Trial Outcomes & Findings for Improving Balance and Mobility (NCT NCT02374463)

Last Updated: 2020-03-27

Results Overview

the Four Square Step Test assesses dynamic balance and coordination through stepping forwards, sideways, and backwards in a timed fashion. The four square step test is timed in seconds. Higher scores are associated with worse outcome. Individuals with higher scores are at increased risk of falling with some using a score of 15 seconds or higher as being at high risk for falls. The minimum value one would see in young healthy populations for this test is 5 seconds. The maximum value is 60 seconds. If they are deemed unable to complete the value is not reported

Recruitment status

COMPLETED

Study phase

Target enrollment

41 participants

Primary outcome timeframe

The FSST was assessed at 6 month (post) and at baseline (pre)

Results posted on

2020-03-27

Participant Flow

Older community dwelling veterans (age \> 65 years) with evidence of balance dysfunction (Four Square Step Test \> 8 seconds) and or history of falling were recruited for this study. 41 subjects signed informed consent. 10 subjects were ineligible, 4 dropped out prior to completing baseline testing resulting in 27 subjects who were randomized.

Participant milestones

Participant milestones
Measure	MMBI Multimodality Balance Intervention (MMBI): The Investigator's MMBI class will be held 3-times a week for an hour and will consist of a group dynamic balance class (30 minutes), a supervised obstacle course (10 minutes), and lower extremity and core strengthening (20 minutes). The group exercise classes will focus on dynamic weight shifts with an emphasis on the lateral and diagonal directions. Over the 6 months of class, the exercises will gradually increase in difficulty to challenge balance. A skilled instructor will lead each class and 1-2 assistants will be present to assist with fall risk prevention. The supervised obstacle course will focus on obstacle negotiation, gait over challenging surfaces, and moving in lateral, diagonal, and backward directions. Finally, strength training of the lower extremities and core will focus on strengthening major muscles of the lower extremity and core utilizing commonly available gym equipment, ankle weights and body weight.	Tai Chi Tai Chi Intervention: The supervised Tai Chi class will be held 3-times a week for one hour. All Tai Chi classes will be taught in a group setting by an experienced instructor. The emphasis during the class will be on standing movements, body alignment, weight shift and changes of direction. Movements will be adapted as the class progresses to increase the difficulty of weight shift and change in direction over time so that participants balance is continually challenged throughout the 6 months. Chairs or hand rails will be available for the participants to use as needed for balance recovery.
Overall Study STARTED	15	12
Overall Study COMPLETED	12	9
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	MMBI Multimodality Balance Intervention (MMBI): The Investigator's MMBI class will be held 3-times a week for an hour and will consist of a group dynamic balance class (30 minutes), a supervised obstacle course (10 minutes), and lower extremity and core strengthening (20 minutes). The group exercise classes will focus on dynamic weight shifts with an emphasis on the lateral and diagonal directions. Over the 6 months of class, the exercises will gradually increase in difficulty to challenge balance. A skilled instructor will lead each class and 1-2 assistants will be present to assist with fall risk prevention. The supervised obstacle course will focus on obstacle negotiation, gait over challenging surfaces, and moving in lateral, diagonal, and backward directions. Finally, strength training of the lower extremities and core will focus on strengthening major muscles of the lower extremity and core utilizing commonly available gym equipment, ankle weights and body weight.	Tai Chi Tai Chi Intervention: The supervised Tai Chi class will be held 3-times a week for one hour. All Tai Chi classes will be taught in a group setting by an experienced instructor. The emphasis during the class will be on standing movements, body alignment, weight shift and changes of direction. Movements will be adapted as the class progresses to increase the difficulty of weight shift and change in direction over time so that participants balance is continually challenged throughout the 6 months. Chairs or hand rails will be available for the participants to use as needed for balance recovery.
Overall Study Withdrawal by Subject	3	3

Baseline Characteristics

Improving Balance and Mobility

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MMBI n=15 Participants Multimodality Balance Intervention (MMBI)	Tai Chi n=12 Participants Tai Chi Intervention	Total n=27 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	15 Participants n=5 Participants	12 Participants n=7 Participants	27 Participants n=5 Participants
Age, Continuous	74.6 years STANDARD_DEVIATION 8.2 • n=5 Participants	75.7 years STANDARD_DEVIATION 5.1 • n=7 Participants	75.1 years STANDARD_DEVIATION 4.3 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	12 Participants n=7 Participants	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	1 Participants n=5 Participants	0 Participants n=7 Participants	1 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	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	9 Participants n=7 Participants	21 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	15 Participants n=5 Participants	12 Participants n=7 Participants	27 Participants n=5 Participants
four square step test	11.6 seconds STANDARD_DEVIATION 2.0 • n=5 Participants	12.3 seconds STANDARD_DEVIATION 3.4 • n=7 Participants	12 seconds STANDARD_DEVIATION 3 • n=5 Participants
% body fat	37.7 % body fat STANDARD_DEVIATION 8.9 • n=5 Participants	38.8 % body fat STANDARD_DEVIATION 5.0 • n=7 Participants	38.2 % body fat STANDARD_DEVIATION 4.1 • n=5 Participants
isometric strength hip	46.2 newton squared STANDARD_DEVIATION 17.2 • n=5 Participants	48.5 newton squared STANDARD_DEVIATION 28.1 • n=7 Participants	47.1 newton squared STANDARD_DEVIATION 22.3 • n=5 Participants
isometric strength knee	114.6 newton squared STANDARD_DEVIATION 49.8 • n=5 Participants	127.4 newton squared STANDARD_DEVIATION 31.1 • n=7 Participants	120.2 newton squared STANDARD_DEVIATION 27.2 • n=5 Participants

PRIMARY outcome

Timeframe: The FSST was assessed at 6 month (post) and at baseline (pre)

Population: the change in four square step test score is calculated as the 6 month (post) - the baseline value (pre)

Outcome measures

Outcome measures
Measure	MMBI n=12 Participants Multimodality Balance Intervention (MMBI)	Tai Chi n=9 Participants Tai Chi Intervention
Balance and Lateral Mobility Assessed by the Four Square Step Test	-1.8 seconds Standard Deviation 0.9	-0.6 seconds Standard Deviation 0.3

SECONDARY outcome

Timeframe: FGA ws measured at 6 months (post) and at baseline (pre)

Population: The change in FGA was calculated as the value at 6 months (post)- the value at baseline (pre)

The Functional Gait Assessment (FGA) is designed to assess postural stability during gait. The measure is calculated by summing the scores for 10 gait related tasks. Each task is scored from 3 to 0, where 3 is the best possible performance (normal) and 0 indicates severe impairment related to the task. The best possible score is 30 and the worst possible score is 0. Higher values are associated with better outcome. A value of 22/30 and below is associated with high risk of falling in the community.

Outcome measures

Outcome measures
Measure	MMBI n=12 Participants Multimodality Balance Intervention (MMBI)	Tai Chi n=9 Participants Tai Chi Intervention
Functional Gait Analysis	7.28 score on a scale Standard Deviation 3.64	-0.5 score on a scale Standard Deviation 0.3

SECONDARY outcome

Timeframe: Strength at the R knee was assessed at 6 months (post) and at baseline (pre)

Change in isometric strength R knee assessed using the biodex measured before and after intervention. Change was calculated as value at 6 months (post)-value at baseline (pre).Higher values are a better outcome

Outcome measures

Outcome measures
Measure	MMBI n=12 Participants Multimodality Balance Intervention (MMBI)	Tai Chi n=9 Participants Tai Chi Intervention
Change in Strength R Knee Biodex	21.8 newton squared Standard Deviation 10.5	-16.2 newton squared Standard Deviation 8.1

SECONDARY outcome

Timeframe: 6 months

This is the number of subjects who self-reported at least one fall, and does not include trips or near falls. This measure does not include the total number of falls as there were several participants who reported more than one fall.

Outcome measures

Outcome measures
Measure	MMBI n=15 Participants Multimodality Balance Intervention (MMBI)	Tai Chi n=12 Participants Tai Chi Intervention
Number of Subjects Who Reported Falls	3 participants	3 participants

SECONDARY outcome

Timeframe: Strength in the R hip was assessed at 6 months (post) and at baseline (pre)

Population: Change calculated as 6 month value (post)- baseline value (pre)

Assessment of change in strength using biodex. Higher values are associated with better outcome

Outcome measures

Outcome measures
Measure	MMBI n=12 Participants Multimodality Balance Intervention (MMBI)	Tai Chi n=9 Participants Tai Chi Intervention
Change in Strength R Hip Using Biodex	10.4 newton squared Standard Deviation 5.2	-10.1 newton squared Standard Deviation 5.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

change in total body fat measured using Dual-energy X-ray absorptiometry (DXA). Value was calculated as value at 6 months (post) - value at baseline (pre)

Outcome measures

Outcome measures
Measure	MMBI n=12 Participants Multimodality Balance Intervention (MMBI)	Tai Chi n=9 Participants Tai Chi Intervention
Percent Body Fat	-0.37 percentage of body fat Standard Deviation 0.19	-0.1 percentage of body fat Standard Deviation 0.05

Adverse Events

MMBI

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Tai Chi

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MMBI n=15 participants at risk Multimodality Balance Intervention (MMBI)	Tai Chi n=12 participants at risk Tai Chi Intervention
Gastrointestinal disorders hospitalization	6.7% 1/15 • Number of events 1 • 6 months Prospective monitoring	8.3% 1/12 • Number of events 1 • 6 months Prospective monitoring

Other adverse events

Other adverse events
Measure	MMBI n=15 participants at risk Multimodality Balance Intervention (MMBI)	Tai Chi n=12 participants at risk Tai Chi Intervention
Musculoskeletal and connective tissue disorders fall	20.0% 3/15 • Number of events 15 • 6 months Prospective monitoring	25.0% 3/12 • Number of events 12 • 6 months Prospective monitoring

Additional Information

Leslie Katzel, MD, PhD

Baltimore VA Medical Center

Phone: 410-605-7248

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place