Trial Outcomes & Findings for Effect of Exercise in Parkinsonism (NCT NCT02598973)

NCT ID: NCT02598973

Last Updated: 2024-10-15

Results Overview

change in semi-quantitative Ioflupane-I123 uptake comparing exercise to no intervention.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 9 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2024-10-15

Participant Flow

Subjects underwent DAT-SPECT screening was part of the study protocol. Only subjects with positive DAT-SPECT were eligible to be randomized to one of the intervention arms. 9 were positive and started the exercise trial.

Participant milestones

Measure	Exercise aerobic walking	No Exercise normal activity
Overall Study STARTED	5	4
Overall Study COMPLETED	3	3
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Exercise in Parkinsonism

Baseline characteristics by cohort

Measure	Exercise n=5 Participants aerobic walking	No Exercise n=4 Participants normal activity	Total n=9 Participants Total of all reporting groups
Age, Continuous	67.7 years STANDARD_DEVIATION 6.8 • n=5 Participants	61.5 years STANDARD_DEVIATION 10.0 • n=7 Participants	64.2 years STANDARD_DEVIATION 7.9 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	8 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	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 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	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Unified Parkinson's Disease Rating Scale Motor Exam	17.3 units on a scale STANDARD_DEVIATION 2.2 • n=5 Participants	21.0 units on a scale STANDARD_DEVIATION 5.4 • n=7 Participants	19.3 units on a scale STANDARD_DEVIATION 4.8 • n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Although 9 patients were enrolled in the exercise phase of the trial, only 6 (3 exercise arm, 3 control arm) completed the protocol and had a second imaging study to allow analysis of change over time

change in semi-quantitative Ioflupane-I123 uptake comparing exercise to no intervention.

Outcome measures

Measure	Exercise n=3 Participants aerobic walking	No Exercise n=3 Participants normal activity
Change in Dopamine Transporter Imaging	4.6 % change in arbitrary intensity units Standard Deviation 22.0	-15.9 % change in arbitrary intensity units Standard Deviation 9.1

SECONDARY outcome

Timeframe: 8 weeks

Population: although 9 subjects enrolled, only 6 completed the protocol

change in UPRS motor exam at 8 weeks. Minimum 0, Maximum 108. Higher scores indicate more severe disease.

Outcome measures

Measure	Exercise n=3 Participants aerobic walking	No Exercise n=3 Participants normal activity
Change in Overall Motor Function	-2.3 % change in score from baseline Standard Deviation 4.6	10.5 % change in score from baseline Standard Deviation 10.6

Adverse Events

Exercise

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

No Exercise

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Exercise n=5 participants at risk aerobic walking	No Exercise n=4 participants at risk normal activity
Gastrointestinal disorders cancer diagnosis	0.00% 0/5 • AEs were collected from the time of study entry until the end of study participation via weekly calls or spontaneous reporting over an average of 1 year per IRB definitions	25.0% 1/4 • Number of events 1 • AEs were collected from the time of study entry until the end of study participation via weekly calls or spontaneous reporting over an average of 1 year per IRB definitions

Other adverse events

Measure	Exercise n=5 participants at risk aerobic walking	No Exercise n=4 participants at risk normal activity
Cardiac disorders abnormal baseline exercise testing	40.0% 2/5 • Number of events 2 • AEs were collected from the time of study entry until the end of study participation via weekly calls or spontaneous reporting over an average of 1 year per IRB definitions	0.00% 0/4 • AEs were collected from the time of study entry until the end of study participation via weekly calls or spontaneous reporting over an average of 1 year per IRB definitions

Additional Information

James Morley

Crescenz VA Medical Center

Phone: 215-823-5934

Email: james.morley@va.gov

Results disclosure agreements

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