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Trial record 65 of 10364 for:    strength

Flexibility and Strength Training in Asthma (FASTA)

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ClinicalTrials.gov Identifier: NCT02370004
Recruitment Status : Completed
First Posted : February 24, 2015
Last Update Posted : April 4, 2016
Sponsor:
Information provided by (Responsible Party):
Elliot Israel, MD, Brigham and Women's Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Asthma Procedure: Resistive Flexibility and Strength Training Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: FASTA: Flexibility and Strength Training in Asthma
Study Start Date : July 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
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.





Primary Outcome Measures :
  1. Forced expiratory volume at one second - FEV1 [ Time Frame: Change from baseline to end of study - 5 weeks ]
    Forced expiratory volume - an assessment of pulmonary function


Secondary Outcome Measures :
  1. 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

  2. Range of Motion Measurements [ 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02370004


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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Principal Investigator: Elliot Israel, MD Brigham and Women's Hospital

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Responsible Party: Elliot Israel, MD, Director, Asthma Research Center, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02370004     History of Changes
Other Study ID Numbers: 2014p000994
First Posted: February 24, 2015    Key Record Dates
Last Update Posted: April 4, 2016
Last Verified: March 2016
Keywords provided by Elliot Israel, MD, Brigham and Women's Hospital:
Asthma
RFST
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases