Flexibility and Strength Training in Asthma

Asthma Clinical Trial

— FASTA  

Official title:

FASTA: Flexibility and Strength Training in Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02370004
• Other study ID #: 2014p000994
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: April 2015

Study information

• Verified date: May 2020
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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