FASTA: Flexibility and Strength Training in Asthma

• Sponsor: Brigham and Women's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02370004
• Collaborator: (none)
• Enrollment: 11
• Location: 1
• Arm: 1
• Duration (Months): 9
• Patients Per Site Per Month: 1.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Procedure: Resistive Flexibility and Strength Training	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 11 participants
• Allocation: N/A
• 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: Jul 1, 2014
• Actual Primary Completion Date: Apr 1, 2015
• Actual Study Completion Date: Apr 1, 2015

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Forced Expiratory Volume at One Second - FEV1 % Predicted [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) [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.

2. Range of Motion Measurement- Circumference [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

3. Range of Motion Measurements- Degree of Motion [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Brigham and Women's Hospital

Investigators

• Principal Investigator: Elliot Israel, MD, Brigham and Women's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Elliot Israel, MD, Director, Asthma Research Center, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT02370004
• Other Study ID Numbers: 2014p000994
• First Posted: Feb 24, 2015
• Last Update Posted: Jun 4, 2020
• Last Verified: May 1, 2020

• Keywords provided by Elliot Israel, MD, Director, Asthma Research Center, Brigham and Women's Hospital: Asthma; RFST; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases
• Additional relevant MeSH terms: Asthma

Study Results

Participant Flow

Arm/Group Title	Resistive Flexibility and Strength Training
Arm/Group Description	Each subject will undergo Resistive Flexibility and Strength Training (RFST) with a trained practitioner. 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.
Period Title: Overall Study
STARTED	11
COMPLETED	10
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Resistive Flexibility and Strength Training
Arm/Group Description	Each subject will undergo Resistive Flexibility and Strength Training (RFST) with a trained practitioner. 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.
Overall Participants	11
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	22.8
Sex: Female, Male (Count of Participants)
Female	10 90.9%
Male	1 9.1%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Resistive Flexibility and Strength Training
Arm/Group Description	Each subject will undergo Resistive Flexibility and Strength Training (RFST) with a trained practitioner. 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.
Measure Participants	10
Pre Intervention	91.4
Post Intervention	93.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Resistive Flexibility and Strength Training
	Comments	Paired T-tests were used to evaluate changes in spirometry results
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	.10
	Comments
	Method	t-test, 2 sided
	Comments

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Asthma Control Test
Arm/Group Description	Asthma Control Test which is a measure of asthma control and symptoms over the last four weeks
Measure Participants	10
Pre Intervention	19.2 (3.3)
Post Intervention	21.2 (1.5)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Range of Motion- Pre Intervention- Circumference	Range of Motion- Post Intervention- Circumference
Arm/Group Description	Range of Motion and mobility- pre intervention	Range of Motion - Post intervention
Measure Participants	10	10
Chest Circumference at Armpits, inhalation	93.1 (8.3)	95.4 (8.8)
Chest Circumference at Armpits, exhalation	88.9 (8.4)	90.4 (9.3)
Chest Circumference at Xiphoid, inhalation	78.7 (7.2)	82.4 (8.7)
Chest Circumference at Xiphoid, exhalation	75.3 (9.2)	77.6 (9.7)

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Range of Motion- Pre Intervention- Degree	Range of Motion- Post Intervention- Degree
Arm/Group Description	Range of Motion and mobility- pre intervention	Range of Motion - Post intervention
Measure Participants	10	10
FMS Shoulder Mobility Left	8.5 (7.0)	8.5 (8.8)
FMS Shoulder Mobility Right	9.6 (9.4)	8.1 (7.8)
Posterior Arm Extension Left	37.6 (7.5)	38.7 (9.7)
Posterior Arm Extension Right	34.9 (8.8)	39.7 (10.0)
Arm Raise Left	151.0 (22.7)	165.4 (18.3)
Arm Raise Right	154.1 (21.1)	165.6 (20.9)

Adverse Events

Arm/Group Title	Resistive Flexibility and Strength Training
Arm/Group Description	Each subject will undergo Resistive Flexibility and Strength Training (RFST) with a trained practitioner. 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.
All Cause Mortality
	Resistive Flexibility and Strength Training
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Resistive Flexibility and Strength Training
	Affected / at Risk (%)	# Events
Total	0/11 (0%)
Other (Not Including Serious) Adverse Events
	Resistive Flexibility and Strength Training
	Affected / at Risk (%)	# Events
Total	0/11 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.