Precision Exercise Therapeutics (PET-pilot)

NCT ID: NCT05718089

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-07-30

Brief Summary

The aim of this randomized cross-over study is to collect information for the design of a precision exercise therapy cohort that will predict what modality of physical activity a physically inactive individual with overweight should perform to increase insulin sensitivity given their unique biology, environment, and context.

Detailed Description

This pilot study is needed prior to launching precision therapeutics programs, with the purpose to decrease the risk of research waste, increase the reliability of the experimental tests and estimate adequate sample size.

25 participants will be recruited to undergo three sets of experiments. An experiment consists of one exercise bout followed by an assessment of whole-body insulin sensitivity (measured from a oral glucose tolerance test) 1 and 2 days following the completion of the exercise bout yielding 19 study days of 3 hours each across 7 weeks, including the baseline measurement. The exercise modalities include 1) continuous aerobic exercise, 2) high intensity exercise and 3) resistance exercise training. A set consists of test-retest of the same experiment.

The objectives of this pilot study are

1. to assess the longevity of the increased whole-body insulin sensitivity in the days following different exercise modalities

2. To estimate the intra-individual differences of different exercise modalities on whole-body insulin sensitivity the days following the last exercise bout

3. To assess the fidelity of the test- and exercise protocols

Conditions

Overweight; Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Continuous aerobic exercise

The participants will complete a 10-min warm up, followed by 40 min of continuous aerobic exercise at an individualized intensity at 64-76% of the maximal heart rate HRmax on a bicycle ergometer/walking.

Group Type: EXPERIMENTAL

Continuous aerobic exercise

Intervention Type: OTHER

The "Continuous aerobic exercise" session will be performed in total two times, as it will be repeated in sets on consecutive weeks (e.g. Two Tuesdays in a row) with a 1-week wash-out period. The " Continuous aerobic exercise" intervention is matched to the other arms on the time spend for each bout equating a total of 50 minutes of exercise per session.

An oral glucose tolerance test will be performed 24 hours and 48 hours after the exercise bout.

High intensity interval training

The training consists of 10 minutes of warm up followed by 25 minutes of high intensity interval training (5 bouts of 4 min at \>85% HRmax interspaced by 4 minutes of low intensity training) and finally a 4 min cool-down.

Group Type: EXPERIMENTAL

High intensity interval training

Intervention Type: OTHER

The "High intensity interval training" session will be performed in total two times, as it will be repeated in sets on consecutive weeks (e.g. Two Tuesdays in a row) with a 1-week wash-out period. The "High intensity interval training" intervention is matched to the other arms on the time spend for each bout equating a total of 50 minutes of exercise per session.

An oral glucose tolerance test will be performed 24 hours and 48 hours after the exercise bout.

Resistance training

The participants will complete moderate intensity whole-body resistance training. This will consist of 4 sets with 4 exercises (leg press, chest press, back row, leg extension in appropriate machines) with a brief warm-up prior to each exercise. Each set will be interspersed by 2-min breaks. Each set (including breaks) will thus equate to 2.5 min. Intensity will be set a 12-repetition max (RM, i.e., can repeated no more than 12 times) or 10 repetitions with 1-2 repetitions in reserve (i.e., 10 repetitions where failure would occur within 1-2 more repetitions).

Group Type: EXPERIMENTAL

Resistance training

Intervention Type: OTHER

The "Resistance training" session will be performed in total two times, as it will be repeated in sets on consecutive weeks (e.g. Two Tuesdays in a row) with a 1-week wash-out period. The "Resistance training" intervention is matched to the other arms on the time spend for each bout equating a total of 50 minutes of exercise per session.

An oral glucose tolerance test will be performed 24 hours and 48 hours after the exercise bout.

Interventions

Continuous aerobic exercise

The "Continuous aerobic exercise" session will be performed in total two times, as it will be repeated in sets on consecutive weeks (e.g. Two Tuesdays in a row) with a 1-week wash-out period. The " Continuous aerobic exercise" intervention is matched to the other arms on the time spend for each bout equating a total of 50 minutes of exercise per session.

An oral glucose tolerance test will be performed 24 hours and 48 hours after the exercise bout.

Intervention Type: OTHER

High intensity interval training

The "High intensity interval training" session will be performed in total two times, as it will be repeated in sets on consecutive weeks (e.g. Two Tuesdays in a row) with a 1-week wash-out period. The "High intensity interval training" intervention is matched to the other arms on the time spend for each bout equating a total of 50 minutes of exercise per session.

An oral glucose tolerance test will be performed 24 hours and 48 hours after the exercise bout.

Intervention Type: OTHER

Resistance training

The "Resistance training" session will be performed in total two times, as it will be repeated in sets on consecutive weeks (e.g. Two Tuesdays in a row) with a 1-week wash-out period. The "Resistance training" intervention is matched to the other arms on the time spend for each bout equating a total of 50 minutes of exercise per session.

An oral glucose tolerance test will be performed 24 hours and 48 hours after the exercise bout.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• BMI>25
• Age> 40 years
• Inactivity, defined as < 1,5 hours of structured physical activity pr. week at moderate intensity and cycling < 30 minutes/5 km pr. day at moderate intensity (moderate intensity = out of breath but able to speak)

Exclusion Criteria

• • HbA1c>53 mmol/mol

• Uncontrolled hypertension
• Uncontrolled hyperlipidemia,
• Known hyperthyroid disease
• Endocrine disorders causing obesity
• Known autoimmune disease
• Unstable cardiovascular disease
• Glucose lowering medications except for low dose metformin (=<1000 mg/day)
• Current treatment with anti-inflammatory medication, unless pain killers without prescription
• No participation in other research intervention studies
• Pregnancy/considering pregnancy within the study period
• Conditions countering exercise

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Cody Garett Durrer

PhD. Postdoc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mathias Ried-Larsen, Ph D

Role: PRINCIPAL_INVESTIGATOR

Center for Physical Activity Research, Rigshospitalet

Locations

Center for Aktiv Sundhed - Rigshospitalet, Denmark (CFAS)

Copenhagen, Østerbro, Denmark

Countries

Denmark

Other Identifiers

H-22040452

Identifier Type: -

Identifier Source: org_study_id