Parkinson's Disease
Conditions
Keywords
Parkinson's Disease, Exercise, Treatment Outcome, Patient Adherence
Brief summary
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
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: 1. The effect of longer-term exercise participation on motor symptoms 2. The effect of longer-term exercise participation on non motor symptoms, fitness, health and well being. 3. Participants views of the process and sustainability of community provision of exercise over a longer period of time.
Interventions
BEHAVIORALExercise Programme
6 months 2 x a week aerobic and anaerobic exercise delivered in community facilities by an exercise professional and supported by a physiotherapist
BEHAVIORALHand Writing programme
6 months 2 x a week hand writing practice. Performed in the home supported by a physiotherapist (5 support sessions)
Sponsors
National Institute for Health Research, United Kingdom
Royal Berkshire NHS Foundation Trust (participant identification centre)
Nuffield Orthopaedic Centre NHS Trust (participant identification centre)
Oxford Brookes University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Two minute walk from baseline at 3 months | baseline and 3 months | Distance covered in 2 minutes by walking at self selected speed |
| Change in Two minute walk from 3 months at 6 months | 3 months and 6 months | Distance covered in 2 minutes by walking at self selected speed |
| Change in Two minute walk from 6 months at 12 months | 6 months and 12 months | Distance covered in 2 minutes by walking at self selected speed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in EQ-5D from baseline at 3 months | Baseline and 3 months | Quality of life questionnaire |
| Change in Prescribed medication from baseline at 3 months | baseline and 3 months | Prescribed medication regime |
| Change in Blood Pressure from baseline at 3 months | baseline and 3 months | Systolic and diastolic non-invasive blood pressure |
| Change in Body Mass Index from baseline at 3 months | baseline and 3 months | Weight (kg)/ Height (m) \^2 |
| Change upper limb function from baseline at 3 months | baseline and 3 months | upper limb function of movement time, reaction time and movement error using a touch scene PC |
| Change in Time Up and Go (TUG) from baseline at 3 months | baseline and 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 |
| Change in aerobic fitness from baseline at 3 months | baseline and 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 |
| Change in Leg power from baseline at 3 months | baseline and 3 months | Leg power measured on the Nottingham leg power rig |
| Change in Grip Strength from baseline at 3 months | baseline and 3 months | Grip strength measured by a dynamometer |
| Change in Disease Status from baseline at 3 months | baseline and 3 months | Disease Status measured by Unified Parkinson's Disease Rating Scale |
| Change in Non-motor symptoms from baseline at 3 months | baseline and 3 months | measured by the Non motor symptoms questionnaire |
| change in reported Physical Activity from baseline at 3 months | baseline and 3 months | Self reported retrospective physical activity in social, work and home domains. Measured by the Physical Activity Scale for the Elderly questionnaire |
| Change measured physical activity from baseline at 3 months | baseline and 3 months | Activity measured by an ankle worn accelerometer (steps and step intensity) over seven days |
| Process Evaluation | 6 months (end intervention) | 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. |
| Adherence | Particpants will be followed at each scheduled session for the duration of the intervention (6 months 2 x a week) | 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) |
| Change in Time Up and Go (TUG) from 3 months at 6 months | 3 months and 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 |
| Change in Time Up and Go (TUG) from 6 months at 12 months | 6 months and 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 |
| Change in Nine hole peg test from 3 months at 6 months | 3 months and 6 months | Time taken to place 9 pegs in 9 holes and remove them |
| Change in Nine hole peg test from 6 months at 12 months | 6 months and 12 months | Time taken to place 9 pegs in 9 holes and remove them |
| Change in SF-36 from 6 months at 12 months | 6 months and 12 months | General Health status questionnaire |
| Change in SF-36 from 3 months at 6 months | 3 months and 6 months | General Health status questionnaire |
| Change in EQ-5D from 3 months at 6 months | 3 months and 6 months | Quality of life questionnaire |
| Change in EQ-5D from 6 months at 12 months | 6 months and 12 months | Quality of life questionnaire |
| Change in Prescribed medication from 3 months at 6 months | 3 months and 6 months | Prescribed medication regime |
| Change in Prescribed medication from 6 months at 12 months | 6 months and 12 months | Prescribed medication regime |
| Change in Blood Pressure from 3 months at 6 months | 3 months and 6 months | Systolic and diastolic non-invasive blood pressure |
| Change in Blood Pressure from 6 months at 12 months | 6 months and 12 months | Systolic and diastolic non-invasive blood pressure |
| Change in Body Mass Index from 6 months at 12 months | 6 months and 12 months | Weight (kg)/ Height (m) \^2 |
| Change in aerobic fitness from 6 months at 12 months | 6 months and 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 |
| Change in Leg power from 3 months at 6 months | 3 months and 6 months | Leg power measured on the Nottingham leg power rig |
| Change in Leg power from 6 months at 12 months | 6 months and 12 months | Leg power measured on the Nottingham leg power rig |
| Change in Grip Strength from 3 months at 6 months | 3 months and 6 months | Grip strength measured by a dynamometer |
| Change in Grip Strength from 6 months at 12 months | 6 months and 12 months | Grip strength measured by a dynamometer |
| Change in Disease Status from 3 months at 6 months | 3 months and 6 months | Disease Status measured by Unified Parkinson's Disease Rating Scale |
| Change in Disease Status from 6 months at 12 months | 6 months and 12 months | Disease Status measured by Unified Parkinson's Disease Rating Scale |
| Change in Non-motor symptoms from 3 months at 6 months | 3 months and 6 months | measured by the Non motor symptoms questionnaire |
| Change in Non-motor symptoms from 6 months at 12 months | 6 months and 12 months | measured by the Non motor symptoms questionnaire |
| Change in reported Physical Activity from 3 months at 6 months | 3 months and 6 months | Self reported retrospective physical activity in social, work and home domains. Measured by the Physical Activity Scale for the Elderly questionnaire |
| Change in reported Physical Activity from 6 months at 12 months | 6 months and 12 months | Self reported retrospective physical activity in social, work and home domains. Measured by the Physical Activity Scale for the Elderly questionnaire |
| Change measured physical activity from 3 months at 6 months | 3 months and 6 months | Activity measured by an ankle worn accelerometer (steps and step intensity) over seven days |
| Change measured physical activity from 6 months at 12 months | 6 months and 12 months | Activity measured by an ankle worn accelerometer (steps and step intensity) over seven days |
| Change in FSS from 6 months at 12 months | 6 months and 12 months | Fatigue measured using the FSS (Fatigue Severity Scale) |
| Change in FSS from 3 months at 6 months | 3 months and 6 months | Fatigue measured using the FSS (Fatigue Severity Scale) |
| Change upper limb function from 3 months at 6 months | 3 months and 6 months | upper limb function of movement time, reaction time and movement error using a touch scene PC |
| Change upper limb function from 6 months at 12 months | 6 months and12months | upper limb function of movement time, reaction time and movement error using a touch scene PC |
| Change in FSS from baseline at 3 months | baseline and 3 months | Fatigue measured using the FSS (Fatigue Severity Scale) |
| Change in Nine hole peg test from baseline at 3 months | baseline and 3 months | Time taken to place 9 pegs in 9 holes and remove them |
| Change in SF-36 from baseline at 3 months | baseline and 3 months | General Health status questionnaire |
Countries
United Kingdom
Outcome results
None listed