Healthy VolunteersNCT03830112
Effect of Two Pilates-based Mat Exercise Programs on the Isometric Strength of Core Muscles in Healthy Men
A study testing Pilates exercise with Theraband and Pilates exercise in people with Healthy Volunteers, run by Universidad de Antioquia at 1 site in Colombia.
Trial summary
Based on the current evidence, it is known that Pilates is an exercise technique that has been used mainly by women in sport, fitness and rehabilitation. Most research has been developed with women. Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Pilates exercise with Theraband and Pilates exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteColombia
- Study dates
- 14 Aug 2018to 30 Mar 2019
- 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 to 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers.
- Perform ≤150 minutes of aerobic exercise per week.
Who cannot join
- Perform any Pilates exercise previously.
- Smoker.
- History of asthma.
- History of diabetes.
- History of hypertension.
- History of cardiovascular disease.
Show all 11Show fewer
- History of coronary heart disease.
- Arrhythmias.
- Under medical treatment with anticoagulants, beta-blockers, calcium antagonists, bronchodilators, and/or steroids.
- Psychological, neuromotor and/or osteo-muscular conditions that may affect participation in an exercise program.
- People with metal prosthesis.
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Centro de Formación en Actividad Física y Cultura
Bogotá, Cundinamarca
About this study
Official title: Effects of a Pilates-based Mat Exercise Program Compared to a Pilates-based Mat Exercise With Resistance Band on the Isometric Strength of Core Muscles, Lean Mass, and Body Fat in Men 18 to 25 Years
Based on the current evidence, it is known that Pilates is an exercise technique that has been used mainly by women in sport, fitness and rehabilitation. Most research has been developed with women. The participation of men in the research studies is reduced and methodology rigor is low, therefore, there is insufficient evidence on the effects of this type of training in men, in addition, there are no studies that have proven the effects of a Pilates-based mat exercise with resistance band on strength of core muscles.
The main objective of this research is to identify the effects of a Pilates-based mat exercise program versus a Pilates-based exercise mat program with resistance band on the isometric strength of the core muscles in men 18 to 25 years.
Read the detailed description
Fifty-eight men will be randomly assigned to one of two Pilates exercise programs. Pilates-based mat exercise and Pilates-based mat exercise with Theraband® (blue color). Interventions will be performed three times a week for eight-weeks on alternate days. Half will perform Pilates-based mat exercise and the remaining 29 will perform Pilates-based mat exercise with Theraband®. Both groups complete eleven exercises from week one to four and twelve exercises from week five to eight.
- Conditions
- Healthy Volunteers
- Being tested
- Pilates exercise with Theraband, Pilates exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates exercise with TherabandBehavioural
The experimental group will perform all the exercises with Theraband® in the same manner than active comparator group.
Pilates exerciseBehavioural
The active comparator group will perform all the exercises without Theraband®
| Study group | Role | What they receive |
|---|---|---|
| Pilates exercise with Theraband | Experimental | 24 exercise sessions, 3x weekly (on alternate days).
11 Pilates-based exercises with Theraband® (blue color) from week one to four. (hundred,roll up, one leg circle,rolling like a ball,single leg stretch, double leg stretch,single straight leg stretch, double straight leg lower lift, criss-cross, spine stretch, corkscrew).
12 Pilates-based exercises with Theraband® (blue color) from week five to eight.
(saw, rest position, shoulder bridge, side, kick, front ad back, up and down, teaser, swimming, leg pull front, mermaid, seal, push up).
Every participant will perform three isometric repetitions of 30 seconds per exercise, with 10 seconds recovery between repetitions and 30 seconds rest between each exercise. Receives: Behavioral: Pilates exercise with Theraband |
| Pilates exercise | Active comparator | 24 exercise sessions, 3x weekly (on alternate days).
11 Pilates-based mat exercises from week one to four. (hundred,roll up, one leg circle,rolling like a ball,single leg stretch, double leg stretch,single straight leg stretch, double straight leg lower lift, criss-cross, spine stretch, corkscrew).
12 Pilates-based mat exercises from week five to eight. (saw, rest position, shoulder bridge, side, kick, front ad back, up and down, teaser, swimming, leg pull front, mermaid, seal, push up).
Every participant will perform three isometric repetitions of 30 seconds per exercise, with 10 seconds recovery between repetitions and 30 seconds rest between each exercise. Receives: Behavioral: Pilates exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in isometric strength of the core muscles
Isometric strength of the core muscles will be obtained using TorsoCheck (Ergo-Fit®, Germany).
Measured: Baseline and after 8 weeks
Secondary outcomes (2)
Change in lean mass
Lean mass will be obtained using Bioelectrical impedance (SECA mBCA515, Gmbh\&Co.,Hamburg,Germany)
Measured: Baseline and after 8 weeks
Change in body fat
Body fat will be obtained using Bioelectrical impedance (SECA mBCA515,Gmbh\&Co.,Hamburg,Germany).
Measured: Baseline and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start14 Aug 2018
- Primary completion20 Feb 2019
- Study completion30 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Antioquia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victor Hugo Arboleda Serna, Universidad de Antioquia
- Investigators
- Víctor H Arboleda Serna, PhD, Principal investigator, Universidad de Antioquia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03830112
- Sponsor's protocol ID
- Mat Pilates
- Status last verified
- Jun 2019
- First submitted
- 1 Feb 2019
- Last updated
- 10 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Pilates-based Mat Exercise Program Compared to a Pilates-based Mat Exercise With Resistance Band on the Isometric Strength of Core Muscles, Lean Mass, and Body Fat in Men 18 to 25 Years
- ClinicalTrials.gov ID
- NCT03830112
- Acronym / sponsor ID
- Mat Pilates
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Study start
- 14 Aug 2018 (actual)
- Primary completion
- 20 Feb 2019 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 5 Feb 2019 (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.
Based on the current evidence, it is known that Pilates is an exercise technique that has been used mainly by women in sport, fitness and rehabilitation. Most research has been developed with women. The participation of men in the research studies is reduced and methodology rigor is low, therefore, there is insufficient evidence on the effects of this type of training in men, in addition, there are no studies that have proven the effects of a Pilates-based mat exercise with resistance band on strength of core muscles.
The main objective of this research is to identify the effects of a Pilates-based mat exercise program versus a Pilates-based exercise mat program with resistance band on the isometric strength of the core muscles in men 18 to 25 years.
Detailed description
Fifty-eight men will be randomly assigned to one of two Pilates exercise programs. Pilates-based mat exercise and Pilates-based mat exercise with Theraband® (blue color). Interventions will be performed three times a week for eight-weeks on alternate days. Half will perform Pilates-based mat exercise and the remaining 29 will perform Pilates-based mat exercise with Theraband®. Both groups complete eleven exercises from week one to four and twelve exercises from week five to eight.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilates exercise with Theraband | Experimental | Behavioral: Pilates exercise with Theraband24 exercise sessions, 3x weekly (on alternate days). 11 Pilates-based exercises with Theraband® (blue color) from week one to four. (hundred,roll up, one leg circle,rolling like a ball,single leg stretch, double leg stretch,single straight leg stretch, double straight leg lower lift, criss-cross, spine stretch, corkscrew). 12 Pilates-based exercises with Theraband® (blue color) from week five to eight. (saw, rest position, shoulder bridge, side, kick, front ad back, up and down, teaser, swimming, leg pull front, mermaid, seal, push up). Every participant will perform three isometric repetitions of 30 seconds per exercise, with 10 seconds recovery between repetitions and 30 seconds rest between each exercise. |
| Pilates exercise | Active comparator | Behavioral: Pilates exercise24 exercise sessions, 3x weekly (on alternate days). 11 Pilates-based mat exercises from week one to four. (hundred,roll up, one leg circle,rolling like a ball,single leg stretch, double leg stretch,single straight leg stretch, double straight leg lower lift, criss-cross, spine stretch, corkscrew). 12 Pilates-based mat exercises from week five to eight. (saw, rest position, shoulder bridge, side, kick, front ad back, up and down, teaser, swimming, leg pull front, mermaid, seal, push up). Every participant will perform three isometric repetitions of 30 seconds per exercise, with 10 seconds recovery between repetitions and 30 seconds rest between each exercise. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy volunteers.
- Perform ≤150 minutes of aerobic exercise per week.
Key exclusion criteria (11 listed)
- Perform any Pilates exercise previously.
- Smoker.
- History of asthma.
- History of diabetes.
- History of hypertension.
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 |
|---|---|---|
| Pilates exercise with TherabandThe experimental group will perform all the exercises with Theraband® in the same manner than active comparator group. | Behavioural | Pilates exercise with Theraband |
| Pilates exerciseThe active comparator group will perform all the exercises without Theraband® | Behavioural | Pilates exercise |
Primary outcome
Change in isometric strength of the core muscles
Time frame: Baseline and after 8 weeks
Isometric strength of the core muscles will be obtained using TorsoCheck (Ergo-Fit®, Germany).
2 secondary outcomes
Change in lean mass
Time frame: Baseline and after 8 weeks
Change in body fat
Time frame: Baseline and after 8 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 10 Jun 2019.
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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.
Víctor H Arboleda Serna, PhD principal investigator
Universidad de Antioquia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates exercise with Theraband and Pilates exercise in people with Healthy Volunteers, run by Universidad de Antioquia at 1 site in Colombia.
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 10 Jun 2019. 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 Colombia. 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?
Change in isometric strength of the core muscles (time frame: Baseline and after 8 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 10 Jun 2019.