Trial Outcomes & Findings for Telephone-linked Home-based Exercise Training in PD (NCT NCT02898740)

NCT ID: NCT02898740

Last Updated: 2019-11-21

Results Overview

The HAM-D is the most widely used and accepted measure for evaluating depression severity. The HAM-D scores range from a minimum of 0 to a maximum of 50. Higher scores indicate more severe depression. Change = (6 month score) - (baseline score).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: Baseline and 6 months
• Results posted on: 2019-11-21

Participant Flow

Participant milestones

Measure	Exercise Structural exercise: Exercise instruction and encouragement	Health Education Health education: Provision of general information about a variety of health topics
Overall Study STARTED	21	19
Overall Study COMPLETED	21	19
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Exercise n=21 Participants Structural exercise: Exercise instruction and encouragement	Health Education n=19 Participants Health education: Provision of general information about a variety of health topics	Total n=40 Participants Total of all reporting groups
Age, Continuous	70.7 years n=21 Participants	69.3 years n=19 Participants	70.0 years n=40 Participants
Sex: Female, Male Female	0 Participants n=21 Participants	0 Participants n=19 Participants	0 Participants n=40 Participants
Sex: Female, Male Male	21 Participants n=21 Participants	19 Participants n=19 Participants	40 Participants n=40 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Baseline HAM-D score	10.7 years n=21 Participants	9.8 years n=19 Participants	10.3 years n=40 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months

The HAM-D is the most widely used and accepted measure for evaluating depression severity. The HAM-D scores range from a minimum of 0 to a maximum of 50. Higher scores indicate more severe depression. Change = (6 month score) - (baseline score).

Outcome measures

Measure	Exercise n=21 Participants Structural exercise: Exercise instruction and encouragement	Health Education n=19 Participants Health education: Provision of general information about a variety of health topics
Change in Hamilton Rating Scale for Depression (HAM-D) From Baseline to 6 Months	-1.4 units on a scale Interval -12.0 to 7.0	2.0 units on a scale Interval -7.0 to 11.0

Adverse Events

Exercise

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Health Education

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. David Sparrow

VA Boston Healthcare System

Phone: 857-364-6400

Email: david.sparrow@va.gov

Results disclosure agreements

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