Exercise Interventions in Parkinson's Disease

Study Overview
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Brief Summary
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This study sets out to determine the effect of exercise performed over a longer period of time (6 months), delivered using community facilities, on motor and non motor symptoms, health and well being in people with Parkinson's Disease.

Detailed Description
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Participation in exercise is beneficial for health and well being, but the effect over a longer period of time in people with Parkinson's disease (PD) has not been established. People with PD currently only receive short-term support for exercise therapy interventions funded from the National Health Service; it is therefore unsurprising that people with PD are observed to have low levels of physical activity that decrease over time. Using mixed methodology the investigators will explore the effect of exercise delivered over a longer period of time (six months) in people with PD. The investigators will examine the views of people participating in the program. Aims Using a randomized controlled trial with one intervention arm and an active comparator control group with blinded assessments and semi-structured interview techniques the investigators will determine in people with PD: The effect of longer-term exercise participation on motor symptoms The effect of longer-term exercise participation on non motor symptoms, fitness, health and well being. Participants views of the process and sustainability of community provision of exercise over a longer period of time.

Official Title
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Longer-term Exercise Interventions in People With Parkinson's Disease

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Behavioral: Exercise Programme
* Behavioral: Hand Writing programme


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parkinson's disease diagnosed by neurological examination; idiopathic PD defined by the UK Parkinson's Disease Society Brain Bank Criteria Able to walk ≥ 100m maintained a stable medical regime for 12 weeks prior to initiation of the study, and anticipated to maintain a stable regime for the course of study (as determined by the referring clinician). Exclusion Criteria: Dementia History of additional prior neurological condition Severe depression or psychosis or a mental state that would preclude consistent active involvement with the study over its duration Cardiac precautions that would prevent the subject from completing the exercise program or the full battery of outcome measures Any known contraindication to exercise Reduced cognition of any cause [Minimental state examination [(MMSE) < 23] An orthopaedic condition that independently limits walking;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Programme<br>6 months 2 x a week aerobic and anaerobic exercise delivered in community facilities by an exercise professional and supported by a physiotherapist. | Behavioral: Exercise Programme<br>* 6 months 2 x a week aerobic and anaerobic exercise delivered in community facilities by an exercise professional and supported by a physiotherapist<br>|
| Active Comparator: Hand writing programme<br>6 months 2 x a week hand writing practice. Performed in the home supported by a physiotherapist (5 support sessions) | Behavioral: Hand Writing programme<br>* 6 months 2 x a week hand writing practice. Performed in the home supported by a physiotherapist (5 support sessions)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Two minute walk from baseline at 3 months | Distance covered in 2 minutes by walking at self selected speed | baseline and 3 months | 
| Change in Two minute walk from 3 months at 6 months | Distance covered in 2 minutes by walking at self selected speed | 3 months and 6 months | 
| Change in Two minute walk from 6 months at 12 months | Distance covered in 2 minutes by walking at self selected speed | 6 months and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Time Up and Go (TUG) from baseline at 3 months | Time taken to sit to stand from a chair , walk 3 meters, turn and return to sitting in the chair. At normal speed | baseline and 3 months | 
| Change in Nine hole peg test from baseline at 3 months | Time taken to place 9 pegs in 9 holes and remove them | baseline and 3 months | 
| Change in SF-36 from baseline at 3 months | General Health status questionnaire | baseline and 3 months | 
| Change in EQ-5D from baseline at 3 months | Quality of life questionnaire | Baseline and 3 months | 
| Change in Prescribed medication from baseline at 3 months | Prescribed medication regime | baseline and 3 months | 
| Change in Blood Pressure from baseline at 3 months | Systolic and diastolic non-invasive blood pressure | baseline and 3 months | 
| Change in Body Mass Index from baseline at 3 months | Weight (kg)/ Height (m) ^2 | baseline and 3 months | 
| Change in aerobic fitness from baseline at 3 months | An incremental cycle ergometer exercise test. (Heart rate, blood pressure, rating of perception of effort, rate of oxygen consumption (metabolism) from measures of expired air will be measured at the beginning, each increment and at the end of the test | baseline and 3 months | 
| Change in Leg power from baseline at 3 months | Leg power measured on the Nottingham leg power rig | baseline and 3 months | 
| Change in Grip Strength from baseline at 3 months | Grip strength measured by a dynamometer | baseline and 3 months | 
| Change in Disease Status from baseline at 3 months | Disease Status measured by Unified Parkinson's Disease Rating Scale | baseline and 3 months | 
| Change in Non-motor symptoms from baseline at 3 months | measured by the Non motor symptoms questionnaire | baseline and 3 months | 
| change in reported Physical Activity from baseline at 3 months | Self reported retrospective physical activity in social, work and home domains. Measured by the Physical Activity Scale for the Elderly questionnaire | baseline and 3 months | 
| Change measured physical activity from baseline at 3 months | Activity measured by an ankle worn accelerometer (steps and step intensity) over seven days | baseline and 3 months | 
| Process Evaluation | participant interviews on the perceived results and experiences/process. Interviews will be digitally audio-recorded. An interview schedule will be used to guide content. A standard thematic analysis technique will be used. The transcripts will be examined to identify themes and categories. | 6 months (end intervention) | 
| Adherence | Exercise Programme: Attendance at exercise sessions and session content (Heart Rate, Rating of perceived Exertion and duration, speed and repetition of exercises)(6 months 2 x a week). Hand writing Programme: Diary of hand writing practice (6 months 2 x a week) | Particpants will be followed at each scheduled session for the duration of the intervention (6 months 2 x a week) | 
| Change in Time Up and Go (TUG) from 3 months at 6 months | Time taken to sit to stand from a chair , walk 3 meters, turn and return to sitting in the chair. At normal speed | 3 months and 6 months | 
| Change in Time Up and Go (TUG) from 6 months at 12 months | Time taken to sit to stand from a chair , walk 3 meters, turn and return to sitting in the chair. At normal speed | 6 months and 12 months | 
| Change in Nine hole peg test from 3 months at 6 months | Time taken to place 9 pegs in 9 holes and remove them | 3 months and 6 months | 
| Change in Nine hole peg test from 6 months at 12 months | Time taken to place 9 pegs in 9 holes and remove them | 6 months and 12 months | 
| Change in SF-36 from 6 months at 12 months | General Health status questionnaire | 6 months and 12 months | 
| Change in SF-36 from 3 months at 6 months | General Health status questionnaire | 3 months and 6 months | 
| Change in EQ-5D from 3 months at 6 months | Quality of life questionnaire | 3 months and 6 months | 
| Change in EQ-5D from 6 months at 12 months | Quality of life questionnaire | 6 months and 12 months | 
| Change in Prescribed medication from 3 months at 6 months | Prescribed medication regime | 3 months and 6 months | 
| Change in Prescribed medication from 6 months at 12 months | Prescribed medication regime | 6 months and 12 months | 
| Change in Blood Pressure from 3 months at 6 months | Systolic and diastolic non-invasive blood pressure | 3 months and 6 months | 
| Change in Blood Pressure from 6 months at 12 months | Systolic and diastolic non-invasive blood pressure | 6 months and 12 months | 
| Change in Body Mass Index from 6 months at 12 months | Weight (kg)/ Height (m) ^2 | 6 months and 12 months | 
| Change in aerobic fitness from 6 months at 12 months | An incremental cycle ergometer exercise test. (Heart rate, blood pressure, rating of perception of effort, rate of oxygen consumption (metabolism) from measures of expired air will be measured at the beginning, each increment and at the end of the test | 6 months and 12 months | 
| Change in Leg power from 3 months at 6 months | Leg power measured on the Nottingham leg power rig | 3 months and 6 months | 
| Change in Leg power from 6 months at 12 months | Leg power measured on the Nottingham leg power rig | 6 months and 12 months | 
| Change in Grip Strength from 3 months at 6 months | Grip strength measured by a dynamometer | 3 months and 6 months | 
| Change in Grip Strength from 6 months at 12 months | Grip strength measured by a dynamometer | 6 months and 12 months | 
| Change in Disease Status from 3 months at 6 months | Disease Status measured by Unified Parkinson's Disease Rating Scale | 3 months and 6 months | 
| Change in Disease Status from 6 months at 12 months | Disease Status measured by Unified Parkinson's Disease Rating Scale | 6 months and 12 months | 
| Change in Non-motor symptoms from 3 months at 6 months | measured by the Non motor symptoms questionnaire | 3 months and 6 months | 
| Change in Non-motor symptoms from 6 months at 12 months | measured by the Non motor symptoms questionnaire | 6 months and 12 months | 
| Change in reported Physical Activity from 3 months at 6 months | Self reported retrospective physical activity in social, work and home domains. Measured by the Physical Activity Scale for the Elderly questionnaire | 3 months and 6 months | 
| Change in reported Physical Activity from 6 months at 12 months | Self reported retrospective physical activity in social, work and home domains. Measured by the Physical Activity Scale for the Elderly questionnaire | 6 months and 12 months | 
| Change measured physical activity from 3 months at 6 months | Activity measured by an ankle worn accelerometer (steps and step intensity) over seven days | 3 months and 6 months | 
| Change measured physical activity from 6 months at 12 months | Activity measured by an ankle worn accelerometer (steps and step intensity) over seven days | 6 months and 12 months | 
| Change in FSS from baseline at 3 months | Fatigue measured using the FSS (Fatigue Severity Scale) | baseline and 3 months | 
| Change in FSS from 3 months at 6 months | Fatigue measured using the FSS (Fatigue Severity Scale) | 3 months and 6 months | 
| Change in FSS from 6 months at 12 months | Fatigue measured using the FSS (Fatigue Severity Scale) | 6 months and 12 months | 
| Change upper limb function from baseline at 3 months | upper limb function of movement time, reaction time and movement error using a touch scene PC | baseline and 3 months | 
| Change upper limb function from 3 months at 6 months | upper limb function of movement time, reaction time and movement error using a touch scene PC | 3 months and 6 months | 
| Change upper limb function from 6 months at 12 months | upper limb function of movement time, reaction time and movement error using a touch scene PC | 6 months and12months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's Disease, Exercise, Treatment Outcome, Patient Adherence