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

NCT02998021 | Completed Results FDA Device

• 1 other identifier: PRO16010169
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (6)

• Change in Peak Speed

  Baseline and 12 weeks

• Change in Acceleration

  Baseline and 12 weeks

• Change in Peak Force

  Baseline and 12 weeks

• Change in Mechanical Effective Force

  Baseline and 12 weeks

• Wheelchair Transfer Ability

  Baseline and 12 weeks

Study Arms (2)

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.

Device: 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.

Device: Standard Dumbbell

Interventions

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.

Resistance Training - Vibrating Dumbbell

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.

Resistance Training - Standard Dumbbell

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Alicia Koontz: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15206, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Results Point of Contact

• Title: Alicia Koontz, PhD
• Organization: University of Pittsburgh

akoontz@pitt.edu

4128223700

Study Officials

• Alicia Koontz, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 13, 2016
• First Posted: December 20, 2016
• Study Start: March 15, 2017
• Primary Completion: November 20, 2018
• Study Completion: November 20, 2018
• Last Updated: December 23, 2019
• Results First Posted: December 23, 2019

Record last verified: 2019-12

Locations

US (1)