Aging, Sarcopenia
Conditions
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.
Interventions
DEVICEVibeTech One
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.
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Men and women age ≥ 70 years 2. Able and willing to sign informed consent 3. Able to stand without assistance 4. Able and willing to train for 10 minutes, 3 times per week 5. Total SPPB score of ≤ 9 or ≤ 2 in any of the three tests included in the SPPB
Exclusion criteria
1. Cognitive impairment to the degree that it limits the ability of signing informed consent 2. Unable to sit upright for 10 minutes 3. History of injury or surgery within the prior six months which limits the ability to ambulate 4. Major illness that might cause missed training sessions or visits.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Corrected Jump Power Based on Participant's Jump on the Jump Force Plate | This was collected 4 times: Baseline, after 8 week loading/loading+ vibration training, after 4 week washout, after 8 week crossover training. | 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
| Measure | Time frame | Description |
|---|---|---|
| Grip Strength | 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. |
| Gait Speed | 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. |
| Sway | Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2. | 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. |
| Timed-Up-and-Go (TUG) | Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2. | 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) | 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. |
| Short Physical Performance Battery (SPPB) | Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2. | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adherence and Factors That Influence Adherence-Exercise Enjoyment | 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. |
| Adherence and Factors That Influence Adherence-Pain | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Loading + Vibration, Then Loading Only 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. | 16 |
| Loading Only, Then Loading + Vibration 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. | 16 |
| Total | 32 |
Baseline characteristics
| Characteristic | Loading + Vibration, Then Loading Only | Loading Only, Then Loading + Vibration | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 16 Participants | 16 Participants | 32 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 87.9 years | 86.9 years | 87.4 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 16 Participants | 32 Participants |
| Region of Enrollment United States | 16 Participants | 16 Participants | 32 Participants |
| Sex: Female, Male Female | 10 Participants | 13 Participants | 23 Participants |
| Sex: Female, Male Male | 6 Participants | 3 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 32 |
| other Total, other adverse events | 14 / 32 | 3 / 32 |
| serious Total, serious adverse events | 4 / 32 | 2 / 32 |
Outcome results
Primary
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Loading + Vibration | Weight Corrected Jump Power Based on Participant's Jump on the Jump Force Plate | Pre Intervention | 10.53 W/kg | Standard Deviation 5.66 |
| Loading + Vibration | Weight Corrected Jump Power Based on Participant's Jump on the Jump Force Plate | Post Intervention | 11.10 W/kg | Standard Deviation 7.03 |
| Loading Only | Weight Corrected Jump Power Based on Participant's Jump on the Jump Force Plate | Pre Intervention | 10.28 W/kg | Standard Deviation 7.11 |
| Loading Only | Weight Corrected Jump Power Based on Participant's Jump on the Jump Force Plate | Post Intervention | 8.98 W/kg | Standard Deviation 5.33 |
p-value: 0.217ANOVA
Secondary
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.
Time frame: Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Loading + Vibration | Bioelectrical Impedance Spectroscopy (BIS) | Pre Intervention | 41.75 Mass (kg) | Standard Deviation 7.36 |
| Loading + Vibration | Bioelectrical Impedance Spectroscopy (BIS) | Post Intervention | 42.19 Mass (kg) | Standard Deviation 8.23 |
| Loading Only | Bioelectrical Impedance Spectroscopy (BIS) | Pre Intervention | 41.86 Mass (kg) | Standard Deviation 6.34 |
| Loading Only | Bioelectrical Impedance Spectroscopy (BIS) | Post Intervention | 41.71 Mass (kg) | Standard Deviation 6.71 |
p-value: 0.483ANOVA
Secondary
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.
Time frame: Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Loading + Vibration | Gait Speed | Pre Intervention | 0.6 Speed (m/sec) | Standard Deviation 0.2 |
| Loading + Vibration | Gait Speed | Post Intervention | 0.7 Speed (m/sec) | Standard Deviation 0.3 |
| Loading Only | Gait Speed | Pre Intervention | 0.7 Speed (m/sec) | Standard Deviation 0.2 |
| Loading Only | Gait Speed | Post Intervention | 0.7 Speed (m/sec) | Standard Deviation 0.2 |
p-value: 0.151ANOVA
Secondary
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.
Time frame: Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Loading + Vibration | Grip Strength | Pre Intervention | 13.8 Force (kg) | Standard Deviation 6 |
| Loading + Vibration | Grip Strength | Post Intervention | 13.3 Force (kg) | Standard Deviation 6.4 |
| Loading Only | Grip Strength | Pre Intervention | 12.9 Force (kg) | Standard Deviation 5.6 |
| Loading Only | Grip Strength | Post Intervention | 14.1 Force (kg) | Standard Deviation 5 |
p-value: 0.501ANOVA
Secondary
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.
Time frame: Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.
Population: Not all participants completed the SPPB test.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Loading + Vibration | Short Physical Performance Battery (SPPB) | Pre Intervention | 6.8 score on a scale | Standard Deviation 2.8 |
| Loading + Vibration | Short Physical Performance Battery (SPPB) | Post Intervention | 6.8 score on a scale | Standard Deviation 2.8 |
| Loading Only | Short Physical Performance Battery (SPPB) | Pre Intervention | 7.0 score on a scale | Standard Deviation 2.8 |
| Loading Only | Short Physical Performance Battery (SPPB) | Post Intervention | 7.0 score on a scale | Standard Deviation 3 |
p-value: 0.678ANOVA
Secondary
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Loading + Vibration | Sway | Pre Intervention | 9.2 Area (cm square) | Standard Deviation 15.8 |
| Loading + Vibration | Sway | Post Intervention | 5.8 Area (cm square) | Standard Deviation 3.4 |
| Loading Only | Sway | Pre Intervention | 4.8 Area (cm square) | Standard Deviation 6.3 |
| Loading Only | Sway | Post Intervention | 4.7 Area (cm square) | Standard Deviation 4.2 |
p-value: 0.45ANOVA
Secondary
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.
Time frame: Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.
Population: Not all participants completed the TUG testing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Loading + Vibration | Timed-Up-and-Go (TUG) | Pre Intervention | 18.6 Time (seconds) | Standard Deviation 7.8 |
| Loading + Vibration | Timed-Up-and-Go (TUG) | Post Intervention | 20.5 Time (seconds) | Standard Deviation 10.1 |
| Loading Only | Timed-Up-and-Go (TUG) | Pre Intervention | 18.4 Time (seconds) | Standard Deviation 6.8 |
| Loading Only | Timed-Up-and-Go (TUG) | Post Intervention | 19.3 Time (seconds) | Standard Deviation 8.4 |
p-value: 0.06ANOVA
Other Pre-specified
Adherence and Factors That Influence Adherence-Exercise Enjoyment
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Loading + Vibration | Adherence and Factors That Influence Adherence-Exercise Enjoyment | Agree to Neutral | 40 percentage of participants |
| Loading + Vibration | Adherence and Factors That Influence Adherence-Exercise Enjoyment | Disagree | 0 percentage of participants |
| Loading + Vibration | Adherence and Factors That Influence Adherence-Exercise Enjoyment | Neutral | 48 percentage of participants |
| Loading + Vibration | Adherence and Factors That Influence Adherence-Exercise Enjoyment | Strongly disagree | 0 percentage of participants |
| Loading + Vibration | Adherence and Factors That Influence Adherence-Exercise Enjoyment | Strongly agree | 12 percentage of participants |
| Loading Only | Adherence and Factors That Influence Adherence-Exercise Enjoyment | Strongly disagree | 0 percentage of participants |
| Loading Only | Adherence and Factors That Influence Adherence-Exercise Enjoyment | Strongly agree | 0 percentage of participants |
| Loading Only | Adherence and Factors That Influence Adherence-Exercise Enjoyment | Agree to Neutral | 33 percentage of participants |
| Loading Only | Adherence and Factors That Influence Adherence-Exercise Enjoyment | Neutral | 67 percentage of participants |
| Loading Only | Adherence and Factors That Influence Adherence-Exercise Enjoyment | Disagree | 0 percentage of participants |
Other Pre-specified
Adherence and Factors That Influence Adherence-Pain
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Loading + Vibration | Adherence and Factors That Influence Adherence-Pain | Pre-training 0-3 | 84 percentage of participants |
| Loading + Vibration | Adherence and Factors That Influence Adherence-Pain | Pre-training 4-6 | 16 percentage of participants |
| Loading + Vibration | Adherence and Factors That Influence Adherence-Pain | Pre-training 7-10 | 0 percentage of participants |
| Loading + Vibration | Adherence and Factors That Influence Adherence-Pain | Post-training 0-3 | 88 percentage of participants |
| Loading + Vibration | Adherence and Factors That Influence Adherence-Pain | Post-training 4-6 | 12 percentage of participants |
| Loading + Vibration | Adherence and Factors That Influence Adherence-Pain | Post-training 7-10 | 0 percentage of participants |
| Loading Only | Adherence and Factors That Influence Adherence-Pain | Post-training 4-6 | 4 percentage of participants |
| Loading Only | Adherence and Factors That Influence Adherence-Pain | Pre-training 0-3 | 96 percentage of participants |
| Loading Only | Adherence and Factors That Influence Adherence-Pain | Post-training 0-3 | 96 percentage of participants |
| Loading Only | Adherence and Factors That Influence Adherence-Pain | Pre-training 4-6 | 4 percentage of participants |
| Loading Only | Adherence and Factors That Influence Adherence-Pain | Post-training 7-10 | 0 percentage of participants |
| Loading Only | Adherence and Factors That Influence Adherence-Pain | Pre-training 7-10 | 0 percentage of participants |