Semi-Recumbent Vibration Therapy in Older Adults

University of Wisconsin (UW)

Status: Completed

Conditions: Aging; Sarcopenia

Treatments: Device: VibeTech One

Study type: Interventional

Funder types: Other

Identifiers

NCT02533063

2015-0480

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 70+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Combination Treatment

Active Comparator group

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.

Treatment:

Device: VibeTech One

Sham Treatment

Sham Comparator group

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.

Treatment:

Device: VibeTech One