NCT02533063

Brief Summary

This proposed prospective study will evaluate whether a novel exercise approach, seated vibration therapy, can improve function in the target population of older adults. Therefore, the primary aim of this pilot is to examine the effect of vibration therapy on muscle function (balance, muscle power and strength) and muscle mass.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 26, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2017

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

April 2, 2019

Completed
Last Updated

April 2, 2019

Status Verified

March 1, 2019

Enrollment Period

1.3 years

First QC Date

August 19, 2015

Results QC Date

October 31, 2018

Last Update Submit

March 8, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Weight Corrected Jump Power Based on Participant's Jump on the Jump Force Plate

    The primary aim of this pilot is to examine the effect of vibration therapy on muscle function. Weight corrected jump power will be the main outcome variable. Countermovement jumps are performed on a Leonardo force plate (Novotec Medical, Pforzheim, Germany) following standard procedures. Jumping mechanography uses maximal countermovement jumps to quantitatively measure muscle strength in the legs. Participants will be asked to perform three countermovement jumps. Participants are asked to try to jump as high as possible using both legs. Three jumps are performed; the jump with the highest jump height is used for analysis.

    This was collected 4 times: Baseline, after 8 week loading/loading+ vibration training, after 4 week washout, after 8 week crossover training.

Secondary Outcomes (6)

  • Grip Strength

    Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.

  • Gait Speed

    Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.

  • Sway

    Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.

  • Short Physical Performance Battery (SPPB)

    Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.

  • Timed-Up-and-Go (TUG)

    Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.

  • +1 more secondary outcomes

Other Outcomes (2)

  • Adherence and Factors That Influence Adherence-Exercise Enjoyment

    This was collected at the end of each 8 week intervention period.

  • Adherence and Factors That Influence Adherence-Pain

    This was collected before and after training during each of the 8 week interventions.

Study Arms (2)

Combination Treatment

ACTIVE COMPARATOR

In the "loading + vibration group" (intervention group), subjects will be seated in the VibeTech One system and vibratory acceleration will be 30Hz and the applied load will be 50% of body weight up to a device maximum applied load of 100 lbs. Vibration intensity will initially be set to 0.2 g and will increase by 0.2 g every other week, as tolerated by the subject, and max out at 1.0 g.

Device: VibeTech One

Sham Treatment

SHAM COMPARATOR

In the "loading only" group (control group) participants will be seated in the vibration device (VibeTech One) and will experience loading of their leg muscles through the device.

Device: VibeTech One

Interventions

Vibration Training The VibeTech One Rehab Chair allows vibration exercise while seated. A force is applied on a footplate that simulates the weight of standing or partial bodyweight. The participants will train for 10 minutes 3 days per week. In the "loading + vibration group" (intervention group) vibratory acceleration will be 30Hz and the applied load will be 50% of body weight up to a device maximum applied load of 100 lbs. Vibration intensity will initially be set to 0.2 g and will increase by 0.2 g every other week, as tolerated by the subject, and max out at 1.0 g.

Combination TreatmentSham Treatment

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Men and women age ≥ 70 years
  • Able and willing to sign informed consent
  • Able to stand without assistance
  • Able and willing to train for 10 minutes, 3 times per week
  • Total SPPB score of ≤ 9 or ≤ 2 in any of the three tests included in the SPPB

You may not qualify if:

  • Cognitive impairment to the degree that it limits the ability of signing informed consent
  • Unable to sit upright for 10 minutes
  • History of injury or surgery within the prior six months which limits the ability to ambulate
  • Major illness that might cause missed training sessions or visits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jewish Home and Care Center

Milwaukee, Wisconsin, 53202, United States

Location

Related Publications (1)

  • Taani MH, Binkley N, Gangnon R, Krueger D, Buehring B. Effect of semi-recumbent vibration exercise on muscle outcomes in older adults: a pilot randomized controlled clinical trial. BMC Geriatr. 2022 Apr 18;22(1):335. doi: 10.1186/s12877-022-03052-0.

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Results Point of Contact

Title
Diane Krueger
Organization
University of Wisconsin

Study Officials

  • Bjoern Buehring, M.D.

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2015

First Posted

August 26, 2015

Study Start

November 1, 2015

Primary Completion

February 15, 2017

Study Completion

February 15, 2017

Last Updated

April 2, 2019

Results First Posted

April 2, 2019

Record last verified: 2019-03

Locations