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Effect of Vibration Exercise on Upper Limb Strength, Function, and Pain

Primary Purpose

Spinal Cord Injuries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vibrating Dumbbell
Standard Dumbbell
Sponsored by
Alicia Koontz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • have a neurological impairment secondary to spinal cord injury (SCI) or disease at T2 or lower
  • greater than 6 months post injury
  • use a manual wheelchair as primary means of mobility (at least 30 hrs. per week)
  • 18 to 65 years of age
  • provide signed medical release by primary care physician to engage in a high-intensity resistance training exercise program
  • live within 60 minutes driving time (1 hour) from the research center
  • able to perform a transfer independently to and from a wheelchair
  • have normal range of motion in the upper limbs.

Exclusion Criteria:

  • history of fractures or dislocations in the shoulder, elbow and wrist from which the subject has not fully recovered or joint replacement of any of the joints in the upper extremities
  • upper limb pain that interferes with the ability to propel or transfer
  • recent hospitalization for any reason (within the past three months)
  • pregnant women
  • history of coronary artery disease, coronary bypass surgery or other cardio-respiratory events

Sites / Locations

  • University of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Resistance Training - Vibrating Dumbbell

Resistance Training - Standard Dumbbell

Arm Description

Study participants who are randomized into the vibration exercise group will complete an in-home exercise program using a vibrating dumbbell.

Study participants who are randomized into the control exercise group will complete an in-home exercise program using standard dumbbells.

Outcomes

Primary Outcome Measures

Change in Strength
Measurement of peak torque (Nm/kg) for Shoulder Adduction. Measurement was done using the Biodex System.
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.
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.
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.

Secondary Outcome Measures

Change in Peak Speed
Change in peak speed (m/s) measured on a 3 degree incline. Measurement will be done using the SmartWheel.
Change in Acceleration
Change in acceleration (seconds) during the 250 foot level propulsion task.
Change in Peak Force
Change in peak force (N) during the 250 foot level propulsion task. Measurement was done using the SmartWheel.
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.
Wheelchair Transfer Ability
Measurement of relative transfer range. Measured as the change in relative uphill (maximum) transfer height (inches).
Power Output
Measurement of peak power output (watts/kg) using the Load Arm Ergometer.

Full Information

First Posted
December 13, 2016
Last Updated
December 19, 2019
Sponsor
Alicia Koontz
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1. Study Identification

Unique Protocol Identification Number
NCT02998021
Brief Title
Effect of Vibration Exercise on Upper Limb Strength, Function, and Pain
Official Title
Effect of Vibration Exercise on Upper Limb Strength, Function, and Pain
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
March 15, 2017 (Actual)
Primary Completion Date
November 20, 2018 (Actual)
Study Completion Date
November 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Alicia Koontz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resistance Training - Vibrating Dumbbell
Arm Type
Experimental
Arm Description
Study participants who are randomized into the vibration exercise group will complete an in-home exercise program using a vibrating dumbbell.
Arm Title
Resistance Training - Standard Dumbbell
Arm Type
Active Comparator
Arm Description
Study participants who are randomized into the control exercise group will complete an in-home exercise program using standard dumbbells.
Intervention Type
Device
Intervention Name(s)
Vibrating Dumbbell
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Standard Dumbbell
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Strength
Description
Measurement of peak torque (Nm/kg) for Shoulder Adduction. Measurement was done using the Biodex System.
Time Frame
Baseline and 12 weeks
Title
Change in Upper Extremity Pain
Description
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.
Time Frame
Baseline and 12 weeks
Title
Change in General Health Measures
Description
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.
Time Frame
Baseline and 12 weeks
Title
Changes in Functional Shoulder Pain
Description
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.
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Change in Peak Speed
Description
Change in peak speed (m/s) measured on a 3 degree incline. Measurement will be done using the SmartWheel.
Time Frame
Baseline and 12 weeks
Title
Change in Acceleration
Description
Change in acceleration (seconds) during the 250 foot level propulsion task.
Time Frame
Baseline and 12 weeks
Title
Change in Peak Force
Description
Change in peak force (N) during the 250 foot level propulsion task. Measurement was done using the SmartWheel.
Time Frame
Baseline and 12 weeks
Title
Change in Mechanical Effective Force
Description
Change in mechanical effective force during 250 foot level propulsion task (no unit) Measurement will be done using the SmartWheel.
Time Frame
Baseline and 12 weeks
Title
Wheelchair Transfer Ability
Description
Measurement of relative transfer range. Measured as the change in relative uphill (maximum) transfer height (inches).
Time Frame
Baseline and 12 weeks
Title
Power Output
Description
Measurement of peak power output (watts/kg) using the Load Arm Ergometer.
Time Frame
Baseline and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: have a neurological impairment secondary to spinal cord injury (SCI) or disease at T2 or lower greater than 6 months post injury use a manual wheelchair as primary means of mobility (at least 30 hrs. per week) 18 to 65 years of age provide signed medical release by primary care physician to engage in a high-intensity resistance training exercise program live within 60 minutes driving time (1 hour) from the research center able to perform a transfer independently to and from a wheelchair have normal range of motion in the upper limbs. Exclusion Criteria: history of fractures or dislocations in the shoulder, elbow and wrist from which the subject has not fully recovered or joint replacement of any of the joints in the upper extremities upper limb pain that interferes with the ability to propel or transfer recent hospitalization for any reason (within the past three months) pregnant women history of coronary artery disease, coronary bypass surgery or other cardio-respiratory events
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alicia Koontz, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States

12. IPD Sharing Statement

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Effect of Vibration Exercise on Upper Limb Strength, Function, and Pain

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