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The primary purpose of this study is to explore the benefits of vibration dumbbell resistance training over standard dumbbell resistance training for improving upper limb strength, function and pain among manual wheelchair users with paraplegia.
Objectives: The primary purpose of this study is to explore the benefits of vibration dumbbell resistance training over standard dumbbell resistance training for improving upper limb strength, function and pain among manual wheelchair users with paraplegia.
Experimental Design: Design: Randomized Control Trial
Methods: Twenty subjects with paraplegia will be recruited and randomized into two groups, a vibration dumbbell training (V-DT) group and a standard dumbbell training group (S-DT). Both groups will participate in a supervised 12-week (3 sessions per week) dumbbell (free-weight) strength training program consisting of nine exercises specifically designed to improve upper limb muscle function to support propulsion and transfer activities and protect the shoulders from developing pain. For each of the nine exercises the vibration group will hold a high-frequency (40 Hz) vibrating dumbbell in a static arm posture (isometric training) while the control group will move a non-vibrating dumbbell through the full range of motion for a given exercise (isotonic training). Both groups will follow a standardized protocol for assessing and progressing the amount of weight that is added to the dumbbell to achieve optimal training effects.
All participants will participate in laboratory testing for various outcome measures at baseline, 6 weeks and 12 weeks .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resistance Training - Vibrating Dumbbell | Experimental | Study participants who are randomized into the vibration exercise group will complete an in-home exercise program using a vibrating dumbbell. |
|
| Resistance Training - Standard Dumbbell | Active Comparator | Study participants who are randomized into the control exercise group will complete an in-home exercise program using standard dumbbells. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vibrating Dumbbell | Device | Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks. The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively, first by increasing the frequency of the vibration (max. 40 Hz) then by the addition of more weight, based on weekly assessments and consultation with the senior investigators. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Strength | Measurement of peak torque (Nm/kg) for Shoulder Adduction. Measurement was done using the Biodex System. | Baseline and 12 weeks |
| Change in Upper Extremity Pain | Score generated by the Numerical Rating Scale for shoulder pain. Participants self report upper extremity pain over the last 24 hours with scores on a 0 to 10 scale. Higher scores represent higher levels of pain. | Baseline and 12 weeks |
| Change in General Health Measures | Score generated by the Short Form 36 walk-wheel. Participants self report on health questions within 8 domains each of which are scored from 0 to 100. The scores from each of the subscales are then averaged together to obtain an overall total score. A score of 0 represents the worst possible health state and a score of 100 represents the best possible health state. | Baseline and 12 weeks |
| Changes in Functional Shoulder Pain | Score generated by the Wheelchair Users Shoulder Pain Index. Participants self report shoulder pain over the past week while performing activities of daily living. Scores range from 1 to 150 where higher scores represent higher levels of pain. | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Peak Speed | Change in peak speed (m/s) measured on a 3 degree incline. Measurement will be done using the SmartWheel. | Baseline and 12 weeks |
| Change in Acceleration | Change in acceleration (seconds) during the 250 foot level propulsion task. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alicia Koontz, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15206 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Resistance Training - Vibrating Dumbbell | Study participants who are randomized into the vibration exercise group will complete an in-home exercise program using a vibrating dumbbell. Vibrating Dumbbell: Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks. The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively, first by increasing the frequency of the vibration (max. 40 Hz) then by the addition of more weight, based on weekly assessments and consultation with the senior investigators. |
| FG001 | Resistance Training - Standard Dumbbell | Study participants who are randomized into the control exercise group will complete an in-home exercise program using standard dumbbells. Standard Dumbbell: Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks. The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively by the addition of more weight, based on weekly assessments and consultation with the senior investigators. To obtain as much data as possible on resistance training with vibration within study timeline, a modification was recently approved by the IRB to cease enrolling subjects into standard dumbbell training. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Resistance Training - Vibrating Dumbbell | Study participants who are randomized into the vibration exercise group will complete an in-home exercise program using a vibrating dumbbell. Vibrating Dumbbell: Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks. The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively, first by increasing the frequency of the vibration (max. 40 Hz) then by the addition of more weight, based on weekly assessments and consultation with the senior investigators. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change in Strength | Measurement of peak torque (Nm/kg) for Shoulder Adduction. Measurement was done using the Biodex System. | Subjects in the control group withdrew before the 12 week visit. There were technical problems with collected the strength data for one subject in the intervention group. | Posted | Mean | Standard Deviation | Nm/kg | Baseline and 12 weeks |
|
1 year, 9 months
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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 | Resistance Training - Vibrating Dumbbell | Study participants who are randomized into the vibration exercise group will complete an in-home exercise program using a vibrating dumbbell. Vibrating Dumbbell: Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks. The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively, first by increasing the frequency of the vibration (max. 40 Hz) then by the addition of more weight, based on weekly assessments and consultation with the senior investigators. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alicia Koontz, PhD | University of Pittsburgh | 4128223700 | akoontz@pitt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 24, 2019 | Nov 20, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| Standard Dumbbell | Device | Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks. The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively by the addition of more weight, based on weekly assessments and consultation with the senior investigators. To obtain as much data as possible on resistance training with vibration within study timeline, a modification was recently approved by the Institutional Review Board (IRB) to cease enrolling subjects into standard dumbbell training. |
|
| Baseline and 12 weeks |
| Change in Peak Force | Change in peak force (N) during the 250 foot level propulsion task. Measurement was done using the SmartWheel. | Baseline and 12 weeks |
| Change in Mechanical Effective Force | Change in mechanical effective force during 250 foot level propulsion task (no unit) Measurement will be done using the SmartWheel. | Baseline and 12 weeks |
| Wheelchair Transfer Ability | Measurement of relative transfer range. Measured as the change in relative uphill (maximum) transfer height (inches). | Baseline and 12 weeks |
| Power Output | Measurement of peak power output (watts/kg) using the Load Arm Ergometer. | Baseline and 12 weeks |
| BG001 | Resistance Training - Standard Dumbbell | Study participants who are randomized into the control exercise group will complete an in-home exercise program using standard dumbbells. Standard Dumbbell: Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks. The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively by the addition of more weight, based on weekly assessments and consultation with the senior investigators. To obtain as much data as possible on resistance training with vibration within study timeline, a modification was recently approved by the IRB to cease enrolling subjects into standard dumbbell training. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Resistance Training - Standard Dumbbell | Study participants who are randomized into the control exercise group will complete an in-home exercise program using standard dumbbells. Standard Dumbbell: Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks. The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively by the addition of more weight, based on weekly assessments and consultation with the senior investigators. To obtain as much data as possible on resistance training with vibration within study timeline, a modification was recently approved by the IRB to cease enrolling subjects into standard dumbbell training. |
|
|
| Primary | Change in Upper Extremity Pain | Score generated by the Numerical Rating Scale for shoulder pain. Participants self report upper extremity pain over the last 24 hours with scores on a 0 to 10 scale. Higher scores represent higher levels of pain. | Subjects in the control group withdrew before the 12 week visit | Posted | Median | Full Range | units on the scale | Baseline and 12 weeks |
|
|
|
| Primary | Change in General Health Measures | Score generated by the Short Form 36 walk-wheel. Participants self report on health questions within 8 domains each of which are scored from 0 to 100. The scores from each of the subscales are then averaged together to obtain an overall total score. A score of 0 represents the worst possible health state and a score of 100 represents the best possible health state. | Subjects in the control group withdrew before the 12 week visit | Posted | Mean | Standard Deviation | units on the scale | Baseline and 12 weeks |
|
|
|
| Primary | Changes in Functional Shoulder Pain | Score generated by the Wheelchair Users Shoulder Pain Index. Participants self report shoulder pain over the past week while performing activities of daily living. Scores range from 1 to 150 where higher scores represent higher levels of pain. | Subjects in the control group withdrew before the 12 week visit | Posted | Mean | Standard Deviation | units on the scale | Baseline and 12 weeks |
|
|
|
| Secondary | Change in Peak Speed | Change in peak speed (m/s) measured on a 3 degree incline. Measurement will be done using the SmartWheel. | Subjects in the control group withdrew before the 12 week visit. There were technical issues that prevented SmartWheel data collection for 3 subjects in the intervention group. | Posted | Mean | Standard Deviation | meters/second | Baseline and 12 weeks |
|
|
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| Secondary | Change in Acceleration | Change in acceleration (seconds) during the 250 foot level propulsion task. | Subjects in the control group withdrew before the 12 week visit | Posted | Mean | Standard Deviation | seconds | Baseline and 12 weeks |
|
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| Secondary | Change in Peak Force | Change in peak force (N) during the 250 foot level propulsion task. Measurement was done using the SmartWheel. | Subjects in the control group withdrew before the 12 week visit. There were technical issues preventing the SmartWheel data collection for 3 subjects in the intervention group | Posted | Mean | Standard Deviation | Newtons | Baseline and 12 weeks |
|
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|
| Secondary | Change in Mechanical Effective Force | Change in mechanical effective force during 250 foot level propulsion task (no unit) Measurement will be done using the SmartWheel. | Subjects in the control group withdrew before the 12 week visit. There were technical issues prevention SmartWheel data collection for 3 subjects in the intervention group. | Posted | Mean | Standard Deviation | unitless | Baseline and 12 weeks |
|
|
|
| Secondary | Wheelchair Transfer Ability | Measurement of relative transfer range. Measured as the change in relative uphill (maximum) transfer height (inches). | Subjects in the control group withdrew before the 12 week visit | Posted | Median | Full Range | inches | Baseline and 12 weeks |
|
|
|
| Secondary | Power Output | Measurement of peak power output (watts/kg) using the Load Arm Ergometer. | Subjects in the control group withdrew before the 12 week visit | Posted | Mean | Standard Deviation | Watts/kg | Baseline and 12 weeks |
|
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| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Resistance Training - Standard Dumbbell | Study participants who are randomized into the control exercise group will complete an in-home exercise program using standard dumbbells. Standard Dumbbell: Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks. The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively by the addition of more weight, based on weekly assessments and consultation with the senior investigators. To obtain as much data as possible on resistance training with vibration within study timeline, a modification was recently approved by the IRB to cease enrolling subjects into standard dumbbell training. | 0 | 2 | 0 | 2 | 0 | 2 |
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| D014947 | Wounds and Injuries |