Trial Outcomes & Findings for Semi-Recumbent Vibration Therapy in Older Adults (NCT NCT02533063)
NCT ID: NCT02533063
Last Updated: 2019-04-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
This was collected 4 times: Baseline, after 8 week loading/loading+ vibration training, after 4 week washout, after 8 week crossover training.
Results posted on
2019-04-02
Participant Flow
Participant milestones
| Measure |
Loading + Vibration, Then Loading Only
In "Loading + Vibration" phase, subjects will be seated in the VibeTech One Rehab Chair, which 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. The 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 of 1.0 g.
In "Loading Only" phase participants will be seated in the vibration device (VibeTech One) and will experience loading of their leg muscles through the device with no vibration.
There will be a four week washout period between the two interventions.
|
Loading Only, Then Loading + Vibration
In "Loading + Vibration" phase, subjects will be seated in the VibeTech One Rehab Chair, which 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. The 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 of 1.0 g.
In "Loading Only" phase participants will be seated in the vibration device (VibeTech One) and will experience loading of their leg muscles through the device with no vibration.
There will be a four week washout period between the two interventions.
|
|---|---|---|
|
Intervention 1 (8 Weeks)
STARTED
|
16
|
16
|
|
Intervention 1 (8 Weeks)
COMPLETED
|
14
|
11
|
|
Intervention 1 (8 Weeks)
NOT COMPLETED
|
2
|
5
|
|
Washout (4 Weeks)
STARTED
|
14
|
11
|
|
Washout (4 Weeks)
COMPLETED
|
14
|
11
|
|
Washout (4 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Intervention 2 (8 Weeks)
STARTED
|
14
|
11
|
|
Intervention 2 (8 Weeks)
COMPLETED
|
14
|
11
|
|
Intervention 2 (8 Weeks)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Semi-Recumbent Vibration Therapy in Older Adults
Baseline characteristics by cohort
| Measure |
Loading + Vibration, Then Loading Only
n=16 Participants
In "Loading + Vibration" intervention phase, subjects will be seated in the VibeTech One Rehab Chair, which 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. The 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 of 1.0 g.
In "Loading Only" control phase participants will be seated in the vibration device (VibeTech One) and will experience loading of their leg muscles through the device with no vibration.
|
Loading Only, Then Loading + Vibration
n=16 Participants
In "Loading + Vibration" intervention phase, subjects will be seated in the VibeTech One Rehab Chair, which 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. The 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 of 1.0 g.
In "Loading Only" control phase participants will be seated in the vibration device (VibeTech One) and will experience loading of their leg muscles through the device with no vibration.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
|
Age, Continuous
|
87.9 years
n=93 Participants
|
86.9 years
n=4 Participants
|
87.4 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: This was collected 4 times: Baseline, after 8 week loading/loading+ vibration training, after 4 week washout, after 8 week crossover training.Population: In this frail population a number of individuals were unable to perform satisfactory jumps to collect valid data with the current software.
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.
Outcome measures
| Measure |
Loading + Vibration
n=13 Participants
In "Loading + Vibration" intervention phase, subjects will be seated in the VibeTech One Rehab Chair, which 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. The 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 of 1.0 g.
There will be a four week washout period between the two interventions.
|
Loading Only
n=13 Participants
In "Loading Only" control phase participants will be seated in the vibration device (VibeTech One) and will experience loading of their leg muscles through the device with no vibration. 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.
There will be a four week washout period between the two interventions.
|
|---|---|---|
|
Weight Corrected Jump Power Based on Participant's Jump on the Jump Force Plate
Pre Intervention
|
10.53 W/kg
Standard Deviation 5.66
|
10.28 W/kg
Standard Deviation 7.11
|
|
Weight Corrected Jump Power Based on Participant's Jump on the Jump Force Plate
Post Intervention
|
11.10 W/kg
Standard Deviation 7.03
|
8.98 W/kg
Standard Deviation 5.33
|
SECONDARY outcome
Timeframe: Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.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.
Outcome measures
| Measure |
Loading + Vibration
n=25 Participants
In "Loading + Vibration" intervention phase, subjects will be seated in the VibeTech One Rehab Chair, which 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. The 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 of 1.0 g.
There will be a four week washout period between the two interventions.
|
Loading Only
n=25 Participants
In "Loading Only" control phase participants will be seated in the vibration device (VibeTech One) and will experience loading of their leg muscles through the device with no vibration. 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.
There will be a four week washout period between the two interventions.
|
|---|---|---|
|
Grip Strength
Pre Intervention
|
13.8 Force (kg)
Standard Deviation 6.0
|
12.9 Force (kg)
Standard Deviation 5.6
|
|
Grip Strength
Post Intervention
|
13.3 Force (kg)
Standard Deviation 6.4
|
14.1 Force (kg)
Standard Deviation 5.0
|
SECONDARY outcome
Timeframe: Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.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.
Outcome measures
| Measure |
Loading + Vibration
n=25 Participants
In "Loading + Vibration" intervention phase, subjects will be seated in the VibeTech One Rehab Chair, which 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. The 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 of 1.0 g.
There will be a four week washout period between the two interventions.
|
Loading Only
n=25 Participants
In "Loading Only" control phase participants will be seated in the vibration device (VibeTech One) and will experience loading of their leg muscles through the device with no vibration. 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.
There will be a four week washout period between the two interventions.
|
|---|---|---|
|
Gait Speed
Pre Intervention
|
0.6 Speed (m/sec)
Standard Deviation 0.2
|
0.7 Speed (m/sec)
Standard Deviation 0.2
|
|
Gait Speed
Post Intervention
|
0.7 Speed (m/sec)
Standard Deviation 0.3
|
0.7 Speed (m/sec)
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.Population: Not all participants could complete the balance exercise and provide valid data for this measure.
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.
Outcome measures
| Measure |
Loading + Vibration
n=10 Participants
In "Loading + Vibration" intervention phase, subjects will be seated in the VibeTech One Rehab Chair, which 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. The 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 of 1.0 g.
There will be a four week washout period between the two interventions.
|
Loading Only
n=10 Participants
In "Loading Only" control phase participants will be seated in the vibration device (VibeTech One) and will experience loading of their leg muscles through the device with no vibration. 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.
There will be a four week washout period between the two interventions.
|
|---|---|---|
|
Sway
Pre Intervention
|
9.2 Area (cm square)
Standard Deviation 15.8
|
4.8 Area (cm square)
Standard Deviation 6.3
|
|
Sway
Post Intervention
|
5.8 Area (cm square)
Standard Deviation 3.4
|
4.7 Area (cm square)
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.Population: Not all participants completed the SPPB test.
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.
Outcome measures
| Measure |
Loading + Vibration
n=21 Participants
In "Loading + Vibration" intervention phase, subjects will be seated in the VibeTech One Rehab Chair, which 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. The 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 of 1.0 g.
There will be a four week washout period between the two interventions.
|
Loading Only
n=21 Participants
In "Loading Only" control phase participants will be seated in the vibration device (VibeTech One) and will experience loading of their leg muscles through the device with no vibration. 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.
There will be a four week washout period between the two interventions.
|
|---|---|---|
|
Short Physical Performance Battery (SPPB)
Pre Intervention
|
6.8 score on a scale
Standard Deviation 2.8
|
7.0 score on a scale
Standard Deviation 2.8
|
|
Short Physical Performance Battery (SPPB)
Post Intervention
|
6.8 score on a scale
Standard Deviation 2.8
|
7.0 score on a scale
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.Population: Not all participants completed the TUG testing.
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.
Outcome measures
| Measure |
Loading + Vibration
n=20 Participants
In "Loading + Vibration" intervention phase, subjects will be seated in the VibeTech One Rehab Chair, which 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. The 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 of 1.0 g.
There will be a four week washout period between the two interventions.
|
Loading Only
n=20 Participants
In "Loading Only" control phase participants will be seated in the vibration device (VibeTech One) and will experience loading of their leg muscles through the device with no vibration. 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.
There will be a four week washout period between the two interventions.
|
|---|---|---|
|
Timed-Up-and-Go (TUG)
Pre Intervention
|
18.6 Time (seconds)
Standard Deviation 7.8
|
18.4 Time (seconds)
Standard Deviation 6.8
|
|
Timed-Up-and-Go (TUG)
Post Intervention
|
20.5 Time (seconds)
Standard Deviation 10.1
|
19.3 Time (seconds)
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.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.
Outcome measures
| Measure |
Loading + Vibration
n=21 Participants
In "Loading + Vibration" intervention phase, subjects will be seated in the VibeTech One Rehab Chair, which 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. The 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 of 1.0 g.
There will be a four week washout period between the two interventions.
|
Loading Only
n=23 Participants
In "Loading Only" control phase participants will be seated in the vibration device (VibeTech One) and will experience loading of their leg muscles through the device with no vibration. 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.
There will be a four week washout period between the two interventions.
|
|---|---|---|
|
Bioelectrical Impedance Spectroscopy (BIS)
Pre Intervention
|
41.75 Mass (kg)
Standard Deviation 7.36
|
41.86 Mass (kg)
Standard Deviation 6.34
|
|
Bioelectrical Impedance Spectroscopy (BIS)
Post Intervention
|
42.19 Mass (kg)
Standard Deviation 8.23
|
41.71 Mass (kg)
Standard Deviation 6.71
|
OTHER_PRE_SPECIFIED outcome
Timeframe: This was collected at the end of each 8 week intervention period.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".
Outcome measures
| Measure |
Loading + Vibration
n=25 Participants
In "Loading + Vibration" intervention phase, subjects will be seated in the VibeTech One Rehab Chair, which 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. The 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 of 1.0 g.
There will be a four week washout period between the two interventions.
|
Loading Only
n=25 Participants
In "Loading Only" control phase participants will be seated in the vibration device (VibeTech One) and will experience loading of their leg muscles through the device with no vibration. 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.
There will be a four week washout period between the two interventions.
|
|---|---|---|
|
Adherence and Factors That Influence Adherence-Exercise Enjoyment
Strongly agree
|
12 percentage of participants
|
0 percentage of participants
|
|
Adherence and Factors That Influence Adherence-Exercise Enjoyment
Agree to Neutral
|
40 percentage of participants
|
33 percentage of participants
|
|
Adherence and Factors That Influence Adherence-Exercise Enjoyment
Neutral
|
48 percentage of participants
|
67 percentage of participants
|
|
Adherence and Factors That Influence Adherence-Exercise Enjoyment
Disagree
|
0 percentage of participants
|
0 percentage of participants
|
|
Adherence and Factors That Influence Adherence-Exercise Enjoyment
Strongly disagree
|
0 percentage of participants
|
0 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: This was collected before and after training during each of the 8 week interventions.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.
Outcome measures
| Measure |
Loading + Vibration
n=25 Participants
In "Loading + Vibration" intervention phase, subjects will be seated in the VibeTech One Rehab Chair, which 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. The 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 of 1.0 g.
There will be a four week washout period between the two interventions.
|
Loading Only
n=25 Participants
In "Loading Only" control phase participants will be seated in the vibration device (VibeTech One) and will experience loading of their leg muscles through the device with no vibration. 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.
There will be a four week washout period between the two interventions.
|
|---|---|---|
|
Adherence and Factors That Influence Adherence-Pain
Pre-training 0-3
|
84 percentage of participants
|
96 percentage of participants
|
|
Adherence and Factors That Influence Adherence-Pain
Pre-training 4-6
|
16 percentage of participants
|
4 percentage of participants
|
|
Adherence and Factors That Influence Adherence-Pain
Pre-training 7-10
|
0 percentage of participants
|
0 percentage of participants
|
|
Adherence and Factors That Influence Adherence-Pain
Post-training 0-3
|
88 percentage of participants
|
96 percentage of participants
|
|
Adherence and Factors That Influence Adherence-Pain
Post-training 4-6
|
12 percentage of participants
|
4 percentage of participants
|
|
Adherence and Factors That Influence Adherence-Pain
Post-training 7-10
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
Loading + Vibration
Serious events: 4 serious events
Other events: 14 other events
Deaths: 0 deaths
Loading Only
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Loading + Vibration
n=32 participants at risk
In "Loading + Vibration" intervention phase, subjects will be seated in the VibeTech One Rehab Chair, which 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. The 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 of 1.0 g.
There will be a four week washout period between the two interventions.
|
Loading Only
n=32 participants at risk
In "Loading Only" ocntrol phase participants will be seated in the vibration device (VibeTech One) and will experience loading of their leg muscles through the device with no vibration. 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.
There will be a four week washout period between the two interventions.
|
|---|---|---|
|
Gastrointestinal disorders
Stomach pain
|
3.1%
1/32 • Number of events 1 • 20 weeks
|
0.00%
0/16 • 20 weeks
|
|
General disorders
Reaction to antibiotic
|
3.1%
1/32 • Number of events 1 • 20 weeks
|
0.00%
0/32 • 20 weeks
|
|
Cardiac disorders
Heart attack
|
3.1%
1/32 • Number of events 1 • 20 weeks
|
3.1%
1/32 • Number of events 1 • 20 weeks
|
|
Gastrointestinal disorders
GI Bleeding
|
3.1%
1/32 • Number of events 2 • 20 weeks
|
0.00%
0/32 • 20 weeks
|
|
Musculoskeletal and connective tissue disorders
Hip fracture
|
0.00%
0/32 • 20 weeks
|
3.1%
1/32 • Number of events 1 • 20 weeks
|
Other adverse events
| Measure |
Loading + Vibration
n=32 participants at risk
In "Loading + Vibration" intervention phase, subjects will be seated in the VibeTech One Rehab Chair, which 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. The 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 of 1.0 g.
There will be a four week washout period between the two interventions.
|
Loading Only
n=32 participants at risk
In "Loading Only" ocntrol phase participants will be seated in the vibration device (VibeTech One) and will experience loading of their leg muscles through the device with no vibration. 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.
There will be a four week washout period between the two interventions.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
37.5%
12/32 • Number of events 12 • 20 weeks
|
9.4%
3/32 • Number of events 3 • 20 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.1%
1/32 • Number of events 1 • 20 weeks
|
0.00%
0/32 • 20 weeks
|
|
Nervous system disorders
Parkinsons disease
|
0.00%
0/32 • 20 weeks
|
3.1%
1/32 • Number of events 1 • 20 weeks
|
|
Musculoskeletal and connective tissue disorders
Vertebral fracture
|
3.1%
1/32 • Number of events 1 • 20 weeks
|
0.00%
0/32 • 20 weeks
|
|
Blood and lymphatic system disorders
Blood clot
|
3.1%
1/32 • Number of events 1 • 20 weeks
|
0.00%
0/32 • 20 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place