Trial Outcomes & Findings for Community Exercise for Fall Risk in PD (NCT NCT05940077)

NCT ID: NCT05940077

Last Updated: 2023-08-14

Results Overview

Higher scores = worse outcome

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: Baseline and Post-Intervention at approximately 12 weeks
• Results posted on: 2023-08-14

Participant Flow

Participants may be excluded at this point if they demonstrate the presence of definite dementia, determined by Montreal Cognitive Assessment (MoCA < 21).

Participant milestones

Measure	Community-based Exercise Exercise: Community-based exercise involving non-contact boxing and individualized balance training
Overall Study STARTED	20
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Community-based Exercise Exercise: Community-based exercise involving non-contact boxing and individualized balance training
Overall Study the presence of definite dementia, determined by Montreal Cognitive Assessment (MoCA < 21)	1

Baseline Characteristics

Community Exercise for Fall Risk in PD

Baseline characteristics by cohort

Measure	Community-based Exercise n=20 Participants Exercise: Community-based exercise involving non-contact boxing and individualized balance training
Age, Continuous	70.8 years STANDARD_DEVIATION 6.4 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
BMI	27.8 kg/m^2 STANDARD_DEVIATION 4.6 • n=5 Participants
Hoehn & Yahr	2.0 units on a scale STANDARD_DEVIATION 0.7 • n=5 Participants
UPDRS (motor)	16.9 units on a scale STANDARD_DEVIATION 4.9 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Post-Intervention at approximately 12 weeks

Higher scores = worse outcome

Outcome measures

Measure	Baseline n=20 Participants Community-based exercise involving non-contact boxing and individualized balance training	Post Intervention n=20 Participants Community-based exercise involving non-contact boxing and individualized balance training
Number of Falls Experienced During the Study Period as Reported by Self-report	16 self-reported falls Standard Error 1.89	7 self-reported falls Standard Error 0.83

SECONDARY outcome

Timeframe: Baseline and Post-Intervention at approximately 12 weeks

The "timed up and go test" (TUG) is a simple test of the subjects' ability to understand an instruction and perform the task of standing, walking 10ft, turning around, returning 10ft and sitting down Timed Up and Go, higher scores = worse outcome

Outcome measures

Measure	Baseline n=20 Participants Community-based exercise involving non-contact boxing and individualized balance training	Post Intervention n=20 Participants Community-based exercise involving non-contact boxing and individualized balance training
TUG	11.02 seconds Standard Deviation 3.28	8.13 seconds Standard Deviation 1.74

SECONDARY outcome

Timeframe: Baseline and Post-Intervention at approximately 12 weeks

The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function.

Scale = 0 - 56 (higher scores = better function)

Outcome measures

Measure	Baseline n=20 Participants Community-based exercise involving non-contact boxing and individualized balance training	Post Intervention n=20 Participants Community-based exercise involving non-contact boxing and individualized balance training
BBS	40.47 score on a scale Standard Deviation 9.51	46.84 score on a scale Standard Deviation 6.73

SECONDARY outcome

Timeframe: Baseline and Post-Intervention at approximately 12 weeks

The Activities-Specific Balance Confidence (ABC) scale is a self-report measure of balance confidence in performing various activities without losing balance or experiencing a sense of unsteadiness. The ABC Scale has 16 questions that require the patient to rate his/her confidence that he/she will not lose balance or become unsteady while performing various activities.

Scale: 0 - 100 (higher scores = better confidence)

Outcome measures

Measure	Baseline n=20 Participants Community-based exercise involving non-contact boxing and individualized balance training	Post Intervention n=20 Participants Community-based exercise involving non-contact boxing and individualized balance training
ABC	78.92 score on a scale Standard Deviation 8.74	86.05 score on a scale Standard Deviation 9.45

SECONDARY outcome

Timeframe: Baseline and Post-Intervention at approximately 12 weeks

The Five Times Sit-to-Stand Test (5-STS) is used to asses functional lower extremity strength, transitional movements, balance, and fall risk in older adults. Scoring is based on the amount of time (to the nearest decimal in seconds) a patient is able to transfer from a seated to a standing position and back to sitting five times.

Higher scores = Worse outcome

Outcome measures

Measure	Baseline n=20 Participants Community-based exercise involving non-contact boxing and individualized balance training	Post Intervention n=20 Participants Community-based exercise involving non-contact boxing and individualized balance training
5-STS	15.58 seconds Standard Deviation 3.39	11.53 seconds Standard Deviation 3.08

Adverse Events

Community-based Exercise

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. Evan Papa

Tufts University

Phone: 617-636-4056

Email: evan.papa@tufts.edu

Results disclosure agreements

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