Balance Training for Elders With Heart Failure



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:65 - Any
Updated:10/10/2018
Start Date:February 2016
End Date:December 16, 2016

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Balance Activities and Strengthening to Improve Condition [BASIC]: Training for Elders With Heart Failure

Purpose: The purpose of this pilot study is to evaluate the effect of a multi-component
balance & resistance training [RT] intervention on physical function, balance, & falls in
older [≥ 65 y/o] community dwelling heart failure [HF] patients. The study aims: 1] Pilot
test multi-component balance activities & RT intervention on primary outcomes. 2] Explore
perceptions related to outcomes & the intervention through focus groups. 3] Generate pilot
data on adherence. 4] Generate pilot data on feasibility of conducting the BASIC Training
intervention.

Background/Significance: Falls are the leading cause of injury-related deaths in this group.
Fall risks are even greater for those with HF due to decreased exercise capacity, loss of
skeletal muscle & medication side effects. Though RT is effective for improving skeletal
muscle, it has only a modest effect on improving balance, which is comprised of peripheral
sensory input central integration, & motor output. A multi-component intervention focusing on
balance retraining & strengthening the muscles supporting static/dynamic balance & functional
mobility is necessary.

Methods: Design - Randomized, two-group with wait list control, repeated measures
experimental design. Sample/ Setting - 40-50 participants recruited from medical center heart
failure clinic; supervised group sessions conducted in center's health & wellness center.
Procedures - Participants will be randomized to intervention group or wait list control
group. Focus groups pre/post intervention. The intervention will be administered in 1x per
week supervised group sessions & 2x a week home sessions. Instruments - 30 Second Sit-to-St&,
Modified Clinical Test of Sensory Interaction on Balance, Activity Specific Balance
Confidence Scale, Timed Up & Go, Dynamic Gait Index.

Analysis Plan: Aim 1- independent t-test to compare change scores from baseline to the end of
the first 12 week period for the intervention group with the wait list control group. A
second analysis will combine data from the delayed intervention period for the wait list
control group with that from the first 12 week period for the intervention group to test
change. Supplemental analysis, involving only data from intervention group, will test whether
change is sustained at 24 weeks. Aim 2 - thematic analysis conducted with focus group data.
Aim 3 - adherence assessed by group session attendance & home activities completed. Aim 4 -
assess & report logistics of conducting the study.

Nursing Relevance/Implications: This pilot study will initiate the process of developing a
targeted intervention to induce changes in elderly HF patients to prevent future falls; thus
reducing costs, physical & emotional burdens related to falls; & effect a major difference in
the quality of life for this population.

Purpose: The purpose of this pilot study is to evaluate the effect of a multi-component
balance and resistance training [RT] intervention on physical function, balance, and falls in
older [≥ 65 y/o] community dwelling heart failure [HF] patients. The study aims: 1] Pilot
test multi-component balance activities and RT intervention on primary outcomes. 2] Explore
perceptions related to outcomes and the intervention through focus groups. 3] Generate pilot
data on adherence. 4] Generate pilot data on feasibility of conducting the BASIC Training
intervention.

Background/Significance: Falls are the leading cause of injury-related deaths in this age
group. Fall risks are even greater for those with HF due to decreased exercise capacity, loss
of skeletal muscle and medication side effects. Though RT is effective for improving skeletal
muscle, it has only a modest effect on improving balance, which is comprised of peripheral
sensory input central integration, and motor output. A multi-component intervention focusing
on balance retraining and strengthening the muscles supporting static/dynamic balance and
functional mobility is necessary.

Methods: Design - Randomized, two-group with wait list control, repeated measures
experimental design. Sample/ Setting - 40-50 participants recruited from a medical center
heart failure clinic; supervised group sessions conducted in the center's health and wellness
center. Procedures - Participants will be randomized to the intervention group or the wait
list control group. Focus groups pre/post intervention. The intervention will be administered
in 1x per week supervised group sessions and 2x a week home sessions. Instruments - 30 Second
Sit-to-Stand, Modified Clinical Test of Sensory Interaction on Balance, Activity Specific
Balance Confidence Scale, Timed Up and Go, Dynamic Gait Index.

Analysis Plan: Aim 1- independent t-test to compare change scores from baseline to the end of
the first 12 week period for the intervention group with the wait list control group. A
second analysis will combine data from the delayed intervention period for the wait list
control group with that from the first 12 week period for the intervention group to test
change. Supplemental analysis, involving only data from intervention group, will test whether
change is sustained at 24 weeks. Aim 2 - thematic analysis conducted with focus group data.
Aim 3 - adherence assessed by group session attendance and home activities completed. Aim 4 -
assess and report logistics of conducting the study.

Nursing Relevance/Implications: This pilot study will initiate the process of developing a
targeted intervention to induce changes in elderly HF patients to prevent future falls; thus
reducing costs, physical and emotional burdens related to falls; and effect a major
difference in the quality of life for this population.

Inclusion Criteria:

- 65 years of age or greater;

- New York Heart Association class II and III,

- community dwelling;

- able to speak and read English,

- must have written permission from cardiologist to participate.

Exclusion Criteria:

- wheel chair dependency;

- history of significant residual neurologic deficits [e.g.: recent stroke];

- recent history of whiplash or concurrent complaints of neck pain;

- recent fracture or lower extremity surgery. Participants will be screened for
cognitive dysfunction and must pass the Mini-Mental State Examination [with a score at
or above 23 points].
We found this trial at
1
site
Lincoln, Nebraska 68588
Principal Investigator: Rita L McGuire, PhD Nursing
Phone: 402-472-3683
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mi
from
Lincoln, NE
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