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Clinical Trials/NCT06613958
NCT06613958
Completed
Not Applicable

Older Adults Exercising On Time

Leiden University Medical Center1 site in 1 country36 target enrollmentMay 2, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Insomnia
Sponsor
Leiden University Medical Center
Enrollment
36
Locations
1
Primary Endpoint
Insomnia severity
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2, 2024
End Date
June 27, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Leiden University Medical Center
Responsible Party
Principal Investigator
Principal Investigator

dvanheemst

Principal investigator

Leiden University Medical Center

Eligibility Criteria

Inclusion Criteria

  • Aged between 60 and 80 years old
  • 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

Outcomes

Primary Outcomes

Insomnia severity

Time Frame: 4 times in total: at baseline T-3 (T= week), at T2 , T5, and at T8 (endline).

Score on Insomnia Severity Index (ISI). Participants will be asked to fill out the ISI questionnaire (Dutch version) The ISI questionnaire consists of 7 questions and outcomes include: 'No clinically significant insomnia (0-7 points)', 'Subthreshold insomnia (8-14 points)', 'Moderate severity clinical insomnia (15-21 point), and 'Severe clinical insomnia (22-28 points)'.

Secondary Outcomes

  • Dim light melatonin onset (DLMO)(3 times in total: two weeks, five weeks and eight weeks after baseline.)
  • Ecological monitoring assessment(3 periods in total of one week each: the second week, the fifth week and the eighth week.)
  • Sleep quality - sleep duration(3 periods in total of 2 weeks each: weeks 1-2 , weeks 4-5, and weeks 7-8.)
  • Sleep quality - sleep latency(3 periods in total of 2 weeks each: weeks 1-2 , weeks 4-5, and weeks 7-8.)
  • Sleep quality - sleep stages(3 periods in total of 2 weeks each: weeks 1-2 , weeks 4-5, and weeks 7-8.)
  • Sleep quality - sleep efficiency(3 periods in total of 2 weeks each: weeks 1-2 , weeks 4-5, and weeks 7-8.)
  • Sleep quality - sleep regularity(3 periods in total of 2 weeks each: weeks 1-2 , weeks 4-5, and weeks 7-8.)
  • Biological assessment: clock gene expression(4 times in total: at baseline (3 weeks before start of the study), at the second , fifth, and eighth week)
  • Biological assessment: metabolomics(4 times in total: at baseline (3 weeks before start of the study), at the second , fifth, and eighth week)
  • Biological assessment: proteomics(4 times in total: at baseline (3 weeks before start of the study), at the second , fifth, and eighth week)
  • Biological assessment: glucose metabolism(4 times in total: at baseline (3 weeks before start of the study), at the second , fifth, and eighth week)
  • Biological assessment: biomarkers for inflammation, thyroid, kidney and liver function(4 times in total: at baseline (3 weeks before start of the study), at the second , fifth, and eighth week)
  • Food capturing(3 periods in total of one week each: week two, week five, and at week eight.)
  • Heart rate(3 periods in total of 2 weeks each: weeks 1-2 , weeks 4-5, and weeks 7-8.)
  • Heart rate variability(3 periods in total of 2 weeks each: weeks 1-2 , weeks 4-5, and weeks 7-8.)
  • Core body temperature(3 periods in total of 2 weeks each: weeks 1-2 , weeks 4-5, and weeks 7-8.)

Study Sites (1)

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