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Balance Training for Elders With Heart Failure (BASIC)

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ClinicalTrials.gov Identifier: NCT02566785
Recruitment Status : Completed
First Posted : October 2, 2015
Results First Posted : October 8, 2018
Last Update Posted : October 8, 2018
Sponsor:
Collaborator:
American Nurses Foundation
Information provided by (Responsible Party):
Rita L. McGuire, PhD, RN, University of Nebraska

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Heart Failure Other: Balance Intervention Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Balance Activities and Strengthening to Improve Condition [BASIC]: Training for Elders With Heart Failure
Study Start Date : February 2016
Actual Primary Completion Date : December 16, 2016
Actual Study Completion Date : December 16, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Intervention Group
Those allocated to the intervention group will participate in a supervised group session exercise one time per week and be asked to exercise two more times per week at home.
Other: Balance Intervention
The multi-component balance intervention will be 1x per week in supervised group sessions and 2x a week sessions at home. Sessions will begin with a 5 minute warm up of major muscle groups using flexibility exercises and end with a cool down. Sessions will focus on improving static balance in the initial stages, then progress to dynamic balance.

Wait List Control Group
The wait list control group will not participate in the intervention and will be asked to continue their usual activity level during the first 12 weeks and will receive the multi-component balance intervention during weeks 12-24.
Other: Balance Intervention
The multi-component balance intervention will be 1x per week in supervised group sessions and 2x a week sessions at home. Sessions will begin with a 5 minute warm up of major muscle groups using flexibility exercises and end with a cool down. Sessions will focus on improving static balance in the initial stages, then progress to dynamic balance.




Primary Outcome Measures :
  1. Pre/Post Scores on the 30 Second Sit to Stand Test Will be Used to Detect Any Changes in Leg Strength and Endurance That Occur During the 12 Week Group Exercise Sessions. [ Time Frame: Baseline and 12 weeks ]
  2. Dynamic Gait Index [ Time Frame: Baseline and 12 weeks ]
    8 increasingly challenging walking tasks (normal gait speed, changes in gait speed, walking with horizontal and vertical head movements, walking with pivot turn, walking over and around obstacles and stair climbing). A walkway path measured at 20 feet was used. A research assistance observed and scored all participants using a 0-3 scale, 0 = severe gait impairment, 1 = moderate gait impairment, 2 = mild/minimal impairment, 3 = normal gait, with a total possible scale range of 0 to 24 points. Scores ≤ 19 points was used to classify falling risk (Shumway-Cook et al. 1997).


Secondary Outcome Measures :
  1. Activity Balance Confidence Scale [ Time Frame: Baseline and 12 weeks ]
    Total range = 0-100% Higher values represent better outcome Total score is averaged = total%/16 responses



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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].

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02566785


Locations
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United States, Nebraska
University of Nebraska Medical Center College of Nursing
Lincoln, Nebraska, United States, 68588-0220
Sponsors and Collaborators
University of Nebraska
American Nurses Foundation

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Responsible Party: Rita L. McGuire, PhD, RN, Principal Investigator, University of Nebraska
ClinicalTrials.gov Identifier: NCT02566785     History of Changes
Other Study ID Numbers: 677-15-FB
First Posted: October 2, 2015    Key Record Dates
Results First Posted: October 8, 2018
Last Update Posted: October 8, 2018
Last Verified: July 2017
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases