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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02998021

Enrollment

Registered

2016-12-20

Start date

2017-03-15

Completion date

2018-11-20

Last updated

2019-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injuries

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 .

Interventions

DEVICEVibrating 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.

DEVICEStandard 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 Institutional Review Board (IRB) to cease enrolling subjects into standard dumbbell training.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Change in Upper Extremity Pain	Baseline and 12 weeks	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 Strength	Baseline and 12 weeks	Measurement of peak torque (Nm/kg) for Shoulder Adduction. Measurement was done using the Biodex System.
Change in General Health Measures	Baseline and 12 weeks	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	Baseline and 12 weeks	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

Measure	Time frame	Description
Wheelchair Transfer Ability	Baseline and 12 weeks	Measurement of relative transfer range. Measured as the change in relative uphill (maximum) transfer height (inches).
Change in Peak Speed	Baseline and 12 weeks	Change in peak speed (m/s) measured on a 3 degree incline. Measurement will be done using the SmartWheel.
Power Output	Baseline and 12 weeks	Measurement of peak power output (watts/kg) using the Load Arm Ergometer.
Change in Acceleration	Baseline and 12 weeks	Change in acceleration (seconds) during the 250 foot level propulsion task.
Change in Peak Force	Baseline and 12 weeks	Change in peak force (N) during the 250 foot level propulsion task. Measurement was done using the SmartWheel.
Change in Mechanical Effective Force	Baseline and 12 weeks	Change in mechanical effective force during 250 foot level propulsion task (no unit) Measurement will be done using the SmartWheel.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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.	8
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.	2
Total	10

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	unsafe home	0	1
Overall Study	Withdrawal by Subject	3	1

Baseline characteristics

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

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 8	0 / 2
other Total, other adverse events	0 / 8	0 / 2
serious Total, serious adverse events	0 / 8	0 / 2

Outcome results

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.