Trial Outcomes & Findings for Effect of Exercise on Gait and Balance in Peripheral Neuropathy (NCT NCT00270842)

NCT ID: NCT00270842

Last Updated: 2015-04-08

Results Overview

The Berg Balance Scale is a commonly used clinical, performance-based measure designed to evaluate performance during various balance activities in community dwelling and institutionalized older adults. The scale consists of 14 common daily balance tasks. Administration requires only minimal basic equipment and takes approximately 15 minutes. All 14 sub-tests are scored on a 5-point ordinal scale based on the subject's ability to perform the requested task safely and in a timely manner. Sub-test scores are summed to achieve a total score ranging from 0 to 56 with higher scores indicating better performance.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 101 participants
• Primary outcome timeframe: 10 weeks
• Results posted on: 2015-04-08

Participant Flow

Participant milestones

Measure	Education Control Group Education group that is the control group for the study. Is a 10 week course with diverse health education topics. Education Control group: This control group participated in 10 weeks of general health education classes.	Functional Balance Training Exercise group that participated in functional balance training Functional Balance: This intervention is a 10 week Functional Balance group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet.	Tai Chi Exercise Group that participated in tai chi training classes Tai Chi: This intervention is a 10 week Tai Chi group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet.
Overall Study STARTED	33	34	34
Overall Study COMPLETED	18	18	18
Overall Study NOT COMPLETED	15	16	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Exercise on Gait and Balance in Peripheral Neuropathy

Baseline characteristics by cohort

Measure	Education Control Group n=31 Participants Education group that is the control group for the study. Is a 10 week course with diverse health education topics. Education Control group: This control group participated in 10 weeks of general health education classes.	Functional Balance Training n=34 Participants Exercise group that participated in functional balance training Functional Balance: This intervention is a 10 week Functional Balance group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet.	Tai Chi n=34 Participants Exercise Group that participated in tai chi training classes Tai Chi: This intervention is a 10 week Tai Chi group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet.	Total n=99 Participants Total of all reporting groups
Age, Continuous	67.5 years STANDARD_DEVIATION 10.2 • n=5 Participants	67.6 years STANDARD_DEVIATION 10.6 • n=7 Participants	68.4 years STANDARD_DEVIATION 9.3 • n=5 Participants	67.8 years STANDARD_DEVIATION 10.6 • n=4 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	15 Participants n=4 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	30 Participants n=7 Participants	29 Participants n=5 Participants	84 Participants n=4 Participants

PRIMARY outcome

Timeframe: 10 weeks

The Berg Balance Scale is a commonly used clinical, performance-based measure designed to evaluate performance during various balance activities in community dwelling and institutionalized older adults. The scale consists of 14 common daily balance tasks. Administration requires only minimal basic equipment and takes approximately 15 minutes. All 14 sub-tests are scored on a 5-point ordinal scale based on the subject's ability to perform the requested task safely and in a timely manner. Sub-test scores are summed to achieve a total score ranging from 0 to 56 with higher scores indicating better performance.

Outcome measures

Measure	Education Control Group n=31 Participants Education group that is the control group for the study. Is a 10 week course with diverse health education topics. Education Control group: This control group participated in 10 weeks of general health education classes.	Functional Balance Training n=34 Participants Exercise group that participated in functional balance training Functional Balance: This intervention is a 10 week Functional Balance group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet.	Tai Chi n=34 Participants Exercise Group that participated in tai chi training classes Tai Chi: This intervention is a 10 week Tai Chi group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet.
Gait and Balance Measures	51.3 units on a scale Standard Deviation 5.4	51.2 units on a scale Standard Deviation 7.0	52.3 units on a scale Standard Deviation 3.3

SECONDARY outcome

Timeframe: 10 weeks

Fall Self Efficacy is operationalized as perceived self efficacy (i.e. self confidence) for avoiding a fall during 10 global, relatively non-hazardous activities of daily living (getting dressed and undressed, for example). Fall self efficacy manifests itself with different degrees of fear of falling, each with a unique associated risk level. The MFES is simple, quick, easy-to-administer scale that assesses a patient's self-reported ability to perform, without falling, each of 14 common activities of daily living in a Likert scale format. Total scale ranges from 0 to 140, the higher score indicated more confidence in ability to manage a fall.

Outcome measures

Measure	Education Control Group n=33 Participants Education group that is the control group for the study. Is a 10 week course with diverse health education topics. Education Control group: This control group participated in 10 weeks of general health education classes.	Functional Balance Training n=34 Participants Exercise group that participated in functional balance training Functional Balance: This intervention is a 10 week Functional Balance group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet.	Tai Chi n=34 Participants Exercise Group that participated in tai chi training classes Tai Chi: This intervention is a 10 week Tai Chi group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet.
Fall Self Efficacy	121.5 units on a scale Standard Deviation 19.9	113.7 units on a scale Standard Deviation 32.3	123.1 units on a scale Standard Deviation 27.3

Adverse Events

Education Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Functional Balance Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Tai Chi

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Patricia A. Quigley

James A. Haley VA

Phone: 8135583912

Email: patricia.quigley@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place