Community Exercise for Fall Risk in PD

Influence of Community-based Group Exercise on Fall Risk in Parkinson's Disease

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05940077

Enrollment

Registered

2023-07-11

Start date

2020-07-15

Completion date

2022-03-30

Last updated

2023-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exercise, Fall, Parkinson Disease

Brief summary

Parkinson's disease (PD) affects approximately 1 million people in the United States and causes significant fall risks. This study aims to develop a community-based exercise program that reduces falls in persons with PD. By combining individualized balance activities with group boxing training, the study seeks to identify modifiable risk factors, improve balance dysfunction, and reduce falls. The findings will inform clinical practice, offering a community-based exercise model to address the urgent need for effective fall prevention interventions in PD.

Detailed description

Parkinson's disease (PD) is the second most common neurodegenerative disorder and effects approximately 1 million people in the United States. Falls are a significant problem for persons with PD, with incidence rates ranging from 37-80% each year. The long-term goal of this research is to develop exercise training programs to reduce falls in persons with PD. Physical activity and exercise are commonly understood to provide significant benefits in functional mobility for persons with PD. Unfortunately, the translation of improved mobility to an actual reduction in falls has been recalcitrant to traditional exercise therapies. The following proposal is aimed at identifying the modifiable risk factors for falls in persons with PD and characterizing the effect of a novel exercise intervention on fall risk. The investigators will conduct a 12 week community-based exercise program in 20 individuals in which two validated forms of exercise training will be combined into one program. Specifically, individualized balance activities tailored to different domains of balance dysfunction for each individual will be combined with non-contact group boxing training to maximize the therapeutic benefit. The research aims of this investigation are 1) identify the individual characteristics of responders to exercise such as modifiable factors like lower-extremity kinematic joint range of motion and balance domain dysfunction at baseline, and 2) determine if a novel community-based exercise regimen that combines accepted balance and strength training protocols can synergistically improve balance dysfunction and reduce falls. The benefits of exercise in general on PD are undisputed, but there remains an urgent, unmet need for the identification of exercise interventions that can reduce falls. The proposed research is significant because it is expected to provide evidence that a novel community-based exercise program is capable of improving functional mobility in such a way that it can reduce fall incidence for persons with PD. The research aims in this proposal are expected to directly inform clinical practice for rehabilitation providers by identifying the modifiable risk factors that lead to falls in PD and delivering a community-based exercise model that can reduce the harmful effects of falls in this population.

Interventions

BEHAVIORALExercise

Community-based exercise involving non-contact boxing and individualized balance training

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

Healthy volunteers

Inclusion criteria

* A diagnosis of idiopathic PD; Male or female 30 years or older at time of PD diagnosis; Hoehn & Yahr (H&Y) stages 1.0-3.0; Ability to provide informed consent in accordance with Good Clinical Practice (GCP) and local regulations.

Exclusion criteria

* Idiopathic PD H&Y stage 4-5, in order to constrain motor dysfunctions to mild-to-moderate PD; Confirmed or suspected atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis, or degenerative diseases; Presence of definite dementia by Montreal Cognitive Assessment (MoCA \<21); Central or peripheral nervous system disorders (other than PD); Myopathic disease (e.g. focal myopathy) that affects skeletal muscle structure/function; Severe cardiovascular disease that limits exercise abilities.

Design outcomes

Primary

Measure	Time frame	Description
Number of Falls Experienced During the Study Period as Reported by Self-report	Baseline and Post-Intervention at approximately 12 weeks	Higher scores = worse outcome

Secondary

Measure	Time frame	Description
TUG	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
BBS	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)
ABC	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)
5-STS	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

Countries

United States

Participant flow

Pre-assignment details

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

Participants by arm

Arm	Count
Community-based Exercise Exercise: Community-based exercise involving non-contact boxing and individualized balance training	20
Total	20

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	the presence of definite dementia, determined by Montreal Cognitive Assessment (MoCA < 21)	1

Baseline characteristics

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

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 20
other Total, other adverse events	0 / 20
serious Total, serious adverse events	0 / 20