EPOCH: Effects of Physical Exercise Timing On Strength and Cardiometabolic Health

• Sponsor: University of Basel (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06063135
• Collaborator: (none)
• Enrollment: 105
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 30.9
• Patients Per Site Per Month: 3.4

Study Details

Study Description

Brief Summary

Physical exercise is well known to improve human health. Current guidelines provide recommendations on the frequency, intensity, type and duration of exercise. However, they do not provide recommendations for the time of day, exercise should be performed. This is surprising considering that the influence of timing of behaviors such as sleep or nutrition as well as the impact of the circadian timing system on health are well documented. Further, there is evidence for diurnal variation in maximum performance which enables individuals to exercise with different intensities at different times of day, which in the long term might affect physical adaptations to exercise. Thus, this research study investigates if exercise timing impacts human health.

Condition or Disease	Intervention/Treatment	Phase
Physical Inactivity	Other: Physical Exercise Intervention	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 105 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Effects of Physical Exercise Timing On Strength and Cardiometabolic Health
• Anticipated Study Start Date: Nov 1, 2023
• Anticipated Primary Completion Date: May 31, 2026
• Anticipated Study Completion Date: May 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Single life-style coaching session
Experimental: Exercise Time 1 Physical exercise intervention taking place at one time of the day	Other: Physical Exercise Intervention; Two strength training session per week and one endurance training session per week
Experimental: Exercise Time 2 Physical exercise intervention taking place at another time of day	Other: Physical Exercise Intervention; Two strength training session per week and one endurance training session per week

Outcome Measures

Primary Outcome Measures

1. Maximum strength [Pre-Intervention (i.e. 1 to 28 days before the first training session of the exercise intervention) and Post-Intervention (i.e. 1 to 28 days after the last training session of the exercise intervention)]

   Mean value of the maximum isometric leg strength assessed at four different times of the day with an isokinetic dynamometer.

Secondary Outcome Measures

1. Glucose control [Pre-Intervention (i.e. 1 to 28 days before the first training session of the exercise intervention) and Post-Intervention (i.e. 1 to 28 days after the last training session of the exercise intervention)]

   3-h postprandial area under the curve for glucose after an oral glucose tolerance test

2. Body composition [Pre-Intervention (i.e. 1 to 28 days before the first training session of the exercise intervention) and Post-Intervention (i.e. 1 to 28 days after the last training session of the exercise intervention)]

   total body fat mass assessed with DXA

3. Cardiorespiratory fitness [Pre-Intervention (i.e. 1 to 28 days before the first training session of the exercise intervention) and Post-Intervention (i.e. 1 to 28 days after the last training session of the exercise intervention)]

   VO2max assessed with cardiopulmonary exercise test

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• BMI 18.5 - 30 kg/m2

Exclusion Criteria:

• Structured resistance training within the last six months

• Ongoing shift work

• Irregular bedtime (> 2 hours variation in habitual bed time)

• Smoking

• Travels across more than two time zones within the last four weeks

• Inability to follow the study procedures (e.g. due to language barriers, psychological disorders, dementia, etc.)

• Known pregnancy or lactating women

• Participation in any other clinical trial within the last four weeks

• Medical condition that is a contra indicator for resistance training, endurance training, or exercising until maximum exhaustion including insufficiently controlled blood pressure (systolic > 170 mmHg, diastolic > 100 mmHg), ongoing cancer treatment, unstable angina pectoris, uncontrolled bradyarrhythmia or tachyarrhythmia, severe uncorrected valvular heart disease, clinically relevant acute infection, any form of musculoskeletal injury, orthopedic problems or decompensated cardiovascular disease

• Insulin dependent diabetes

• Participants using metformin

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Basel	Basel		Switzerland	4052

Sponsors and Collaborators

• University of Basel

Investigators

• Principal Investigator: Raphael Knaier, PhD, University of Basel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Raphael Knaier, Researcher Group leader: Circadian Exercise, University of Basel
• ClinicalTrials.gov Identifier: NCT06063135
• Other Study ID Numbers: EPOCH
• First Posted: Oct 2, 2023
• Last Update Posted: Oct 2, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Oct 2, 2023