Flexibility and Strength Training in Asthma (FASTA)

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: Completed
• Conditions: Asthma
• Intervention / Treatment: Procedure: Resistive Flexibility and Strength Training

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: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from baseline to end of study - 5 weeks
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	Change from baseline to end of study - 5 weeks
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	Change from baseline to end of study- 5 weeks

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: September 2, 2014
• First Submitted That Met QC Criteria: February 18, 2015
• First Posted (Estimate): February 24, 2015

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: May 28, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; RFST
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 2014p000994