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

NCT ID: NCT02998021

Last Updated: 2019-12-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-15
• Study Completion Date: 2018-11-20

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 .

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Vibrating Dumbbell

Intervention Type: 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 - Standard Dumbbell

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

Group Type: ACTIVE_COMPARATOR

Standard Dumbbell

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alicia Koontz

OTHER

Sponsor Role: lead

Responsible Party

Alicia Koontz

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Alicia Koontz, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PRO16010169

Identifier Type: -

Identifier Source: org_study_id