Heart FailureBASICNCT02566785
Balance Training for Elders With Heart Failure
A study testing Balance Intervention in people with Heart Failure, run by University of Nebraska at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Balance Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2016to 16 Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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].
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center, College of Nursing
Lincoln, Nebraska, 68588-0220
About this study
Official title: Balance Activities and Strengthening to Improve Condition [BASIC]: Training for Elders With Heart Failure
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Balance Intervention
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Other: Balance Intervention |
| Wait List Control Group | Other | 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. Receives: Other: Balance Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Baseline and 12 weeks
Secondary outcomes (1)
Activity Balance Confidence Scale
Total range = 0-100% Higher values represent better outcome Total score is averaged = total%/16 responses
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study start1 Feb 2016
- Primary completion16 Dec 2016
- Study completion16 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- American Nurses Foundation
- Responsible party
- Sponsor
- Investigators
- Rita L McGuire, PhD, RN, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02566785
- Sponsor's protocol ID
- 0677-15-FB
- Acronym
- BASIC
- Status last verified
- Sep 2023
- First submitted
- 28 Sep 2015
- Last updated
- 25 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balance Activities and Strengthening to Improve Condition [BASIC]: Training for Elders With Heart Failure
- ClinicalTrials.gov ID
- NCT02566785
- Acronym / sponsor ID
- BASIC / 0677-15-FB
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- American Nurses Foundation
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 16 Dec 2016 (actual)
- Study completion
- 16 Dec 2016 (actual)
- First posted
- 2 Oct 2015 (estimated)
- Results
- Posted 9 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Balance InterventionThose 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. |
| Wait List Control Group | Other | Other: Balance InterventionThe 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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].
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balance InterventionThe 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. | Other | Intervention Group, Wait List Control Group |
Primary outcome
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
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).
1 secondary outcome
Activity Balance Confidence Scale
Time frame: Baseline and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rita L McGuire, PhD, RN principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance Intervention in people with Heart Failure, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2023.