Balance Training for Elders With Heart Failure (BASIC)

• ClinicalTrials.gov Identifier: NCT02566785
• Recruitment Status: Completed
• First Posted: October 2, 2015
• Results First Posted: October 9, 2018
• Last Update Posted: October 9, 2018
• Sponsor: University of Nebraska
• Collaborator: American Nurses Foundation
• Information provided by (Responsible Party): Rita L. McGuire, PhD, RN, University of Nebraska

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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].

Contacts and Locations

Locations

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

More Information

• Responsible Party: Rita L. McGuire, PhD, RN, Principal Investigator, University of Nebraska
• ClinicalTrials.gov Identifier: NCT02566785
• Other Study ID Numbers: 677-15-FB
• First Posted: October 2, 2015
• Results First Posted: October 9, 2018
• Last Update Posted: October 9, 2018
• Last Verified: July 2017

Additional relevant MeSH terms:

Heart Failure; Heart Diseases; Cardiovascular Diseases