Flexibility and Strength Training in Asthma (FASTA)
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resistive Flexibility and Strength Training
Sponsored by

About this trial
This is an interventional supportive care trial for Asthma focused on measuring Asthma, RFST, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive, Lung Diseases
Eligibility 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
Sites / Locations
- Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Resistive Flexibility and Strength Training
Arm Description
Each subject will undergo Resistive Flexibility and Strength Training (RFST) with a trained practitioner.
Outcomes
Primary Outcome Measures
Forced Expiratory Volume at One Second - FEV1 % Predicted
Forced expiratory volume - an assessment of pulmonary function
Secondary Outcome Measures
Asthma Control Test (ACT)
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.
Range of Motion Measurement- Circumference
Range of motion measurements will help to assess the effectiveness of resistive flexibility and strength training. Circumference was measured using centimeters
Range of Motion Measurements- Degree of Motion
Range of motion measurements will help to assess the effectiveness of resistive flexibility and strength training. Range of motion was measured using degrees
Full Information
NCT ID
NCT02370004
First Posted
September 2, 2014
Last Updated
May 28, 2020
Sponsor
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02370004
Brief Title
Flexibility and Strength Training in Asthma
Acronym
FASTA
Official Title
FASTA: Flexibility and Strength Training in Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, RFST, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive, Lung Diseases
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Resistive Flexibility and Strength Training
Arm Type
Experimental
Arm Description
Each subject will undergo Resistive Flexibility and Strength Training (RFST) with a trained practitioner.
Intervention Type
Procedure
Intervention Name(s)
Resistive Flexibility and Strength Training
Intervention Description
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 Measure Information:
Title
Forced Expiratory Volume at One Second - FEV1 % Predicted
Description
Forced expiratory volume - an assessment of pulmonary function
Time Frame
Change from baseline to end of study - 5 weeks
Secondary Outcome Measure Information:
Title
Asthma Control Test (ACT)
Description
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.
Time Frame
Change from baseline to end of study - 5 weeks
Title
Range of Motion Measurement- Circumference
Description
Range of motion measurements will help to assess the effectiveness of resistive flexibility and strength training. Circumference was measured using centimeters
Time Frame
Change from baseline to end of study - 5 weeks
Title
Range of Motion Measurements- Degree of Motion
Description
Range of motion measurements will help to assess the effectiveness of resistive flexibility and strength training. Range of motion was measured using degrees
Time Frame
Change from baseline to end of study- 5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elliot Israel, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
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Flexibility and Strength Training in Asthma
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