Exercise Interventions in Parkinson's Disease
- Conditions
- Parkinson's Disease
- Interventions
- Behavioral: Exercise ProgrammeBehavioral: Hand Writing programme
- Registration Number
- NCT01439022
- Lead Sponsor
- Oxford Brookes University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 105
- 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).
- 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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exercise Programme Exercise Programme 6 months 2 x a week aerobic and anaerobic exercise delivered in community facilities by an exercise professional and supported by a physiotherapist. Hand writing programme Hand Writing programme 6 months 2 x a week hand writing practice. Performed in the home supported by a physiotherapist (5 support sessions)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Change in Blood Pressure from baseline at 3 months baseline and 3 months Systolic and diastolic non-invasive blood pressure
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 Disease Status from baseline at 3 months baseline and 3 months Disease Status measured by Unified Parkinson's Disease Rating Scale
Change in SF-36 from baseline at 3 months baseline and 3 months General Health status questionnaire
Change in EQ-5D from baseline at 3 months Baseline and 3 months Quality of life questionnaire
Change in Body Mass Index from baseline at 3 months baseline and 3 months Weight (kg)/ Height (m) \^2
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 Prescribed medication from baseline at 3 months baseline and 3 months Prescribed medication regime
Change in Leg power from baseline at 3 months baseline and 3 months Leg power measured on the Nottingham leg power rig
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
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 EQ-5D from 3 months at 6 months 3 months and 6 months Quality of life questionnaire
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 Grip Strength from baseline at 3 months baseline and 3 months Grip strength measured by a dynamometer
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 Prescribed medication from 3 months at 6 months 3 months and 6 months Prescribed medication regime
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 Blood Pressure from 6 months at 12 months 6 months and 12 months Systolic and diastolic non-invasive blood pressure
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
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.
Change in Blood Pressure from 3 months at 6 months 3 months and 6 months Systolic and diastolic non-invasive blood pressure
Change in Grip Strength from 3 months at 6 months 3 months and 6 months Grip strength measured by a dynamometer
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 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 SF-36 from 3 months at 6 months 3 months and 6 months General Health status questionnaire
Change in Body Mass Index from 6 months at 12 months 6 months and 12 months Weight (kg)/ Height (m) \^2
Change in EQ-5D from 6 months at 12 months 6 months and 12 months Quality of life questionnaire
Change in Prescribed medication from 6 months at 12 months 6 months and 12 months Prescribed medication regime
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 6 months at 12 months 6 months and 12 months Grip strength measured by a dynamometer
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 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 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 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 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 baseline at 3 months baseline and 3 months Fatigue measured using the FSS (Fatigue Severity Scale)
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 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 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
Trial Locations
- Locations (1)
Oxford Brookes University
🇬🇧Oxford, Oxfordshire, United Kingdom