Comparison of the Immediate Effects of a Hypopressive Abdominal Exercise Program Versus a Proprioceptive Neuromuscular Facilitation Stretching Program on Hamstring Flexibility in Adults With Short Hamstring Syndrome

December 30, 2024 updated by: Pablo Hernandez-Lucas, University of Vigo
A Randomised Controlled Trial was conducted to assess increases in hamstring flexibility using two different methods, one group of participants who were stretched with PNF techniques and the other group who performed Hypopressive Abdominal Techniques (HAT). Flexibility scores of both groups were obtained and compared using pre and post measurements of a single intervention.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Pontevedra, Spain, 36005
        • Facultade de fisioterapia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants with less than 75° in the straight leg raise test.

Exclusion Criteria:

  • History of hamstring injury within the last year.
  • Pharmacological treatment or history of neurological, orthopaedic, growth or autoimmune disorders.
  • Training to improve flexibility in the week prior to the intervention.
  • Hypertension.
  • Pregnant women.
  • Inability to perform hypopressive abdominal techniques.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Hypopressive abdominal techniques
All subjects were instructed by a registered physiotherapist on how to correctly perform the hypopressive abdominal techniques (HAT) in two familiarisation sessions of 45 minutes each before any action was taken. After the two sessions, all subjects who did not learn the exercise correctly were dropped from the study. The HAT training consisted of asking subjects in a standing position to perform a spinal elongation with neutral pelvis and scapular muscle activation for three normal respiratory cycles with slow and deep exhalation, and on the last breath, an expiratory apnoea with rib expansion and elevation was requested. In this session, following the guidelines described in the familiarisation sessions, two series of four dynamic HATs in standing position were performed: dynamic HATs in right tilt, dynamic HATs in left tilt, dynamic HATs in right rotation and dynamic HATs in left rotation.
Behavioral: Hypopressive abdominal techniques
Both training protocols were carried out in a single intervention for each of the participants assigned to either the HAT or the PNF stretching group. The intervention began with the measurement of hip flexion using the EPR test, and ended with a post-intervention measurement of hip flexion to observe the effects of the treatment. All measurements, as well as the interventions for each of the patients in the two groups, were carried out by the same registered physiotherapist. In order to standardise an order of examination of the lower limbs in the EPR test, the right lower limb was assessed first, followed by the left lower limb. Likewise, the same order was standardised for stretching in the PNF group.
Active Comparator: Stretching of proprioceptive neuromuscular facilitation
The therapist straddled that leg, and raised the other leg by placing the heel on the shoulder. The therapist then flexed the participant's hip, maintaining knee extension, to the point of discomfort indicated by the patient or the therapist's perceived end of range. In this position the leg was held straight for 10 seconds and immediately afterwards the participant was asked to perform a maximum isometric contraction for 5 seconds using the therapist's shoulder as counter resistance, thus keeping the leg straight at the same point. As soon as the contraction stops, the therapist flexes the hip again until a new range limit is reached, repeating the same protocol again. The total duration is 60 seconds, consisting of 4 passive stretches of 10 seconds each and 4 isometric contractions against resistance of 5 seconds each.
Behavioral: Stretching of proprioceptive neuromuscular facilitation
Stretching of proprioceptive neuromuscular facilitation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Straight leg raise test.
Time Frame: Baseline changes at the end of the intervention (approximately one hour).
The subject in supine decubitus. The patient's unscanned leg was kept stretched out on the stretcher by means of thigh straps. A digital inclinometer was placed on the other leg over the tibia before starting to lift the leg, in order to be able to quantify the degrees obtained during the test. The therapist will place one hand on the patient's heel holding the calcaneus to prevent rotation and the other on the patella to prevent the knee from flexing during the test. The examiner shall then perform a slow, progressive flexion of the hip with the knee extended, starting from 0° at rest and considering 90° when the lower limb is completely perpendicular to the examination couch. The angular value is taken as the maximum degree of flexion tolerated by the individual, the moment at which the pelvis begins to tilt in retroversion or when the examiner perceives a feeling of firm resistance.
Baseline changes at the end of the intervention (approximately one hour).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Toe-Floor Distance test
Time Frame: Baseline changes at the end of the intervention (approximately one hour).
The Toe-Floor Distance test was also used as a tool to measure the flexibility of the hamstring muscles. The subject stood on a platform without shoes and with feet hip-width apart. The subject was asked to lean forward, flexing the trunk as far as possible, keeping the knees, arms and fingers fully extended. The vertical distance between the tip of the middle finger and the platform was measured with a flexible tape measure and expressed in centimetres. The vertical distance between the platform and the tip of the middle finger was positive when the subject did not reach the platform and negative when the subject could reach further.
Baseline changes at the end of the intervention (approximately one hour).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Vigo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 26, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 8, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 2, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 10, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Andres TFM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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