Semi-Recumbent Vibration Therapy in Older Adults

Aging Clinical Trial

Official title:

Semi-Recumbent Vibration Therapy in Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02533063
• Other study ID #: 2015-0480
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: February 15, 2017

Study information

• Verified date: March 2019
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 15, 2017
• Est. primary completion date: February 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aging
• Sarcopenia

Intervention

Device:
• VibeTech 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.

Locations

Country	Name	City	State
United States	Jewish Home and Care Center	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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".	This was collected at the end of each 8 week intervention period.
Other	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.	This was collected before and after training during each of the 8 week interventions.
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.	This was collected 4 times: Baseline, after 8 week loading/loading+ vibration training, after 4 week washout, after 8 week crossover training.
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.	Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.
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.	Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.
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.	Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.
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.	Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.
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.	Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.
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.	Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.