Flexibility and Strength Training in Asthma (FASTA)

May 28, 2020 updated by: Elliot Israel, MD, Brigham and Women's Hospital

FASTA: Flexibility and Strength Training in Asthma

The aim of the study is proof of concept and to establish the feasibility of performing a study of resistive flexibility and strength training (RFST) in patients with asthma, with the future goal of designing a larger randomized trial to test the hypothesis that RFST leads to greater improvement in asthma symptoms, pulmonary function tests, range of motion and connective tissue mobility compared with a control conventional physical therapy 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.

Detailed Description

The treatment of symptomatic asthma currently focuses on the use of medications - inhaled or systemic - that have the principal goals of relieving airway pathology, namely airway narrowing, inflammation, mucus metaplasia and hyper-reactivity. There are no therapies directed at the chest wall or its connective tissue structural units, including connective tissue matrix, bone health and chest wall musculature. Resistive flexibility and strength training (RFST) is a new physical therapy technique that has successfully addressed abnormalities in the upper and lower extremities and back. In this application, we propose to use internal funding for a pilot project to explore the potential holistic benefits of RFST directed to the chest wall in symptomatic asthmatics as well as the potential mechanical basis of its therapeutic benefits if observed.

In RFST, the practitioner extends or flexes a joint, while the patient actively resists the motion applied by the practitioner. In other words, the patient performs an eccentric contraction of extensor muscles if the joint is flexed, or of flexor muscles if the joint is extended. The technique is based on the following theoretical principles:

  • Opposing muscle pairs (i.e. ipsilateral flexor/extensor) can become dysfunctional when connective tissue within one of the muscles (either the flexor or the extensor) becomes chronically shortened-thought to be due to long-standing exaggerated centrally driven tonic muscle activity either following an injury or due to posture habit. When this happens, connective tissue within the opposing muscle will become chronically lengthened due to shortening of the paired muscle.
  • The connective tissue can become inelastic and restrictive resulting in the muscles being held in a chronically short or lengthened position. These positions can change.
  • In the trunk, imbalances can occur between flexor/extensor groups (e.g. psoas/multifidus) and also between right/left muscle pairs, creating postural asymmetries. For example, shortening of the psoas muscle on one side will lead to lengthening of the psoas on the contralateral side.
  • Shortening of limb girdle muscles (e.g. pectoralis, gluteus) can create complex imbalance patterns both across local flexor/extensor pairs, across sides, and diagonally across the trunk (e.g. shortening of pectoralis major on one side causing lengthening of extensor muscles in contralateral hip).
  • The end result of these imbalances is that the shortened muscles restrict the range of movement, and the lengthened muscles cannot function optimally in a lengthened position.

It is thought that resistance stretching 1) allows the shortened muscles to lengthen and the lengthened muscles to shorten by remodeling intramuscular and perimuscular connective tissue, 2) allows lengthened muscles to contract at a more favorable length and 3) allows for an increase in flexion, extension, and flexibility through joint ranges of motion.

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.
11

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

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female patients, age ≥ 18 yrs
  • Physician-diagnosed asthma
  • Currently taking asthma medications
  • Asthma Control Questionnaire (ACQ) score >1.25

Exclusion Criteria:

  • Smoking history of ≥10 pack years
  • Pregnancy or lactation or subjects planning to get pregnant during the course of the trial
  • Major medical problems prohibiting study participation, i.e. presence of chronic or active lung disease other than asthma or history of unstable significant medical illness other than asthma or concurrent medical problems that would place the participant at increased risk as determined by the study physician

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: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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: Resistive Flexibility and Strength Training
Each subject will undergo Resistive Flexibility and Strength Training (RFST) with a trained practitioner.
Procedure: Resistive Flexibility and Strength Training

RFST is a physical therapy technique where a certified practitioner extends or flexes a joint with the subject actively resists the motion applied by the practitioner.

During the RFST treatment a subject will lie on a massage table while the practitioner holds the subject's arm or leg and flexes or extends the limb, instructing the patient to resist the flexion or extension produced by the practitioner. The process is repeated a number of times for each muscle while varying joint positions.

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
Forced Expiratory Volume at One Second - FEV1 % Predicted
Time Frame: Change from baseline to end of study - 5 weeks
Forced expiratory volume - an assessment of pulmonary function
Change from baseline to end of study - 5 weeks

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
Asthma Control Test (ACT)
Time Frame: Change from baseline to end of study - 5 weeks

Asthma Control Test is a questionnaire that assesses asthma control by asking about asthma symptoms during the last month.

The minimum score is 5 and the maximum is 25. Any score <20 represents asthma that is not well controlled, the lower the number the worse the control.
Change from baseline to end of study - 5 weeks
Range of Motion Measurement- Circumference
Time Frame: Change from baseline to end of study - 5 weeks
Range of motion measurements will help to assess the effectiveness of resistive flexibility and strength training. Circumference was measured using centimeters
Change from baseline to end of study - 5 weeks
Range of Motion Measurements- Degree of Motion
Time Frame: Change from baseline to end of study- 5 weeks
Range of motion measurements will help to assess the effectiveness of resistive flexibility and strength training. Range of motion was measured using degrees
Change from baseline to end of study- 5 weeks

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.
Brigham and Women's Hospital

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

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.
July 1, 2014

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.
April 1, 2015

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.
April 1, 2015

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).
September 2, 2014

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.
February 18, 2015

First Posted (Estimate)

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.
February 24, 2015

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.
June 4, 2020

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.
May 28, 2020

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.
May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • 2014p000994

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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