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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resistive Flexibility and Strength Training | Experimental | Each subject will undergo Resistive Flexibility and Strength Training (RFST) with a trained practitioner. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resistive Flexibility and Strength Training | Procedure | 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 | 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elliot Israel, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Forced Expiratory Volume at One Second - FEV1 % Predicted | Forced expiratory volume - an assessment of pulmonary function | Posted | Mean | 95% Confidence Interval | % predicted | Change from baseline to end of study - 5 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elliot Israel | Brigham and Women's Hospital | 6177328201 | eisrael@partners.org |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| ID | Term |
|---|---|
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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|
| 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 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to end of study - 5 weeks |
|
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| 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 | Posted | Mean | Standard Deviation | cm | 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 | Posted | Mean | Standard Deviation | Degrees | Change from baseline to end of study- 5 weeks |
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| 0 |
| 11 |
| 0 |
| 11 |
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| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| Chest Circumference at Xiphoid, inhalation |
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| Chest Circumference at Xiphoid, exhalation |
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| Posterior Arm Extension Left |
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| Posterior Arm Extension Right |
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| Arm Raise Left |
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| Arm Raise Right |
|