Trial Outcomes & Findings for Study in Parkinson's Disease of Exercise (NCT NCT01506479)

Last Updated: 2017-10-13

Results Overview

To test whether individuals with de novo Parkinson's disease (naïve to drug treatment) can achieve the randomly assigned levels of mean exercise intensity (60-65% average HRmax or 80-85% average HRmax) and adhere to the exercise protocol.

Recruitment status

COMPLETED

Study phase

Target enrollment

128 participants

Primary outcome timeframe

9 to 26 weeks

Results posted on

2017-10-13

Participant Flow

Prescreening by telephone and for patients in movement disorder clinics from May 2012 to November 2015.

Screening included confirmation of Parkinson disease diagnosis, assessment of depression and cognition, testing for laboratory measures, and testing for blood pressure and echocardiogram responses to exercise during graded exercise. Once deemed eligible, baseline assessments were completed for disease and non-disease specific scales.

Participant milestones

Participant milestones
Measure	Control Group Wait listed to moderate or vigorous exercise after 6 months of no exercise. No Intervention: No-exercise control (i.e., usual care);	Vigorous Exercise Endurance exercise at 80-85% HR max, 4x/wk for 6 months. Vigorous Exercise: Endurance exercise at 80-85% HR max, 4x/wk for 6 months.	Moderate Exercise Endurance exercise at 60-65% HR max, 4x/wk for 6 months. Moderate Exercise: Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months.
Overall Study STARTED	40	43	45
Overall Study COMPLETED	37	38	42
Overall Study NOT COMPLETED	3	5	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Control Group Wait listed to moderate or vigorous exercise after 6 months of no exercise. No Intervention: No-exercise control (i.e., usual care);	Vigorous Exercise Endurance exercise at 80-85% HR max, 4x/wk for 6 months. Vigorous Exercise: Endurance exercise at 80-85% HR max, 4x/wk for 6 months.	Moderate Exercise Endurance exercise at 60-65% HR max, 4x/wk for 6 months. Moderate Exercise: Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months.
Overall Study Lost to Follow-up	1	2	2
Overall Study Withdrawal by Subject	1	2	1
Overall Study Missing assessment	1	0	0
Overall Study Adverse Event	0	1	0

Baseline Characteristics

Several participants did not wear the activity monitor devices for recording total number of daily steps.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Group n=40 Participants Wait listed to moderate or vigorous exercise after 6 months of no exercise. No Intervention: No-exercise control (i.e., usual care);	Vigorous Exercise n=43 Participants Endurance exercise at 80-85% HR max, 4x/wk for 6 months. Vigorous Exercise: Endurance exercise at 80-85% HR max, 4x/wk for 6 months.	Moderate Exercise n=45 Participants Endurance exercise at 60-65% HR max, 4x/wk for 6 months. Moderate Exercise: Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months.	Total n=128 Participants Total of all reporting groups
Age, Continuous	64 years STANDARD_DEVIATION 10 • n=40 Participants	64 years STANDARD_DEVIATION 9 • n=43 Participants	63 years STANDARD_DEVIATION 10 • n=45 Participants	64 years STANDARD_DEVIATION 9 • n=128 Participants
Sex: Female, Male Female	16 Participants n=40 Participants	21 Participants n=43 Participants	18 Participants n=45 Participants	55 Participants n=128 Participants
Sex: Female, Male Male	24 Participants n=40 Participants	22 Participants n=43 Participants	27 Participants n=45 Participants	73 Participants n=128 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=40 Participants	3 Participants n=43 Participants	2 Participants n=45 Participants	6 Participants n=128 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	39 Participants n=40 Participants	39 Participants n=43 Participants	41 Participants n=45 Participants	119 Participants n=128 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=40 Participants	1 Participants n=43 Participants	2 Participants n=45 Participants	3 Participants n=128 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=40 Participants	0 Participants n=43 Participants	0 Participants n=45 Participants	0 Participants n=128 Participants
Race (NIH/OMB) Asian	2 Participants n=40 Participants	2 Participants n=43 Participants	2 Participants n=45 Participants	6 Participants n=128 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=40 Participants	0 Participants n=43 Participants	0 Participants n=45 Participants	0 Participants n=128 Participants
Race (NIH/OMB) Black or African American	2 Participants n=40 Participants	1 Participants n=43 Participants	2 Participants n=45 Participants	5 Participants n=128 Participants
Race (NIH/OMB) White	36 Participants n=40 Participants	39 Participants n=43 Participants	40 Participants n=45 Participants	115 Participants n=128 Participants
Race (NIH/OMB) More than one race	0 Participants n=40 Participants	0 Participants n=43 Participants	0 Participants n=45 Participants	0 Participants n=128 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=40 Participants	1 Participants n=43 Participants	1 Participants n=45 Participants	2 Participants n=128 Participants
Unified Parkinson Disease Rating Scale Part 3 Motor Evaluation	17 units on a scale STANDARD_DEVIATION 7 • n=40 Participants	17 units on a scale STANDARD_DEVIATION 7 • n=43 Participants	16 units on a scale STANDARD_DEVIATION 7 • n=45 Participants	17 units on a scale STANDARD_DEVIATION 7 • n=128 Participants
Total daily steps	5005 steps per day STANDARD_DEVIATION 2987 • n=36 Participants • Several participants did not wear the activity monitor devices for recording total number of daily steps.	5146 steps per day STANDARD_DEVIATION 3107 • n=36 Participants • Several participants did not wear the activity monitor devices for recording total number of daily steps.	5702 steps per day STANDARD_DEVIATION 2521 • n=42 Participants • Several participants did not wear the activity monitor devices for recording total number of daily steps.	5306 steps per day STANDARD_DEVIATION 2856 • n=114 Participants • Several participants did not wear the activity monitor devices for recording total number of daily steps.
Hoehn and Yahr Stage Stage 1	8 Participants n=40 Participants	12 Participants n=43 Participants	13 Participants n=45 Participants	33 Participants n=128 Participants
Hoehn and Yahr Stage Stage 2	32 Participants n=40 Participants	31 Participants n=43 Participants	32 Participants n=45 Participants	95 Participants n=128 Participants

PRIMARY outcome

Timeframe: 9 to 26 weeks

Population: Only for participants who contributed heart rate monitor data.

Outcome measures

Outcome measures
Measure	Vigorous Exercise n=38 Participants Endurance exercise at 80-85% HR max, 4x/wk for 6 months. Vigorous Exercise: Endurance exercise at 80-85% HR max, 4x/wk for 6 months.	Moderate Exercise n=42 Participants Endurance exercise at 60-65% HR max, 4x/wk for 6 months. Moderate Exercise: Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months.	Moderate Exercise Endurance exercise at 60-65% HR max, 4x/wk for 6 months. Moderate Exercise: Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months.
Percentage of Average Maximum Heart Rate During Exercise as a Measure of Adherence to Exercise	80.3 percentage of maximum heart rate Interval 78.8 to 81.7	65.9 percentage of maximum heart rate Interval 64.2 to 67.7	—

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: Intention to treat; participants were analyzed in the group to which they were assigned. If a participant started medication, the UPDRS measure prior to initiating medication was used even if the 6 month data were not collected. Participants who did not start medications and were missing the 6 month assessment were not included.

Participants were assessed at baseline and at 6 months on their UPDRS. If a participant initiated Parkinson disease medication prior to the 6 month assessment, the UPDRS score from the clinical visit assessment prior to this initiation was used as the score for the individual at 6 months. The change in the UPDRS motor score at 6 months was used as the measure for the futility component of the trial. The change at 6 months was measured as the 6 month value minus the baseline score. A positive change represents worsening of motor symptoms; 0 represents no change; negative values represent improvement. The minimum score on the UPDRS motor is 0 and the maximum is 108 at baseline and 6 months with higher scores representing worse motor symptoms.

Outcome measures

Outcome measures
Measure	Vigorous Exercise n=38 Participants Endurance exercise at 80-85% HR max, 4x/wk for 6 months. Vigorous Exercise: Endurance exercise at 80-85% HR max, 4x/wk for 6 months.	Moderate Exercise n=39 Participants Endurance exercise at 60-65% HR max, 4x/wk for 6 months. Moderate Exercise: Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months.	Moderate Exercise n=42 Participants Endurance exercise at 60-65% HR max, 4x/wk for 6 months. Moderate Exercise: Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months.
6 Month Change in Unified Parkinson's Disease Rating Scale (UPDRS) Motor Score	3.2 units on the UPDRS Motor scale Interval 1.4 to 5.1	0.3 units on the UPDRS Motor scale Interval -1.7 to 2.3	2.0 units on the UPDRS Motor scale Interval 0.4 to 3.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 9 to 26 weeks

Population: Participants were analyzed in the group to which they were assigned. Participants were not included if they did not start the intervention.

The number of days the participant exercised per week

Outcome measures

Outcome measures
Measure	Vigorous Exercise n=40 Participants Endurance exercise at 80-85% HR max, 4x/wk for 6 months. Vigorous Exercise: Endurance exercise at 80-85% HR max, 4x/wk for 6 months.	Moderate Exercise n=45 Participants Endurance exercise at 60-65% HR max, 4x/wk for 6 months. Moderate Exercise: Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months.	Moderate Exercise Endurance exercise at 60-65% HR max, 4x/wk for 6 months. Moderate Exercise: Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months.
Number of Days of Exercise Per Week	2.8 Number of days per week Interval 2.4 to 3.2	3.2 Number of days per week Interval 2.8 to 3.6	—

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Vigorous Exercise

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Moderate Exercise

Serious events: 2 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Control Group n=40 participants at risk Wait listed to moderate or vigorous exercise after 6 months of no exercise. No Intervention: No-exercise control (i.e., usual care);	Vigorous Exercise n=43 participants at risk Endurance exercise at 80-85% HR max, 4x/wk for 6 months. Vigorous Exercise: Endurance exercise at 80-85% HR max, 4x/wk for 6 months.	Moderate Exercise n=45 participants at risk Endurance exercise at 60-65% HR max, 4x/wk for 6 months. Moderate Exercise: Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months.
Renal and urinary disorders Renal calculi	0.00% 0/40 • Adverse event data were collected monthly until the primary time point at 6 months.	0.00% 0/43 • Adverse event data were collected monthly until the primary time point at 6 months.	2.2% 1/45 • Number of events 1 • Adverse event data were collected monthly until the primary time point at 6 months.
Gastrointestinal disorders Gastric ulcer	0.00% 0/40 • Adverse event data were collected monthly until the primary time point at 6 months.	0.00% 0/43 • Adverse event data were collected monthly until the primary time point at 6 months.	2.2% 1/45 • Number of events 1 • Adverse event data were collected monthly until the primary time point at 6 months.

Other adverse events

Additional Information

Dr. Charity G. Moore

University of Pittsburgh

Phone: 412-383-6630

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Control Group n=40 participants at risk Wait listed to moderate or vigorous exercise after 6 months of no exercise. No Intervention: No-exercise control (i.e., usual care);	Vigorous Exercise n=43 participants at risk Endurance exercise at 80-85% HR max, 4x/wk for 6 months. Vigorous Exercise: Endurance exercise at 80-85% HR max, 4x/wk for 6 months.	Moderate Exercise n=45 participants at risk Endurance exercise at 60-65% HR max, 4x/wk for 6 months. Moderate Exercise: Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	0.00% 0/40 • Adverse event data were collected monthly until the primary time point at 6 months.	2.3% 1/43 • Number of events 1 • Adverse event data were collected monthly until the primary time point at 6 months.	0.00% 0/45 • Adverse event data were collected monthly until the primary time point at 6 months.
Cardiac disorders Palpitations	0.00% 0/40 • Adverse event data were collected monthly until the primary time point at 6 months.	0.00% 0/43 • Adverse event data were collected monthly until the primary time point at 6 months.	2.2% 1/45 • Number of events 1 • Adverse event data were collected monthly until the primary time point at 6 months.
Gastrointestinal disorders Diarrhea	0.00% 0/40 • Adverse event data were collected monthly until the primary time point at 6 months.	2.3% 1/43 • Number of events 1 • Adverse event data were collected monthly until the primary time point at 6 months.	0.00% 0/45 • Adverse event data were collected monthly until the primary time point at 6 months.
Gastrointestinal disorders Gastric ulcer	0.00% 0/40 • Adverse event data were collected monthly until the primary time point at 6 months.	0.00% 0/43 • Adverse event data were collected monthly until the primary time point at 6 months.	2.2% 1/45 • Number of events 1 • Adverse event data were collected monthly until the primary time point at 6 months.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	0.00% 0/40 • Adverse event data were collected monthly until the primary time point at 6 months.	2.3% 1/43 • Number of events 1 • Adverse event data were collected monthly until the primary time point at 6 months.	0.00% 0/45 • Adverse event data were collected monthly until the primary time point at 6 months.
General disorders Flu like symptoms	0.00% 0/40 • Adverse event data were collected monthly until the primary time point at 6 months.	0.00% 0/43 • Adverse event data were collected monthly until the primary time point at 6 months.	6.7% 3/45 • Number of events 3 • Adverse event data were collected monthly until the primary time point at 6 months.
Infections and infestations Bladder infection	0.00% 0/40 • Adverse event data were collected monthly until the primary time point at 6 months.	2.3% 1/43 • Number of events 1 • Adverse event data were collected monthly until the primary time point at 6 months.	0.00% 0/45 • Adverse event data were collected monthly until the primary time point at 6 months.
Infections and infestations Lung infection	0.00% 0/40 • Adverse event data were collected monthly until the primary time point at 6 months.	0.00% 0/43 • Adverse event data were collected monthly until the primary time point at 6 months.	2.2% 1/45 • Number of events 1 • Adverse event data were collected monthly until the primary time point at 6 months.
Infections and infestations Rhinitis infective	2.5% 1/40 • Number of events 1 • Adverse event data were collected monthly until the primary time point at 6 months.	0.00% 0/43 • Adverse event data were collected monthly until the primary time point at 6 months.	0.00% 0/45 • Adverse event data were collected monthly until the primary time point at 6 months.
Infections and infestations Skin infection	0.00% 0/40 • Adverse event data were collected monthly until the primary time point at 6 months.	2.3% 1/43 • Number of events 1 • Adverse event data were collected monthly until the primary time point at 6 months.	0.00% 0/45 • Adverse event data were collected monthly until the primary time point at 6 months.
Infections and infestations Upper respiratory infection	2.5% 1/40 • Number of events 1 • Adverse event data were collected monthly until the primary time point at 6 months.	7.0% 3/43 • Number of events 3 • Adverse event data were collected monthly until the primary time point at 6 months.	0.00% 0/45 • Adverse event data were collected monthly until the primary time point at 6 months.
Infections and infestations Urinary tract infection	0.00% 0/40 • Adverse event data were collected monthly until the primary time point at 6 months.	0.00% 0/43 • Adverse event data were collected monthly until the primary time point at 6 months.	4.4% 2/45 • Number of events 2 • Adverse event data were collected monthly until the primary time point at 6 months.
Injury, poisoning and procedural complications Fall	22.5% 9/40 • Number of events 11 • Adverse event data were collected monthly until the primary time point at 6 months.	14.0% 6/43 • Number of events 13 • Adverse event data were collected monthly until the primary time point at 6 months.	11.1% 5/45 • Number of events 7 • Adverse event data were collected monthly until the primary time point at 6 months.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, specify	0.00% 0/40 • Adverse event data were collected monthly until the primary time point at 6 months.	0.00% 0/43 • Adverse event data were collected monthly until the primary time point at 6 months.	6.7% 3/45 • Number of events 3 • Adverse event data were collected monthly until the primary time point at 6 months.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/40 • Adverse event data were collected monthly until the primary time point at 6 months.	4.7% 2/43 • Number of events 2 • Adverse event data were collected monthly until the primary time point at 6 months.	0.00% 0/45 • Adverse event data were collected monthly until the primary time point at 6 months.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/40 • Adverse event data were collected monthly until the primary time point at 6 months.	2.3% 1/43 • Number of events 1 • Adverse event data were collected monthly until the primary time point at 6 months.	0.00% 0/45 • Adverse event data were collected monthly until the primary time point at 6 months.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/40 • Adverse event data were collected monthly until the primary time point at 6 months.	9.3% 4/43 • Number of events 4 • Adverse event data were collected monthly until the primary time point at 6 months.	0.00% 0/45 • Adverse event data were collected monthly until the primary time point at 6 months.
Musculoskeletal and connective tissue disorders Buttock pain	0.00% 0/40 • Adverse event data were collected monthly until the primary time point at 6 months.	0.00% 0/43 • Adverse event data were collected monthly until the primary time point at 6 months.	2.2% 1/45 • Number of events 1 • Adverse event data were collected monthly until the primary time point at 6 months.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/40 • Adverse event data were collected monthly until the primary time point at 6 months.	0.00% 0/43 • Adverse event data were collected monthly until the primary time point at 6 months.	2.2% 1/45 • Number of events 1 • Adverse event data were collected monthly until the primary time point at 6 months.
Musculoskeletal and connective tissue disorders Neck pain	2.5% 1/40 • Number of events 1 • Adverse event data were collected monthly until the primary time point at 6 months.	0.00% 0/43 • Adverse event data were collected monthly until the primary time point at 6 months.	2.2% 1/45 • Number of events 1 • Adverse event data were collected monthly until the primary time point at 6 months.
Musculoskeletal and connective tissue disorders Pain in extremity	2.5% 1/40 • Number of events 1 • Adverse event data were collected monthly until the primary time point at 6 months.	18.6% 8/43 • Number of events 9 • Adverse event data were collected monthly until the primary time point at 6 months.	6.7% 3/45 • Number of events 3 • Adverse event data were collected monthly until the primary time point at 6 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	2.5% 1/40 • Number of events 1 • Adverse event data were collected monthly until the primary time point at 6 months.	0.00% 0/43 • Adverse event data were collected monthly until the primary time point at 6 months.	2.2% 1/45 • Number of events 1 • Adverse event data were collected monthly until the primary time point at 6 months.
Nervous system disorders Nervous system disorders - Other, specify	0.00% 0/40 • Adverse event data were collected monthly until the primary time point at 6 months.	0.00% 0/43 • Adverse event data were collected monthly until the primary time point at 6 months.	2.2% 1/45 • Number of events 1 • Adverse event data were collected monthly until the primary time point at 6 months.
Renal and urinary disorders Renal calculi	0.00% 0/40 • Adverse event data were collected monthly until the primary time point at 6 months.	0.00% 0/43 • Adverse event data were collected monthly until the primary time point at 6 months.	2.2% 1/45 • Number of events 1 • Adverse event data were collected monthly until the primary time point at 6 months.
Renal and urinary disorders Urine discoloration	0.00% 0/40 • Adverse event data were collected monthly until the primary time point at 6 months.	0.00% 0/43 • Adverse event data were collected monthly until the primary time point at 6 months.	2.2% 1/45 • Number of events 1 • Adverse event data were collected monthly until the primary time point at 6 months.
Respiratory, thoracic and mediastinal disorders Cough	2.5% 1/40 • Number of events 1 • Adverse event data were collected monthly until the primary time point at 6 months.	2.3% 1/43 • Number of events 1 • Adverse event data were collected monthly until the primary time point at 6 months.	2.2% 1/45 • Number of events 1 • Adverse event data were collected monthly until the primary time point at 6 months.
Respiratory, thoracic and mediastinal disorders Sore throat	0.00% 0/40 • Adverse event data were collected monthly until the primary time point at 6 months.	2.3% 1/43 • Number of events 1 • Adverse event data were collected monthly until the primary time point at 6 months.	0.00% 0/45 • Adverse event data were collected monthly until the primary time point at 6 months.
Skin and subcutaneous tissue disorders Dry skin	2.5% 1/40 • Number of events 1 • Adverse event data were collected monthly until the primary time point at 6 months.	0.00% 0/43 • Adverse event data were collected monthly until the primary time point at 6 months.	0.00% 0/45 • Adverse event data were collected monthly until the primary time point at 6 months.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	2.5% 1/40 • Number of events 1 • Adverse event data were collected monthly until the primary time point at 6 months.	0.00% 0/43 • Adverse event data were collected monthly until the primary time point at 6 months.	2.2% 1/45 • Number of events 1 • Adverse event data were collected monthly until the primary time point at 6 months.
Surgical and medical procedures Surgical and medical procedures - Other, specify	2.5% 1/40 • Number of events 1 • Adverse event data were collected monthly until the primary time point at 6 months.	0.00% 0/43 • Adverse event data were collected monthly until the primary time point at 6 months.	6.7% 3/45 • Number of events 3 • Adverse event data were collected monthly until the primary time point at 6 months.
Vascular disorders Hypertension	0.00% 0/40 • Adverse event data were collected monthly until the primary time point at 6 months.	0.00% 0/43 • Adverse event data were collected monthly until the primary time point at 6 months.	2.2% 1/45 • Number of events 1 • Adverse event data were collected monthly until the primary time point at 6 months.