NCT03830112

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P50-P75 for not_applicable healthy-volunteers

Timeline
Completed

Started Aug 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 14, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2019

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2019

Completed
Last Updated

June 10, 2019

Status Verified

June 1, 2019

Enrollment Period

6 months

First QC Date

February 1, 2019

Last Update Submit

June 6, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in isometric strength of the core muscles

    Isometric strength of the core muscles will be obtained using TorsoCheck (Ergo-Fit®, Germany).

    Baseline and after 8 weeks

Secondary Outcomes (2)

  • Change in lean mass

    Baseline and after 8 weeks

  • Change in body fat

    Baseline and after 8 weeks

Study Arms (2)

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.

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.

Behavioral: Pilates exercise

Interventions

The experimental group will perform all the exercises with Theraband® in the same manner than active comparator group.

Pilates exercise with Theraband

The active comparator group will perform all the exercises without Theraband®

Pilates exercise

Eligibility Criteria

Age18 Years - 25 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers.
  • Perform ≤150 minutes of aerobic exercise per week.

You may not qualify if:

  • Perform any Pilates exercise previously.
  • Smoker.
  • History of asthma.
  • History of diabetes.
  • History of hypertension.
  • History of cardiovascular disease.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro de Formación en Actividad Física y Cultura

Bogotá, Cundinamarca, Colombia

Location

MeSH Terms

Interventions

Exercise Movement Techniques

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Study Officials

  • Víctor H Arboleda Serna, PhD

    Universidad de Antioquia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 1, 2019

First Posted

February 5, 2019

Study Start

August 14, 2018

Primary Completion

February 20, 2019

Study Completion

March 30, 2019

Last Updated

June 10, 2019

Record last verified: 2019-06

Locations