Trial Outcomes & Findings for Flexibility and Strength Training in Asthma (NCT NCT02370004)
NCT ID: NCT02370004
Last Updated: 2020-06-04
Results Overview
Forced expiratory volume - an assessment of pulmonary function
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
Change from baseline to end of study - 5 weeks
Results posted on
2020-06-04
Participant Flow
Participant milestones
| Measure |
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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|---|---|
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Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Flexibility and Strength Training in Asthma
Baseline characteristics by cohort
| Measure |
Resistive Flexibility and Strength Training
n=11 Participants
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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|---|---|
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Age, Continuous
|
22.8 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
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Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to end of study - 5 weeksForced expiratory volume - an assessment of pulmonary function
Outcome measures
| Measure |
Resistive Flexibility and Strength Training
n=10 Participants
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.
|
Range of Motion- Post Intervention- Circumference
Range of Motion - Post intervention
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|---|---|---|
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Forced Expiratory Volume at One Second - FEV1 % Predicted
Pre Intervention
|
91.4 % predicted
Interval 81.6 to 97.3
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—
|
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Forced Expiratory Volume at One Second - FEV1 % Predicted
Post Intervention
|
93.4 % predicted
Interval 83.6 to 99.3
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—
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Resistive Flexibility and Strength Training
n=10 Participants
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.
|
Range of Motion- Post Intervention- Circumference
Range of Motion - Post intervention
|
|---|---|---|
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Asthma Control Test (ACT)
Pre Intervention
|
19.2 units on a scale
Standard Deviation 3.3
|
—
|
|
Asthma Control Test (ACT)
Post Intervention
|
21.2 units on a scale
Standard Deviation 1.5
|
—
|
SECONDARY outcome
Timeframe: Change 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
Outcome measures
| Measure |
Resistive Flexibility and Strength Training
n=10 Participants
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.
|
Range of Motion- Post Intervention- Circumference
n=10 Participants
Range of Motion - Post intervention
|
|---|---|---|
|
Range of Motion Measurement- Circumference
Chest Circumference at Armpits, inhalation
|
93.1 cm
Standard Deviation 8.3
|
95.4 cm
Standard Deviation 8.8
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Range of Motion Measurement- Circumference
Chest Circumference at Armpits, exhalation
|
88.9 cm
Standard Deviation 8.4
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90.4 cm
Standard Deviation 9.3
|
|
Range of Motion Measurement- Circumference
Chest Circumference at Xiphoid, inhalation
|
78.7 cm
Standard Deviation 7.2
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82.4 cm
Standard Deviation 8.7
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|
Range of Motion Measurement- Circumference
Chest Circumference at Xiphoid, exhalation
|
75.3 cm
Standard Deviation 9.2
|
77.6 cm
Standard Deviation 9.7
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SECONDARY outcome
Timeframe: Change 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
Outcome measures
| Measure |
Resistive Flexibility and Strength Training
n=10 Participants
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.
|
Range of Motion- Post Intervention- Circumference
n=10 Participants
Range of Motion - Post intervention
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|---|---|---|
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Range of Motion Measurements- Degree of Motion
FMS Shoulder Mobility Left
|
8.5 Degrees
Standard Deviation 7.0
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8.5 Degrees
Standard Deviation 8.8
|
|
Range of Motion Measurements- Degree of Motion
FMS Shoulder Mobility Right
|
9.6 Degrees
Standard Deviation 9.4
|
8.1 Degrees
Standard Deviation 7.8
|
|
Range of Motion Measurements- Degree of Motion
Posterior Arm Extension Left
|
37.6 Degrees
Standard Deviation 7.5
|
38.7 Degrees
Standard Deviation 9.7
|
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Range of Motion Measurements- Degree of Motion
Posterior Arm Extension Right
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34.9 Degrees
Standard Deviation 8.8
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39.7 Degrees
Standard Deviation 10.0
|
|
Range of Motion Measurements- Degree of Motion
Arm Raise Left
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151.0 Degrees
Standard Deviation 22.7
|
165.4 Degrees
Standard Deviation 18.3
|
|
Range of Motion Measurements- Degree of Motion
Arm Raise Right
|
154.1 Degrees
Standard Deviation 21.1
|
165.6 Degrees
Standard Deviation 20.9
|
Adverse Events
Resistive Flexibility and Strength Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place