Precision Exercise Therapeutics (PET-pilot)

Rigshospitalet

Status: Completed

Conditions: Healthy; Overweight

Treatments: Other: Continuous aerobic exercise; Other: Resistance training; Other: High intensity interval training

Study type: Interventional

Funder types: Other

Identifiers

NCT05718089

H-22040452

Details and patient eligibility

About

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.

Full 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

Enrollment: 24 patients

Sex: All

Ages: 40 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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24 participants in 3 patient groups

Continuous aerobic exercise

Experimental group

Description:

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.

Treatment:

Other: Continuous aerobic exercise

High intensity interval training

Experimental group

Description:

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.

Treatment:

Other: High intensity interval training

Resistance training

Experimental group

Description:

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).

Treatment:

Other: Resistance training