An interventional study of Balance Intervention in Heart Failure, sponsored by University of Nebraska. Completed at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2023-09-25.
Sponsored by University of Nebraska · Not applicable, Interventional, and Treatment
Falls are the leading cause of injury-related deaths in older (≥ 65 y/) community dwelling heart failure (HF) patients. Fall risks are even greater for those with HF due to decreased exercise capacity, loss of skeletal muscle \& medication side effects. Though resistance training (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.
This pilot study will evaluate the effect of a multi-component balance \& RT intervention on physical function, balance, \& falls in older (≥ 65 y/) community dwelling heart failure (HF) patients. The study will also explore perceptions related to outcomes \& the intervention through focus groups, generate data on adherence and generate data on feasibility of conducting the BASIC Training intervention. The results of this study will be used to develop 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.
The study will be once per week supervised group sessions \& twice a week home sessions, and include 30 Second Sit-to-Stand, Modified Clinical Test of Sensory Interaction on Balance, Activity Specific Balance Confidence Scale, Timed Up \& Go, Dynamic Gait Index.
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 33 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →University of Nebraska is the lead sponsor of 473 studies on the registry; 66 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 46 (61%) have results posted.
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Exclusion Criteria:
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 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.
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
Dynamic Gait Index
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).
Time frame: Baseline and 12 weeks
Activity Balance Confidence Scale
Total range = 0-100% Higher values represent better outcome Total score is averaged = total%/16 responses
Time frame: Baseline and 12 weeks
November 2015 through June 2016 at the Heart Failure Improvement Program of a regional hospital.
| Milestone | Intervention Group | Wait List Control Group |
|---|---|---|
| Started | 15 | 18 |
| Completed | 14 | 15 |
| Not completed | 1 | 3 |
| Withdrew: Lost to follow-up | 0 | 2 |
| Withdrew: Worsening condition | 1 | 1 |
| number of sit to stand cycles | Intervention Group | Wait List Control Group |
|---|---|---|
| Baseline | 6.9 ± 4.2 | 6.5 ± 3.6 |
| 12 Weeks | 7.9 ± 4.5 | 7.7 ± 5.4 |
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).
| units on a scale | Intervention Group | Wait List Control Group |
|---|---|---|
| Baseline | 18.9 ± 3.8 | 19.1 ± 4.6 |
| 12 Weeks | 20.9 ± 1.8 | 18.9 ± 4.4 |
Total range = 0-100% Higher values represent better outcome Total score is averaged = total%/16 responses
| units on a scale | Intervention Group | Wait List Control Group |
|---|---|---|
| Baseline | 74.9 ± 17.3 | 74.1 ± 12.6 |
| 12 weeks | 72.1 ± 13.3 | 71.2 ± 15.8 |
Collected over One year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Group | 0/15 (0%) | 0/15 (0%) | 1/15 (6.7%) |
| Wait List Control Group | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Event | Intervention Group | Wait List Control Group |
|---|---|---|
| Fall from chair to kneeMusculoskeletal and connective tissue disorders | 1/15 | 0/18 |
| Age, Categorical(Participants) | Intervention Group | Wait List Control Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 15 | 18 | 33 |
| Sex: Female, Male(Participants) | Intervention Group | Wait List Control Group | Total |
|---|---|---|---|
| Female | 8 | 8 | 16 |
| Male | 7 | 10 | 17 |
| Race (NIH/OMB)(Participants) | Intervention Group | Wait List Control Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 15 | 18 | 33 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Intervention Group | Wait List Control Group | Total |
|---|---|---|---|
| United States | 15 | 18 | 33 |
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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