Trial Outcomes & Findings for Balance Training for Elders With Heart Failure (NCT NCT02566785)
NCT ID: NCT02566785
Last Updated: 2023-09-25
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
33 participants
Primary outcome timeframe
Baseline and 12 weeks
Results posted on
2023-09-25
Participant Flow
November 2015 through June 2016 at the Heart Failure Improvement Program of a regional hospital.
Participant milestones
| Measure |
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.
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.
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 Study
STARTED
|
15
|
18
|
|
Overall Study
COMPLETED
|
14
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
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.
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.
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 Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Worsening condition
|
1
|
1
|
Baseline Characteristics
Balance Training for Elders With Heart Failure
Baseline characteristics by cohort
| Measure |
Intervention Group
n=15 Participants
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.
|
Wait List Control Group
n=18 Participants
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
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksPopulation: Two of the participants in the WLC group were there for testing at 12 weeks.
Outcome measures
| Measure |
Intervention Group
n=14 Participants
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.
|
Wait List Control Group
n=13 Participants
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.
|
|---|---|---|
|
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.
12 Weeks
|
7.9 number of sit to stand cycles
Standard Deviation 4.5
|
7.7 number of sit to stand cycles
Standard Deviation 5.4
|
|
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.
Baseline
|
6.9 number of sit to stand cycles
Standard Deviation 4.2
|
6.5 number of sit to stand cycles
Standard Deviation 3.6
|
PRIMARY outcome
Timeframe: Baseline and 12 weeks8 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).
Outcome measures
| Measure |
Intervention Group
n=14 Participants
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.
|
Wait List Control Group
n=15 Participants
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.
|
|---|---|---|
|
Dynamic Gait Index
Baseline
|
18.9 units on a scale
Standard Deviation 3.8
|
19.1 units on a scale
Standard Deviation 4.6
|
|
Dynamic Gait Index
12 Weeks
|
20.9 units on a scale
Standard Deviation 1.8
|
18.9 units on a scale
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksTotal range = 0-100% Higher values represent better outcome Total score is averaged = total%/16 responses
Outcome measures
| Measure |
Intervention Group
n=14 Participants
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.
|
Wait List Control Group
n=15 Participants
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.
|
|---|---|---|
|
Activity Balance Confidence Scale
12 weeks
|
72.1 units on a scale
Standard Deviation 13.3
|
71.2 units on a scale
Standard Deviation 15.8
|
|
Activity Balance Confidence Scale
Baseline
|
74.9 units on a scale
Standard Deviation 17.3
|
74.1 units on a scale
Standard Deviation 12.6
|
Adverse Events
Intervention Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Wait List Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intervention Group
n=15 participants at risk
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.
|
Wait List Control Group
n=18 participants at risk
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.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Fall from chair to knee
|
6.7%
1/15 • Number of events 1 • One year
|
0.00%
0/18 • One year
|
Additional Information
Dr. Rita McGuire
University of Nebraska Medical Center College of Nursing
Phone: 402-472-4712
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place