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Balance Training for Elders With Heart Failure (BASIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Collaborator:
American Nurses Foundation
Information provided by (Responsible Party):
Rita L. McGuire, PhD, RN, University of Nebraska

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Heart Failure
Intervention Other: Balance Intervention
Enrollment 33
Recruitment Details November 2015 through June 2016 at the Heart Failure Improvement Program of a regional hospital.
Pre-assignment Details  
Arm/Group Title Intervention Group Wait List Control Group
Hide Arm/Group Description

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.

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.

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.

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.

Period Title: Overall Study
Started 15 18
Completed 14 15
Not Completed 1 3
Reason Not Completed
Lost to Follow-up             0             2
Worsening condition             1             1
Arm/Group Title Intervention Group Wait List Control Group Total
Hide Arm/Group Description

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.

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.

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 15 18 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 18 participants 33 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
15
 100.0%
18
 100.0%
33
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 18 participants 33 participants
Female
8
  53.3%
8
  44.4%
16
  48.5%
Male
7
  46.7%
10
  55.6%
17
  51.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 18 participants 33 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
15
 100.0%
18
 100.0%
33
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 15 participants 18 participants 33 participants
15
 100.0%
18
 100.0%
33
 100.0%
1.Primary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Two of the participants in the WLC group were there for testing at 12 weeks.
Arm/Group Title Intervention Group Wait List Control Group
Hide Arm/Group Description:

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.

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.

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.

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.

Overall Number of Participants Analyzed 14 13
Mean (Standard Deviation)
Unit of Measure: number of sit to stand cycles
Baseline 6.9  (4.2) 6.5  (3.6)
12 Weeks 7.9  (4.5) 7.7  (5.4)
2.Primary Outcome
Title Dynamic Gait Index
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Group Wait List Control Group
Hide Arm/Group Description:

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.

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.

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.

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.

Overall Number of Participants Analyzed 14 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 18.9  (3.8) 19.1  (4.6)
12 Weeks 20.9  (1.8) 18.9  (4.4)
3.Secondary Outcome
Title Activity Balance Confidence Scale
Hide Description Total range = 0-100% Higher values represent better outcome Total score is averaged = total%/16 responses
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Group Wait List Control Group
Hide Arm/Group Description:

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.

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.

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.

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.

Overall Number of Participants Analyzed 14 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 74.9  (17.3) 74.1  (12.6)
12 weeks 72.1  (13.3) 71.2  (15.8)
Time Frame One year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intervention Group Wait List Control Group
Hide Arm/Group Description

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.

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.

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.

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.

All-Cause Mortality
Intervention Group Wait List Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)      0/18 (0.00%)    
Hide Serious Adverse Events
Intervention Group Wait List Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      0/18 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intervention Group Wait List Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/15 (6.67%)      0/18 (0.00%)    
Musculoskeletal and connective tissue disorders     
Fall from chair to knee * [1]  1/15 (6.67%)  1 0/18 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Fell from seated on chair to knees when attempting to stand during testing. Lowered gently to floor by balance team member who had a gait belt on participant.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Rita McGuire
Organization: University of Nebraska Medical Center College of Nursing
Phone: 402-472-4712
EMail: rita.mcguire@unmc.edu
Layout table for additonal information
Responsible Party: Rita L. McGuire, PhD, RN, University of Nebraska
ClinicalTrials.gov Identifier: NCT02566785    
Other Study ID Numbers: 677-15-FB
First Submitted: September 28, 2015
First Posted: October 2, 2015
Results First Submitted: July 11, 2017
Results First Posted: October 9, 2018
Last Update Posted: October 9, 2018