Primary:To examine the effect of physical activity timing on insomnia severity in older adults with self-reported sleep problems.Secondary:To examine the effect of physical activity timing on exploratory rhythmic parameters of biological clock…
ID
Source
Brief title
Condition
- Sleep disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome of this study will be insomnia severity which will be measured
by the Dutch version of the ISI ranging from 0-28 (0-7: no clinically
significant insomnia; 8-14: subthreshold insomnia; 15-21: moderate severity
clinical insomnia; 22-28: severe clinical insomnia).
Secondary outcome
Secondary and exploratory endpoints include:
Biological clock function
• Clockgene expression
• Core body temperature (°C)
o Diurnal pattern
o Time of lowest temperature
• Melatonin
o Dim light melatonin onset (DLMO)
Physiological parameters
• Heart rate
o Diurnal pattern
o Average
o Resting heart rate
o Minimum/peak heart rate (5 and 95 percentile)
• Heart rate variability (HRV)
• Breathing rate
• Oxygen saturation (SpO2)
Mental health
• Subjective mood
o Diurnal pattern of:
* Positive affectivity
* Negative affectivity
* Energy
* Fatigue
* Cognition
• (objective) Electrodermal activity (emotional arousal and stress)
Behavioural factors
• Food intake
o Frequency
o Timing
• Habitual sleep (Table 8.1)
o Sleep latency (min)
o Duration (min)
o Efficiency (%)
o Sleep phases (%, min)
o Awakenings at night (x, min)
o Rested feeling (subjective, 0-7)
o General satisfaction with sleep (subjective, 0-7)
Biochemistry
• Glucose metabolism*
• Inflammatory markers
• Liver function
• Kidney function
• Thyroid function
• White blood cell count
Background summary
There are indications based on epidemiological cohort studies and animal
experiments that timing of physical activity (also referred as
*chronoactivity*), irrespective of intensity, impacts health and disease. In
view of the detrimental effects of circadian misalignment, the large group of
older people suffering from sleep problems, and the seeming importance of
chronoactivity, we will perform a randomised cross-over study that aims to
uncover the effect of timing of physical activity on insomnia severity and
related (circadian) health parameters in older adults with self-reported sleep
problems. Here, we hypothesize that timing of physical activity has a
beneficial impact on insomnia symptoms and on circadian rhythms of additional
health parameters (e.g., metabolic, psychosocial) in older people.
Study objective
Primary:
To examine the effect of physical activity timing on insomnia severity in older
adults with self-reported sleep problems.
Secondary:
To examine the effect of physical activity timing on exploratory rhythmic
parameters of biological clock function, physiology and metabolism, mental
health, behavioural factors, and immune and cell signalling functions.
Study design
This study will be a two-armed randomised cross-over study. This means that all
participants will go through all interventions.
Intervention
The intervention will comprise one sedentary period and two period of increased
physical activity with different daily patterns: 1) active morning; 2) active
evening with a duration of 14 days each. In both active intervention arms,
participants will follow an exercise program containing outdoor physical
exercise sessions (Vitality Club) containing endurance and strength exercises,
relative restdays of 30 minutes light intensity physical activity, and one
Active@Home program; a 1-hour training session of various moderate to vigorous
activities. The training sessions will be held either in the morning or evening
(depending on the intervention arm) and will be one hour long. Since this will
be a cross-over study, all participants will follow the sedentary period as
well as both exercise timing interventions consecutively with a 7-day wash-out
period between all interventions.
Study burden and risks
The chance of harm is small, because it is largely non-invasive research. The 5
blood draws are the only invasive procedures of the study. The procedures
performed in this study are frequently performed in clinical practice and
clinical research. In addition, the exercise interventions are supervised by a
physiotherapist specialized in elderly care. There is therefore a lot of
experience with the risks and possible adverse effects of the intervention and
all other procedures. For this reason, there is great predictability that risks
are negligible.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
• Aged between 60 and 80 years old
• Retired
• Long lasting sleep problems (as assessed by a the screening questionnaire
administered telephonically and by the ISI which will be filled out during the
screening visit)
• Access to and ability to use a smart phone (Android or Apple)
Exclusion criteria
• Currently employed or working
• Participation in any sort of fasting regimen (e.g. intermitted fasting or
Ramadan)
• Experienced recent (<6 months) adverse life events (e.g., death of partner)
• Abnormal/extreme values in glucose metabolism, thyroid, liver or kidney
function, or inflammation markers that after examination of the study doctor
need immediate attention of a general practitioner or specialist.
• Diagnosed clinical depression
• Diagnosed neurodegenerative diseases (e.g. dementia or Parkinson*s disease)
• Diagnosed sleep apnoea
• Diagnosed restless legs syndrome
• Use of beta-adrenergic blocking agents
• Use of sleep medication
• Injuries or other severe physical conditions (such as active arthrosis) that
inhibits physical activity
• Travelled across time zones one week prior to start of study
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 |
|---|---|
| CCMO | NL82335.058.22 |