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Completed

NCT Number: NCT02998021

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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15206, United States

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Strength

    Time frame: Baseline and 12 weeks

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

  2. Change in Upper Extremity Pain

    Time frame: 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.

  3. Change in General Health Measures

    Time frame: 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.

  4. Changes in Functional Shoulder Pain

    Time frame: 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 outcomes

  1. Change in Peak Speed

    Time frame: Baseline and 12 weeks

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

  2. Change in Acceleration

    Time frame: Baseline and 12 weeks

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

  3. Change in Peak Force

    Time frame: Baseline and 12 weeks

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

  4. Change in Mechanical Effective Force

    Time frame: Baseline and 12 weeks

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

  5. Wheelchair Transfer Ability

    Time frame: Baseline and 12 weeks

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

  6. Power Output

    Time frame: Baseline and 12 weeks

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

Sponsors and collaborators

Lead sponsor

Alicia Koontz

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 20, 2016
Registry last updated
Dec 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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