Semi-Recumbent Vibration Therapy in Older Adults
Primary Purpose
Sarcopenia, Aging
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VibeTech One
Sponsored by
About this trial
This is an interventional treatment trial for Sarcopenia
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Jewish Home and Care Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Combination Treatment
Sham Treatment
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Grip Strength
Grip Strengthwas acquired using a JAMAR hand dynamometer in the routine clinical manner. Measurements were recorded using participants' non-dominant hand and repeated 3 times to determine maximum grip strength.
Gait Speed
Gait speed will be measured by instructing participants to walk four meters at their normal pace; they are timed with a stopwatch. This test will be repeated twice. The walk performed in the least time will be utilized for scoring purposes.
Sway
Sway is assessed by having the participants stand with feet being placed side by side for ten seconds. Participants will be wearing MobilityLabTM (APDM, Portland, OR) sensors on their chest, lower back, wrists and feet during these tests to collect computerized sway data.
Short Physical Performance Battery (SPPB)
The short physical performance battery (SPPB) consists of gait speed as determined by a four-meter walk, timed repeated chair rise and standing balance. Gait speed will be measured by instructing participants to walk four meters at their normal pace; timed with a stopwatch and is repeated twice. The walk performed in the least time will be utilized for SPPB scoring purposes. The timed repeated chair rise has participants stand up from a chair five times without the use of their arms, if possible. Time to complete five stands is measured. Standing balance is assessed by having the participants stand in three positions of increasing difficulty for 10 seconds each. Standardized instructions will be given to all participants and the test performed twice. The SPPB will be conducted and scored in standard manner, score 0-12, with lower scores indicating mobility limitations. Participants will be wearing MobilityLabTM sensors to collect computerized data for these tests.
Timed-Up-and-Go (TUG)
The Timed-Up-and-Go (TUG) test will be performed twice; participants will be seated in an armless chair, upon instruction, they will be asked to stand, which starts the timing, they will walk 3 meters past a mark on the floor at their normal pace, turn around and return to a full seated position, at which time the test will end.
Bioelectrical Impedance Spectroscopy (BIS)
An ImpediMed SFB7 device (Eight Mile Plains, Queensland, Australia) will be used to obtain these measurements. Participants will be positioned supine for a minimum of 10 minutes prior to acquisition; adequate separation of their legs will be obtained to allow for accurate BIS measurement. Measurements will be obtained by placing four EKG-like electrodes on the skin of the participant's hand, feet and knee. Wires will be attached from the BIS device to these skin electrodes. Painless electric waves will be sent through the tissues as noted above. Each measurement lasts only a few seconds. This method will generate measurements of lean mass.
Full Information
NCT ID
NCT02533063
First Posted
August 19, 2015
Last Updated
March 8, 2019
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT02533063
Brief Title
Semi-Recumbent Vibration Therapy in Older Adults
Official Title
Semi-Recumbent Vibration Therapy in Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
February 15, 2017 (Actual)
Study Completion Date
February 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
There are four study visits; screening/baseline followed by eight weeks of training three times a week, visit 1 at eight weeks followed by 4 weeks of washout, Visit 2 at 12 weeks followed by eight weeks of training three times a week, and a final Visit 3 at 20 weeks.
At the screening visit, volunteers will be asked to perform tests included in the short physical performance battery (SPPB) (gait speed, chair rise, balance). If the participants score is ≤ 9 or ≤ 2 in any of the three tests included in the SPPB they will be eligible for the intervention phase. At the baseline visit several questionnaires will be obtained and participants then will proceed with muscle function tests (SPPB, jumping mechanography, grip strength, timed-up-and-go test).
Participants will then be randomized into one of two groups. The first group will receive vibration + loading treatment for the first 8 weeks, the second group will receive sham treatment (loading only). After 8 weeks both groups will go through a 4 week wash-out period and then crossover will occur. The first group will now receive sham treatment (loading only) while the second group will receive vibration + loading treatment. The participants will train for 10 minutes, 3 times a week, during the active 16 total weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Aging
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Combination Treatment
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sham Treatment
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
VibeTech One
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight Corrected Jump Power Based on Participant's Jump on the Jump Force Plate
Description
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.
Time Frame
This was collected 4 times: Baseline, after 8 week loading/loading+ vibration training, after 4 week washout, after 8 week crossover training.
Secondary Outcome Measure Information:
Title
Grip Strength
Description
Grip Strengthwas acquired using a JAMAR hand dynamometer in the routine clinical manner. Measurements were recorded using participants' non-dominant hand and repeated 3 times to determine maximum grip strength.
Time Frame
Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.
Title
Gait Speed
Description
Gait speed will be measured by instructing participants to walk four meters at their normal pace; they are timed with a stopwatch. This test will be repeated twice. The walk performed in the least time will be utilized for scoring purposes.
Time Frame
Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.
Title
Sway
Description
Sway is assessed by having the participants stand with feet being placed side by side for ten seconds. Participants will be wearing MobilityLabTM (APDM, Portland, OR) sensors on their chest, lower back, wrists and feet during these tests to collect computerized sway data.
Time Frame
Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.
Title
Short Physical Performance Battery (SPPB)
Description
The short physical performance battery (SPPB) consists of gait speed as determined by a four-meter walk, timed repeated chair rise and standing balance. Gait speed will be measured by instructing participants to walk four meters at their normal pace; timed with a stopwatch and is repeated twice. The walk performed in the least time will be utilized for SPPB scoring purposes. The timed repeated chair rise has participants stand up from a chair five times without the use of their arms, if possible. Time to complete five stands is measured. Standing balance is assessed by having the participants stand in three positions of increasing difficulty for 10 seconds each. Standardized instructions will be given to all participants and the test performed twice. The SPPB will be conducted and scored in standard manner, score 0-12, with lower scores indicating mobility limitations. Participants will be wearing MobilityLabTM sensors to collect computerized data for these tests.
Time Frame
Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.
Title
Timed-Up-and-Go (TUG)
Description
The Timed-Up-and-Go (TUG) test will be performed twice; participants will be seated in an armless chair, upon instruction, they will be asked to stand, which starts the timing, they will walk 3 meters past a mark on the floor at their normal pace, turn around and return to a full seated position, at which time the test will end.
Time Frame
Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.
Title
Bioelectrical Impedance Spectroscopy (BIS)
Description
An ImpediMed SFB7 device (Eight Mile Plains, Queensland, Australia) will be used to obtain these measurements. Participants will be positioned supine for a minimum of 10 minutes prior to acquisition; adequate separation of their legs will be obtained to allow for accurate BIS measurement. Measurements will be obtained by placing four EKG-like electrodes on the skin of the participant's hand, feet and knee. Wires will be attached from the BIS device to these skin electrodes. Painless electric waves will be sent through the tissues as noted above. Each measurement lasts only a few seconds. This method will generate measurements of lean mass.
Time Frame
Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.
Other Pre-specified Outcome Measures:
Title
Adherence and Factors That Influence Adherence-Exercise Enjoyment
Description
Exercise enjoyment for each intervention was assessed using the validated questionnaire, "5-point Likert scale." Response options include "strongly agree", "agree", "neutral", "disagree", "strongly agree".
Time Frame
This was collected at the end of each 8 week intervention period.
Title
Adherence and Factors That Influence Adherence-Pain
Description
Self-reported pre- and post-training pain during the vibration intervention and control sessions were calculated as the mean for each participant using a validated questionnaire, "Comprehensive Pain Assessment Form" with scale from 0-10, 0 being no pain and 10 being severe pain.
Time Frame
This was collected before and after training during each of the 8 week interventions.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bjoern Buehring, M.D.
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jewish Home and Care Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53202
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35436920
Citation
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.
Results Reference
derived
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Semi-Recumbent Vibration Therapy in Older Adults
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