Sensitivity Training GroupsNCT03410329
Effect of Different Frequencies Weekly Training in Overweight/Obese Women
A study testing Resistance training in people with Sensitivity Training Groups, run by Francesco Campa.
Trial summary
The aim of this study was to evaluate the effects of a resistance training programme of one or three times a week on body composition, cardiometabolic risk factors and handgrip strength in overweight and obese women Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sensitivity Training Groups
- What is being tested?
- Resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2016to 27 Jun 2017
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- overweight or obese
Who cannot join
- -
About this study
Official title: Comparison of the Effect of Different Frequencies Weekly Training on Body Composition, Cardiometabolic Risk Factors and Handgrip Strength in Overweight and Obese Women
The aim of this study was to evaluate the effects of a resistance training programme of one or three times a week on body composition, cardiometabolic risk factors and handgrip strength in overweight and obese women
Read the detailed description
This study aimed to determine the effects of supervised structured 6 months resistance training and a restricted caloric diet on body composition, cardiometabolic risk factors and handgrip strength in overweight and obese women. 45 women were randomly assigned to one of two groups: a group with a high-weekly frequency of three times a week (HIGH) and a group that performed only one weekly session (LOW).HbA1c, percentage of fat mass and handgrip strength were taken before and after the intervention period.
- Conditions
- Sensitivity Training Groups
- Being tested
- Resistance training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance trainingOther
Physical activity
| Study group | Role | What they receive |
|---|---|---|
| High weekly training frequency | Experimental | three sessions a week of resistance training Receives: Other: Resistance training |
| Low weekly training frequency | Experimental | one workouts per week Receives: Other: Resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat mass
anthropometric measurements
Measured: 24 weeks
Secondary outcomes (1)
Handgrip strength
mechanical dynamometer
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2018
- Study start1 Dec 2016
- Primary completion1 Jun 2017
- Study completion27 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensitivity Training GroupsStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Francesco Campa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Francesco Campa, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03410329
- Sponsor's protocol ID
- 12022016
- Status last verified
- Jan 2018
- First submitted
- 12 Jan 2018
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Different Frequencies Weekly Training on Body Composition, Cardiometabolic Risk Factors and Handgrip Strength in Overweight and Obese Women
- ClinicalTrials.gov ID
- NCT03410329
- Acronym / sponsor ID
- 12022016
- Conditions
- Sensitivity Training Groups
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Francesco CampaUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 27 Jun 2017 (actual)
- First posted
- 25 Jan 2018 (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 aim of this study was to evaluate the effects of a resistance training programme of one or three times a week on body composition, cardiometabolic risk factors and handgrip strength in overweight and obese women
Detailed description
This study aimed to determine the effects of supervised structured 6 months resistance training and a restricted caloric diet on body composition, cardiometabolic risk factors and handgrip strength in overweight and obese women. 45 women were randomly assigned to one of two groups: a group with a high-weekly frequency of three times a week (HIGH) and a group that performed only one weekly session (LOW).HbA1c, percentage of fat mass and handgrip strength were taken before and after the intervention period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High weekly training frequency | Experimental | Other: Resistance trainingthree sessions a week of resistance training |
| Low weekly training frequency | Experimental | Other: Resistance trainingone workouts per week |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- overweight or obese
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Resistance trainingPhysical activity | Other | High weekly training frequency, Low weekly training frequency |
Primary outcome
Fat mass
Time frame: 24 weeks
anthropometric measurements
1 secondary outcome
Handgrip strength
Time frame: 24 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 25 Jan 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance training in people with Sensitivity Training Groups, run by Francesco Campa.
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 1 inclusion and 1 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 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Fat mass (time frame: 24 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 25 Jan 2018.