Clinical trial NCT02533063: Semi-Recumbent Vibration Therapy in Older Adults
Official title: Semi-Recumbent Vibration Therapy in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Aging
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2015-08-26
Enrollment: 32
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Weight Corrected Jump Power Based on Participant's Jump on the Jump Force Plate
timeFrame: This was collected 4 times: Baseline, after 8 week loading/loading+ vibration training, after 4 week washout, after 8 week crossover training.
Secondary outcomes:
measure: Grip Strength
timeFrame: Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.
measure: Gait Speed
timeFrame: Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.
measure: Sway
timeFrame: Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.
measure: Short Physical Performance Battery (SPPB)
timeFrame: Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.
measure: Timed-Up-and-Go (TUG)
timeFrame: Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.
measure: Bioelectrical Impedance Spectroscopy (BIS)
timeFrame: Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.
Other outcomes:
measure: Adherence and Factors That Influence Adherence-Exercise Enjoyment
timeFrame: This was collected at the end of each 8 week intervention period.
measure: Adherence and Factors That Influence Adherence-Pain
timeFrame: This was collected before and after training during each of the 8 week interventions.
Locations:
city: Milwaukee
country: United States
facility: Jewish Home and Care Center
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Bjoern Buehring, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.