Older Adults Exercising On Time

NCT06613958 | Completed

• 1 other identifier: NL82335.058.22
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia; Circadian Rhythm Disorders

Keywords

Chronoactivity; Sleep; Circadian rhythm; Exercise timing

Outcome Measures

Primary Outcomes (1)

• Insomnia severity

  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)'.

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

Secondary Outcomes (16)

• 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.

Study Arms (2)

Group 1

OTHER

Order of interventions: Sedentary - Active morning - Active Evening

Behavioral: Physical activity timing

Group 2

OTHER

Order of the interventions: Sedentary - Active Evening - Active Morning

Behavioral: Physical activity timing

Interventions

Physical activity timing BEHAVIORAL

The investigators will compare our interventions to a 14-day period of sedentary behavior, during which the participant will refrain from any moderate to vigorous exercise. Next, participants will participate in two interventions consisting each of a 14-day physical activity regimen. The active morning and active evening interventions are equal in content. Both groups will be instructed to refrain from any moderate to vigorous exercise for the rest of the day. Per intervention, a total of eight Vitality Club training session comprising of a combination of aerobic endurance training and resistance exercise training will be given by a trained sports coach or physical therapist specialized in geriatric physical therapy. During the weekends, participants will be asked to perform a 'relative rest' session with some light activity during the training time window of the intervention arm.

Also known as: Active morning (exercise program from 10:00 - 11:00 in the morning), Active evening (exercise program from 19:30 - 20:30 in the evening), Sedentary period (no exercise)

Group 1; Group 2

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Leiden University Medical Center: lead
• Netherlands Organisation of Scientific Research (NWO): collaborator
• Centre for Human Drug Research, Netherlands: collaborator
• Chrono@Work: collaborator
• Corsano Health B.V.: collaborator
• M-Path Leuven: collaborator

Study Sites (1)

Leiden University Medical Center

Leiden, South Holland, 2333ZA, Netherlands

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Chronobiology Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Diana van Heemst, PhD

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: September 26, 2024
• Study Start: May 2, 2024
• Primary Completion: June 27, 2024
• Study Completion: June 27, 2024
• Last Updated: September 26, 2024

Record last verified: 2024-09

Locations

NL (1)