NCT05092061

Brief Summary

The purpose of this project is two-fold: (1) to assess if two different resistance training protocols elicit different responses in the acute phase and (2) to assess if the same two different protocols will elicit different long-term responses on muscular strength, body composition and cardiometabolic health. The project will include 30 adults with obesity (defined as BMI ≥ 30 or abdominal obesity according to the International Diabetes Federation). In the acute phase blood lactate, heart rate, enjoyment and perceived exertion will be assessed after the two resistance training protocols. In addition, the mean 24-h blood glucose concentration after exercise will be compared between the two protocols. For the long-term effects blood markers of cardiometabolic health, blood pressure, body composition, objectively measured physical activity and physical fitness will be assessed before and after the intervention. Also, perceived health-related quality of life will be assessed before and after the intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2021

Completed
24 days until next milestone

Study Start

First participant enrolled

October 14, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 25, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

May 26, 2022

Status Verified

May 1, 2022

Enrollment Period

5 months

First QC Date

September 20, 2021

Last Update Submit

May 25, 2022

Conditions

Keywords

Exercise therapyMuscular strengthResistance trainingFitness testingHealthy lifestyle

Outcome Measures

Primary Outcomes (1)

  • Glycated haemoglobin (HbA1c)

    7 weeks

Secondary Outcomes (16)

  • Fasting glucose

    7 weeks

  • Blood lipid concentration

    7 weeks

  • C-reactive protein

    7 weeks

  • Systolic blood pressure

    7 weeks

  • Diastolic blood pressure

    7 weeks

  • +11 more secondary outcomes

Study Arms (2)

Moderate-repetition resistance training

EXPERIMENTAL

The participants will undergo a full-body resistance training protocol with moderate repetitions (6-12), moderate load (70-85% of 1RM), and moderate rest between sets (60-90s). Training will be undertaken three times per week.

Other: Moderate-repetition resistance training

High-repetition resistance training

EXPERIMENTAL

The participants will undergo a full-body resistance training protocol with high repetitions (15+), low load (\<60% of 1RM), and short rest between sets (30s). Training will be undertaken three times per week.

Other: High-repetition resistance training

Interventions

Will undertake resistance training with moderate loads, and moderate repetitions 3 times per week for 7 weeks.

Moderate-repetition resistance training

Will undertake resistance training with low loads, and high repetitions 3 times per week for 7 weeks.

High-repetition resistance training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Obesity (BMI ≥ 30) or
  • Central obesity (defined according to the International Diabetes Federation).

You may not qualify if:

  • Unstable angina
  • recent cardiac infarction (last 4 weeks)
  • uncompensated heart failure
  • severe valvular illness
  • pulmonary disease
  • uncontrolled hypertension
  • kidney failure
  • orthopaedic/neurological limitations
  • cardiomyopathy
  • planned operations during the research period
  • participation in a parallel study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Circulation and Medical Imaging

Trondheim, 7491, Norway

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Øystein Risa

    Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The study will consist of both a crossover study model (acute phase) and parallel model (chronic phase).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2021

First Posted

October 25, 2021

Study Start

October 14, 2021

Primary Completion

February 28, 2022

Study Completion

February 28, 2022

Last Updated

May 26, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations