Clinical trial NCT06613958: Older Adults Exercising On Time
Official title: Older Adults Exercising On Time
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Circadian Rhythm Disorders
Keywords: Chronoactivity
Sleep
Circadian rhythm
Exercise timing
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Netherlands Organisation of Scientific Research (NWO)
name: Centre for Human Drug Research, Netherlands
name: Chrono@Work
name: Corsano Health B.V.
name: M-Path Leuven
First posted: 2024-09-26
Enrollment: 36
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The investigators will perform a randomized two-armed cross-over study. Both groups will start with the sedentary period. Depending on the intervention arm, participants will then undergo the active morning intervention or active evening intervention first, followed by the other intervention. There will be a total of two washout periods both lasting 7 days, one between the sedentary period and first intervention and one between the first and second intervention to prevent or minimize 'carry over' of previous intervention effect. The two interventions and the sedentary period will last 14 days each and contain a 'calibration period' (7 days) and a 'measurement week' (7 days). The total study duration will be 8 weeks and the study will largely take place at the participants' home except for the training sessions (Vitality Clubs) that will take place at an outdoor sports facility in the municipality of Leiden and the study site visits which will take place in the LUMC.
Primary purpose: BASIC_SCIENCE

Brief summary: There are indications from 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, the investigators 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, the investigators 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. To study this research hypothesis, the investigators will examine the effect of physical activity timing on insomnia severity in older adults with self-reported sleep problems. In addition, the investigators will 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. For this study, a two-armed randomised cross-over study, Dutch speaking older adults between 60 and 80 years old (male and female) and having sleep problems (insomnia severity index\>10 points) from the general population in the Netherlands will be selected as participants for this study. Participants will perform 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 rest days 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. Study outcomes will be compared between the different intervention groups.


Eligibility criteria: 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
* Extreme sleep chronotypes (measured by the Munich chronotype questionnaire)
* 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 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

Primary outcomes:
measure: Insomnia severity
timeFrame: 4 times in total: at baseline T-3 (T= week), at T2 , T5, and at T8 (endline).
Secondary outcomes:
measure: Dim light melatonin onset (DLMO)
timeFrame: 3 times in total: two weeks, five weeks and eight weeks after baseline.
measure: Ecological monitoring assessment
timeFrame: 3 periods in total of one week each: the second week, the fifth week and the eighth week.
measure: Sleep quality - sleep duration
timeFrame: 3 periods in total of 2 weeks each: weeks 1-2 , weeks 4-5, and weeks 7-8.
measure: Sleep quality - sleep latency
timeFrame: 3 periods in total of 2 weeks each: weeks 1-2 , weeks 4-5, and weeks 7-8.
measure: Sleep quality - sleep stages
timeFrame: 3 periods in total of 2 weeks each: weeks 1-2 , weeks 4-5, and weeks 7-8.
measure: Sleep quality - sleep efficiency
timeFrame: 3 periods in total of 2 weeks each: weeks 1-2 , weeks 4-5, and weeks 7-8.
measure: Sleep quality - sleep regularity
timeFrame: 3 periods in total of 2 weeks each: weeks 1-2 , weeks 4-5, and weeks 7-8.
measure: Biological assessment: clock gene expression
timeFrame: 4 times in total: at baseline (3 weeks before start of the study), at the second , fifth, and eighth week
measure: Biological assessment: metabolomics
timeFrame: 4 times in total: at baseline (3 weeks before start of the study), at the second , fifth, and eighth week
measure: Biological assessment: proteomics
timeFrame: 4 times in total: at baseline (3 weeks before start of the study), at the second , fifth, and eighth week
measure: Biological assessment: glucose metabolism
timeFrame: 4 times in total: at baseline (3 weeks before start of the study), at the second , fifth, and eighth week
measure: Biological assessment: biomarkers for inflammation, thyroid, kidney and liver function
timeFrame: 4 times in total: at baseline (3 weeks before start of the study), at the second , fifth, and eighth week
measure: Food capturing
timeFrame: 3 periods in total of one week each: week two, week five, and at week eight.
measure: Heart rate
timeFrame: 3 periods in total of 2 weeks each: weeks 1-2 , weeks 4-5, and weeks 7-8.
measure: Heart rate variability
timeFrame: 3 periods in total of 2 weeks each: weeks 1-2 , weeks 4-5, and weeks 7-8.
measure: Core body temperature
timeFrame: 3 periods in total of 2 weeks each: weeks 1-2 , weeks 4-5, and weeks 7-8.
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
state: Zuid-Holland
Study officials:
affiliation: Leiden University Medical Center
name: Diana van Heemst, PhD
role: PRINCIPAL_INVESTIGATOR
References: