Overweight and ObesityNCT05092061
Resistance Training in Adults With Obesity
A study testing Moderate-repetition resistance training and High-repetition resistance training in people with Overweight and Obesity, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Moderate-repetition resistance training and High-repetition resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteNorway
- Study dates
- 14 Oct 2021to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Obesity (BMI ≥ 30) or
- Central obesity (defined according to the International Diabetes Federation).
Who cannot join
- Unstable angina
- recent cardiac infarction (last 4 weeks)
- uncompensated heart failure
- severe valvular illness
- pulmonary disease
- uncontrolled hypertension
Show all 11Show fewer
- kidney failure
- orthopaedic/neurological limitations
- cardiomyopathy
- planned operations during the research period
- participation in a parallel study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute and Chronic Effects of Two Different Types of Resistance Training on Cardiometabolic Health in Adults With Obesity
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.
- Conditions
- Overweight and Obesity
- Being tested
- Moderate-repetition resistance training, High-repetition resistance training
- Keywords
- Exercise therapy, Muscular strength, Resistance training, Fitness testing, Healthy lifestyle
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate-repetition resistance trainingOther
Will undertake resistance training with moderate loads, and moderate repetitions 3 times per week for 7 weeks.
High-repetition resistance trainingOther
Will undertake resistance training with low loads, and high repetitions 3 times per week for 7 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: High-repetition resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated haemoglobin (HbA1c)
Measured: 7 weeks
Secondary outcomes (16)
Fasting glucose
Measured: 7 weeks
Blood lipid concentration
Measured: 7 weeks
C-reactive protein
Measured: 7 weeks
Systolic blood pressure
Measured: 7 weeks
Diastolic blood pressure
Measured: 7 weeks
Body fat
Measured by bioelectrical impedance (InBody 770)
Measured: 7 weeks
Fat-free mass
Measured by bioelectrical impedance (InBody 770)
Measured: 7 weeks
Body mass
Measured by bioelectrical impedance (InBody 770)
Measured: 7 weeks
Visceral fat area
Measured by bioelectrical impedance (InBody 770)
Measured: 7 weeks
Waist circumference
Measured: 7 weeks
VO2max (maximal aerobic capacity)
Measured: 7 weeks
Rate of force development
Measured by Kistler force plate
Measured: 7 weeks
Muscular strength (1RM)
Leg press and bench press
Measured: 7 weeks
Muscular endurance
Maximum number of repetitions using 50% of 1-RM
Measured: 7 weeks
Physical activity
Assessed at three timepoints throughout the intervention using SenseWear armband activity monitors and/or Personal Activity IntelligenceTM (using heart rate monitors and smart phone application).
Measured: Baseline (before intervention), 4 and 7 weeks.
Health-Related Quality of Life
Using the Short-Form 36 survey and Satisfaction with Physical Function and Appearance Survey
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start14 Oct 2021
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will consist of both a crossover study model (acute phase) and parallel model (chronic phase).
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Øystein Risa, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05092061
- Sponsor's protocol ID
- 246888
- Status last verified
- May 2022
- First submitted
- 20 Sep 2021
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute and Chronic Effects of Two Different Types of Resistance Training on Cardiometabolic Health in Adults With Obesity
- ClinicalTrials.gov ID
- NCT05092061
- Acronym / sponsor ID
- 246888
- Conditions
- Overweight and Obesity
- Keywords
- Exercise therapy, Muscular strength, Resistance training, Fitness testing, Healthy lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 25 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will consist of both a crossover study model (acute phase) and parallel model (chronic phase).
| Arm | Type | Receives |
|---|---|---|
| Moderate-repetition resistance training | Experimental | Other: Moderate-repetition resistance trainingThe 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. |
| High-repetition resistance training | Experimental | Other: High-repetition resistance trainingThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Obesity (BMI ≥ 30) or
- Central obesity (defined according to the International Diabetes Federation).
Key exclusion criteria (11 listed)
- Unstable angina
- recent cardiac infarction (last 4 weeks)
- uncompensated heart failure
- severe valvular illness
- pulmonary disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate-repetition resistance trainingWill undertake resistance training with moderate loads, and moderate repetitions 3 times per week for 7 weeks. | Other | Moderate-repetition resistance training |
| High-repetition resistance trainingWill undertake resistance training with low loads, and high repetitions 3 times per week for 7 weeks. | Other | High-repetition resistance training |
Primary outcome
Glycated haemoglobin (HbA1c)
Time frame: 7 weeks
16 secondary outcomes
Fasting glucose
Time frame: 7 weeks
Blood lipid concentration
Time frame: 7 weeks
C-reactive protein
Time frame: 7 weeks
Systolic blood pressure
Time frame: 7 weeks
Diastolic blood pressure
Time frame: 7 weeks
Body fat
Time frame: 7 weeks
Fat-free mass
Time frame: 7 weeks
Body mass
Time frame: 7 weeks
Visceral fat area
Time frame: 7 weeks
Waist circumference
Time frame: 7 weeks
VO2max (maximal aerobic capacity)
Time frame: 7 weeks
Rate of force development
Time frame: 7 weeks
Muscular strength (1RM)
Time frame: 7 weeks
Muscular endurance
Time frame: 7 weeks
Physical activity
Time frame: Baseline (before intervention), 4 and 7 weeks.
Health-Related Quality of Life
Time frame: 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Øystein Risa study director
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate-repetition resistance training and High-repetition resistance training in people with Overweight and Obesity, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycated haemoglobin (HbA1c) (time frame: 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2022.