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Flexibility and Strength Training in Asthma

FASTA: Flexibility and Strength Training in Asthma

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02370004
Acronym
FASTA
Enrollment
11
Registered
2015-02-24
Start date
2014-07-31
Completion date
2015-04-30
Last updated
2020-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma, RFST, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive, Lung Diseases

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.

Interventions

PROCEDUREResistive 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.

Sponsors

Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Forced Expiratory Volume at One Second - FEV1 % PredictedChange from baseline to end of study - 5 weeksForced expiratory volume - an assessment of pulmonary function

Secondary

MeasureTime frameDescription
Asthma Control Test (ACT)Change from baseline to end of study - 5 weeksAsthma 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- CircumferenceChange from baseline to end of study - 5 weeksRange 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 MotionChange from baseline to end of study- 5 weeksRange of motion measurements will help to assess the effectiveness of resistive flexibility and strength training. Range of motion was measured using degrees

Countries

United States

Participant flow

Participants by arm

ArmCount
Resistive Flexibility and Strength Training
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.
11
Total11

Baseline characteristics

CharacteristicResistive Flexibility and Strength Training
Age, Continuous22.8 years
Sex: Female, Male
Female
10 Participants
Sex: Female, Male
Male
1 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 11
serious
Total, serious adverse events
0 / 11

Outcome results

Primary

Forced Expiratory Volume at One Second - FEV1 % Predicted

Forced expiratory volume - an assessment of pulmonary function

Time frame: Change from baseline to end of study - 5 weeks

ArmMeasureGroupValue (MEAN)
Resistive Flexibility and Strength TrainingForced Expiratory Volume at One Second - FEV1 % PredictedPre Intervention91.4 % predicted
Resistive Flexibility and Strength TrainingForced Expiratory Volume at One Second - FEV1 % PredictedPost Intervention93.4 % predicted
Comparison: Paired T-tests were used to evaluate changes in spirometry resultsp-value: 0.1t-test, 2 sided
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.

Time frame: Change from baseline to end of study - 5 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Resistive Flexibility and Strength TrainingAsthma Control Test (ACT)Pre Intervention19.2 units on a scaleStandard Deviation 3.3
Resistive Flexibility and Strength TrainingAsthma Control Test (ACT)Post Intervention21.2 units on a scaleStandard Deviation 1.5
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

Time frame: Change from baseline to end of study - 5 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Resistive Flexibility and Strength TrainingRange of Motion Measurement- CircumferenceChest Circumference at Armpits, inhalation93.1 cmStandard Deviation 8.3
Resistive Flexibility and Strength TrainingRange of Motion Measurement- CircumferenceChest Circumference at Armpits, exhalation88.9 cmStandard Deviation 8.4
Resistive Flexibility and Strength TrainingRange of Motion Measurement- CircumferenceChest Circumference at Xiphoid, inhalation78.7 cmStandard Deviation 7.2
Resistive Flexibility and Strength TrainingRange of Motion Measurement- CircumferenceChest Circumference at Xiphoid, exhalation75.3 cmStandard Deviation 9.2
Range of Motion- Post Intervention- CircumferenceRange of Motion Measurement- CircumferenceChest Circumference at Xiphoid, exhalation77.6 cmStandard Deviation 9.7
Range of Motion- Post Intervention- CircumferenceRange of Motion Measurement- CircumferenceChest Circumference at Armpits, inhalation95.4 cmStandard Deviation 8.8
Range of Motion- Post Intervention- CircumferenceRange of Motion Measurement- CircumferenceChest Circumference at Xiphoid, inhalation82.4 cmStandard Deviation 8.7
Range of Motion- Post Intervention- CircumferenceRange of Motion Measurement- CircumferenceChest Circumference at Armpits, exhalation90.4 cmStandard Deviation 9.3
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

Time frame: Change from baseline to end of study- 5 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Resistive Flexibility and Strength TrainingRange of Motion Measurements- Degree of MotionFMS Shoulder Mobility Right9.6 DegreesStandard Deviation 9.4
Resistive Flexibility and Strength TrainingRange of Motion Measurements- Degree of MotionPosterior Arm Extension Right34.9 DegreesStandard Deviation 8.8
Resistive Flexibility and Strength TrainingRange of Motion Measurements- Degree of MotionFMS Shoulder Mobility Left8.5 DegreesStandard Deviation 7
Resistive Flexibility and Strength TrainingRange of Motion Measurements- Degree of MotionPosterior Arm Extension Left37.6 DegreesStandard Deviation 7.5
Resistive Flexibility and Strength TrainingRange of Motion Measurements- Degree of MotionArm Raise Right154.1 DegreesStandard Deviation 21.1
Resistive Flexibility and Strength TrainingRange of Motion Measurements- Degree of MotionArm Raise Left151.0 DegreesStandard Deviation 22.7
Range of Motion- Post Intervention- CircumferenceRange of Motion Measurements- Degree of MotionArm Raise Right165.6 DegreesStandard Deviation 20.9
Range of Motion- Post Intervention- CircumferenceRange of Motion Measurements- Degree of MotionFMS Shoulder Mobility Left8.5 DegreesStandard Deviation 8.8
Range of Motion- Post Intervention- CircumferenceRange of Motion Measurements- Degree of MotionFMS Shoulder Mobility Right8.1 DegreesStandard Deviation 7.8
Range of Motion- Post Intervention- CircumferenceRange of Motion Measurements- Degree of MotionPosterior Arm Extension Left38.7 DegreesStandard Deviation 9.7
Range of Motion- Post Intervention- CircumferenceRange of Motion Measurements- Degree of MotionPosterior Arm Extension Right39.7 DegreesStandard Deviation 10
Range of Motion- Post Intervention- CircumferenceRange of Motion Measurements- Degree of MotionArm Raise Left165.4 DegreesStandard Deviation 18.3

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026