Will not follow any regular fitness activity during one year
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Changes in movement efficiency
Tidsram: 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. |
At baseline and after 1 year
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Changes in quality sleep
Tidsram: At baseline and after 1 year
|
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
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Klaas R Westerterp, Professor, Maastricht University, NUTRIM, Human biology
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- NL40040.068.12
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