Trial Outcomes & Findings for Effect of Vibration Exercise on Upper Limb Strength, Function, and Pain (NCT NCT02998021)

NCT ID: NCT02998021

Last Updated: 2019-12-23

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: Baseline and 12 weeks
• Results posted on: 2019-12-23

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	8	2
Overall Study COMPLETED	5	0
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Measure	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.	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.
Overall Study Withdrawal by Subject	3	1
Overall Study unsafe home	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Resistance Training - Vibrating Dumbbell n=8 Participants 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.	Resistance Training - Standard Dumbbell n=2 Participants 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.	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	2 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	47.6 years STANDARD_DEVIATION 9.9 • n=5 Participants	41.4 years STANDARD_DEVIATION 3.5 • n=7 Participants	46.4 years STANDARD_DEVIATION 9.2 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	1 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	2 participants n=7 Participants	10 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Population: 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.

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

Outcome measures

Measure	Resistance Training - Vibrating Dumbbell n=4 Participants 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.	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.
Change in Strength	-4.0 Nm/kg Standard Deviation 12.4	—

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Population: Subjects in the control group withdrew before the 12 week visit

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.

Outcome measures

Measure	Resistance Training - Vibrating Dumbbell n=5 Participants 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.	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.
Change in Upper Extremity Pain	0 units on the scale Interval -1.0 to 0.0	—

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Population: Subjects in the control group withdrew before the 12 week visit

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.

Outcome measures

Measure	Resistance Training - Vibrating Dumbbell n=5 Participants 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.	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.
Change in General Health Measures	5.0 units on the scale Standard Deviation 15.3	—

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Population: Subjects in the control group withdrew before the 12 week visit

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.

Outcome measures

Measure	Resistance Training - Vibrating Dumbbell n=5 Participants 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.	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.
Changes in Functional Shoulder Pain	1.4 units on the scale Standard Deviation 10.2	—

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: 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.

Change in peak speed (m/s) measured on a 3 degree incline. Measurement will be done using the SmartWheel.

Outcome measures

Measure	Resistance Training - Vibrating Dumbbell n=2 Participants 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.	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.
Change in Peak Speed	-0.08 meters/second Standard Deviation 0.07	—

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: Subjects in the control group withdrew before the 12 week visit

Change in acceleration (seconds) during the 250 foot level propulsion task.

Outcome measures

Measure	Resistance Training - Vibrating Dumbbell n=5 Participants 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.	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.
Change in Acceleration	1.8 seconds Standard Deviation 2.4	—

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: 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

Change in peak force (N) during the 250 foot level propulsion task. Measurement was done using the SmartWheel.

Outcome measures

Measure	Resistance Training - Vibrating Dumbbell n=2 Participants 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.	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.
Change in Peak Force	10.1 Newtons Standard Deviation 14.4	—

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: 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.

Change in mechanical effective force during 250 foot level propulsion task (no unit) Measurement will be done using the SmartWheel.

Outcome measures

Measure	Resistance Training - Vibrating Dumbbell n=2 Participants 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.	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.
Change in Mechanical Effective Force	0.06 unitless Standard Deviation 0.17	—

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: Subjects in the control group withdrew before the 12 week visit

Measurement of relative transfer range. Measured as the change in relative uphill (maximum) transfer height (inches).

Outcome measures

Measure	Resistance Training - Vibrating Dumbbell n=5 Participants 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.	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.
Wheelchair Transfer Ability	1 inches Interval -2.0 to 3.0	—

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: Subjects in the control group withdrew before the 12 week visit

Measurement of peak power output (watts/kg) using the Load Arm Ergometer.

Outcome measures

Measure	Resistance Training - Vibrating Dumbbell n=5 Participants 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.	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.
Power Output	0.5 Watts/kg Standard Deviation 1.5	—

Adverse Events

Resistance Training - Vibrating Dumbbell

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Resistance Training - Standard Dumbbell

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

Alicia Koontz, PhD

University of Pittsburgh

Phone: 4128223700

Email: akoontz@pitt.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place