Trial Outcomes & Findings for Effectiveness and Implementation of the HiBalance Program in Clinical Practice (NCT NCT02727478)

Results Overview

Mini-Balance Evaluation Systems Test a rating scale for dynamic balance incorporating 14 different balance and gait items that were assessed by a physical therapist on a scale from 0-2. Maximum points 28. 0-28 points with higher scores indicating better balance control The mini-BESTest is an assessment of balance performance and will be performed by the physiotherapists in the respective clinics.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

117 participants

Primary outcome timeframe

Change in Mini-BESTest score from baseline at 1 week post intervention.

Results posted on

2023-08-14

Participant Flow

Participant milestones

Participant milestones
Measure	Balance Training Group 1 hour group balance training twice weekly for 10 weeks, as well as perform a home exercise program. HiBalance training program: The program consists of physiotherapist led highly challenging balance exercises, which are adapted and progressed on both a group and individual basis throughout the training period.	Control Group Subjects in this group will receive no intervention and will be advised to continue their normal level of exercise throughout the intervention period.
Overall Study STARTED	61	56
Overall Study COMPLETED	53	46
Overall Study NOT COMPLETED	8	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Balance Training Group 1 hour group balance training twice weekly for 10 weeks, as well as perform a home exercise program. HiBalance training program: The program consists of physiotherapist led highly challenging balance exercises, which are adapted and progressed on both a group and individual basis throughout the training period.	Control Group Subjects in this group will receive no intervention and will be advised to continue their normal level of exercise throughout the intervention period.
Overall Study Withdrawal by Subject	8	10

Baseline Characteristics

Effectiveness and Implementation of the HiBalance Program in Clinical Practice

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Balance Training Group n=61 Participants 1 hour group balance training twice weekly for 10 weeks, as well as perform a home exercise program. HiBalance training program: The program consists of physiotherapist led highly challenging balance exercises, which are adapted and progressed on both a group and individual basis throughout the training period.	Control Group n=56 Participants Subjects in this group will receive no intervention and will be advised to continue their normal level of exercise throughout the intervention period.	Total n=117 Participants Total of all reporting groups
Age, Continuous	70 years STANDARD_DEVIATION 8.5 • n=5 Participants	70 years STANDARD_DEVIATION 6.5 • n=7 Participants	70. years STANDARD_DEVIATION 7.6 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	22 Participants n=7 Participants	55 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	34 Participants n=7 Participants	62 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	61 Participants n=5 Participants	56 Participants n=7 Participants	117 Participants n=5 Participants

PRIMARY outcome

Timeframe: Change in Mini-BESTest score from baseline at 1 week post intervention.

Mini-Balance Evaluation Systems Test a rating scale for dynamic balance incorporating 14 different balance and gait items that were assessed by a physical therapist on a scale from 0-2. Maximum points 28. 0-28 points with higher scores indicating better balance control The mini-BESTest is an assessment of balance performance and will be performed by the physiotherapists in the respective clinics.

Outcome measures

Outcome measures
Measure	Balance Training Group n=61 Participants 1 hour group balance training twice weekly for 10 weeks, as well as perform a home exercise program. HiBalance training program: The program consists of physiotherapist led highly challenging balance exercises, which are adapted and progressed on both a group and individual basis throughout the training period.	Control Group n=56 Participants Subjects in this group will receive no intervention and will be advised to continue their normal level of exercise throughout the intervention period.
Change in Mini-BESTest Score From Baseline at 1 Week Post Intervention.	2.0 score on a scale Standard Deviation 2.0	-0.2 score on a scale Standard Deviation 2.4

SECONDARY outcome

Timeframe: From baseline at 1 week post intervention.

The 10-meter walking test assesses gait performance was performed by the physiotherapists in the respective clinics. Gait speed was measured as m/sec during 10 meters

Outcome measures

Outcome measures
Measure	Balance Training Group n=60 Participants 1 hour group balance training twice weekly for 10 weeks, as well as perform a home exercise program. HiBalance training program: The program consists of physiotherapist led highly challenging balance exercises, which are adapted and progressed on both a group and individual basis throughout the training period.	Control Group n=56 Participants Subjects in this group will receive no intervention and will be advised to continue their normal level of exercise throughout the intervention period.
Change in 10-meter Walking Test Score From Baseline at 1 Week Post Intervention.	0.2 m/sec Standard Deviation 0.41	-0.04 m/sec Standard Deviation 0.14

SECONDARY outcome

Timeframe: From baseline at 1 week post intervention.

The TUG test assesses functional mobility and will be performed by the physiotherapists in the respective clinics. TUG test measures performance of a sequential locomotor task (rising from a chair, walking 3 m, turning and walking back to the chair). Timed Up and Go (TUG) test is measured in seconds it takes to perform the task.

Outcome measures

Outcome measures
Measure	Balance Training Group n=61 Participants 1 hour group balance training twice weekly for 10 weeks, as well as perform a home exercise program. HiBalance training program: The program consists of physiotherapist led highly challenging balance exercises, which are adapted and progressed on both a group and individual basis throughout the training period.	Control Group n=56 Participants Subjects in this group will receive no intervention and will be advised to continue their normal level of exercise throughout the intervention period.
Change in Timed Up and Go (TUG) Test From Baseline at 1 Week Post Intervention.	-0.4 seconds Interval -1.13 to 0.5	0 seconds Interval -1.6 to 1.2

SECONDARY outcome

Timeframe: From baseline at 1week post intervention.

The EQ-5D is a 2-paged form assessing health-related quality of life and will be filled in by participants. European Quality of Life- 5 dimensions (EQ-5D), The visual analogue scale (VAS) indicates the general health status ranging from 0-100 with 100 indicating the best health status

Outcome measures

Outcome measures
Measure	Balance Training Group n=59 Participants 1 hour group balance training twice weekly for 10 weeks, as well as perform a home exercise program. HiBalance training program: The program consists of physiotherapist led highly challenging balance exercises, which are adapted and progressed on both a group and individual basis throughout the training period.	Control Group n=48 Participants Subjects in this group will receive no intervention and will be advised to continue their normal level of exercise throughout the intervention period.
Change in EQ-5D Score From Baseline at 1week Post Intervention.	5.5 units on a scale Interval -5.0 to 15.0	0 units on a scale Interval -10.0 to 5.0

SECONDARY outcome

Timeframe: From baseline at 1 week post intervention.

The ABC scale assesses self-reported balance confidence and will be filled in by study participants. It consists of 16 items that are rated from from 0-100% where 0% indicates no confidence and 100% complete confidence. The overall score is calculated by adding the item scores and dividing the total by 16 (i.e. the number of items). This total score ranges from 0% to 100%.

Outcome measures

Outcome measures
Measure	Balance Training Group n=60 Participants 1 hour group balance training twice weekly for 10 weeks, as well as perform a home exercise program. HiBalance training program: The program consists of physiotherapist led highly challenging balance exercises, which are adapted and progressed on both a group and individual basis throughout the training period.	Control Group n=47 Participants Subjects in this group will receive no intervention and will be advised to continue their normal level of exercise throughout the intervention period.
Change in Activities-specific Balance Confidence (ABC) Scale	68 units on a scale Standard Deviation 16.9	70 units on a scale Standard Deviation 18.2

SECONDARY outcome

Timeframe: from baseline to 1 week post intervention

Participants will wear accelerometers for a 7-day period directly before and after the intervention. Physical activity level (steps per day)

Outcome measures

Outcome measures
Measure	Balance Training Group n=53 Participants 1 hour group balance training twice weekly for 10 weeks, as well as perform a home exercise program. HiBalance training program: The program consists of physiotherapist led highly challenging balance exercises, which are adapted and progressed on both a group and individual basis throughout the training period.	Control Group n=48 Participants Subjects in this group will receive no intervention and will be advised to continue their normal level of exercise throughout the intervention period.
Change in Physical Activity Level From Baseline 1 Week Post Intervention.	-288 steps per day Standard Deviation 1428	-390 steps per day Standard Deviation 2016

SECONDARY outcome

Timeframe: From baseline at 1 week post intervention.

The TUG test assesses functional mobility and will be performed by the physiotherapists in the respective clinics. TUG test measures performance of a sequential locomotor task (rising from a chair, walking 3 m, turning and walking back to the chair).The TUG COG test involves performance of the TUG test while sequentially subtracting the number 3 from a start number. The time difference between the TUG and the TUG COG reflects dual-task interference during functional mobility and is calculated be expressed as a percentage: (TUG COG - TUG)/TUG.

Outcome measures

Outcome measures
Measure	Balance Training Group n=53 Participants 1 hour group balance training twice weekly for 10 weeks, as well as perform a home exercise program. HiBalance training program: The program consists of physiotherapist led highly challenging balance exercises, which are adapted and progressed on both a group and individual basis throughout the training period.	Control Group n=55 Participants Subjects in this group will receive no intervention and will be advised to continue their normal level of exercise throughout the intervention period.
Change in Dual Task Interference During the Timed Up and Go (TUG) Test From Baseline at 1 Week Post Intervention.	-1.22 percentage of interference Interval -6.2 to 0.66	1.05 percentage of interference Interval -3.07 to 3.51

Adverse Events

Balance Training Group

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

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

Other adverse events
Measure	Balance Training Group n=61 participants at risk 1 hour group balance training twice weekly for 10 weeks, as well as perform a home exercise program. HiBalance training program: The program consists of physiotherapist led highly challenging balance exercises, which are adapted and progressed on both a group and individual basis throughout the training period.	Control Group Subjects in this group will receive no intervention and will be advised to continue their normal level of exercise throughout the intervention period.
Injury, poisoning and procedural complications Falls	19.7% 12/61 • Number of events 12 • 10 weeks Adverse events collected through observation during the training sessions. All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the Control Group.	— 0/0 • 10 weeks Adverse events collected through observation during the training sessions. All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the Control Group.

Additional Information

Dr Breiffni Leavy

Karolinska Instituet

Phone: +46852488814

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place