Exercise Interventions in Parkinson's Disease
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson's Disease |
Behavioral: Exercise Programme Behavioral: Hand Writing programme |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Longer-term Exercise Interventions in People With Parkinson's Disease |
- Change in Two minute walk from baseline at 3 months [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]Distance covered in 2 minutes by walking at self selected speed
- Change in Two minute walk from 3 months at 6 months [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]Distance covered in 2 minutes by walking at self selected speed
- Change in Two minute walk from 6 months at 12 months [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]Distance covered in 2 minutes by walking at self selected speed
- Change in Time Up and Go (TUG) from baseline at 3 months [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]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 baseline at 3 months [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]Time taken to place 9 pegs in 9 holes and remove them
- Change in SF-36 from baseline at 3 months [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]General Health status questionnaire
- Change in EQ-5D from baseline at 3 months [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]Quality of life questionnaire
- Change in Prescribed medication from baseline at 3 months [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]Prescribed medication regime
- Change in Blood Pressure from baseline at 3 months [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]Systolic and diastolic non-invasive blood pressure
- Change in Body Mass Index from baseline at 3 months [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]Weight (kg)/ Height (m) ^2
- Change in aerobic fitness from baseline at 3 months [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]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 [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]Leg power measured on the Nottingham leg power rig
- Change in Grip Strength from baseline at 3 months [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]Grip strength measured by a dynamometer
- Change in Disease Status from baseline at 3 months [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]Disease Status measured by Unified Parkinson's Disease Rating Scale
- Change in Non-motor symptoms from baseline at 3 months [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]measured by the Non motor symptoms questionnaire
- change in reported Physical Activity from baseline at 3 months [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]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 [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]Activity measured by an ankle worn accelerometer (steps and step intensity) over seven days
- Process Evaluation [ Time Frame: 6 months (end intervention) ] [ Designated as safety issue: No ]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 [ Time Frame: Particpants will be followed at each scheduled session for the duration of the intervention (6 months 2 x a week) ] [ Designated as safety issue: No ]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 [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]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 [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]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 [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]Time taken to place 9 pegs in 9 holes and remove them
- Change in Nine hole peg test from 6 months at 12 months [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]Time taken to place 9 pegs in 9 holes and remove them
- Change in SF-36 from 6 months at 12 months [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]General Health status questionnaire
- Change in SF-36 from 3 months at 6 months [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]General Health status questionnaire
- Change in EQ-5D from 3 months at 6 months [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]Quality of life questionnaire
- Change in EQ-5D from 6 months at 12 months [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]Quality of life questionnaire
- Change in Prescribed medication from 3 months at 6 months [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]Prescribed medication regime
- Change in Prescribed medication from 6 months at 12 months [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]Prescribed medication regime
- Change in Blood Pressure from 3 months at 6 months [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]Systolic and diastolic non-invasive blood pressure
- Change in Blood Pressure from 6 months at 12 months [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]Systolic and diastolic non-invasive blood pressure
- Change in Body Mass Index from 6 months at 12 months [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]Weight (kg)/ Height (m) ^2
- Change in aerobic fitness from 6 months at 12 months [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]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 [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]Leg power measured on the Nottingham leg power rig
- Change in Leg power from 6 months at 12 months [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]Leg power measured on the Nottingham leg power rig
- Change in Grip Strength from 3 months at 6 months [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]Grip strength measured by a dynamometer
- Change in Grip Strength from 6 months at 12 months [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]Grip strength measured by a dynamometer
- Change in Disease Status from 3 months at 6 months [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]Disease Status measured by Unified Parkinson's Disease Rating Scale
- Change in Disease Status from 6 months at 12 months [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]Disease Status measured by Unified Parkinson's Disease Rating Scale
- Change in Non-motor symptoms from 3 months at 6 months [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]measured by the Non motor symptoms questionnaire
- Change in Non-motor symptoms from 6 months at 12 months [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]measured by the Non motor symptoms questionnaire
- Change in reported Physical Activity from 3 months at 6 months [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]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 [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]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 [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]Activity measured by an ankle worn accelerometer (steps and step intensity) over seven days
- Change measured physical activity from 6 months at 12 months [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]Activity measured by an ankle worn accelerometer (steps and step intensity) over seven days
- Change in FSS from baseline at 3 months [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]Fatigue measured using the FSS (Fatigue Severity Scale)
- Change in FSS from 3 months at 6 months [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]Fatigue measured using the FSS (Fatigue Severity Scale)
- Change in FSS from 6 months at 12 months [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]Fatigue measured using the FSS (Fatigue Severity Scale)
- Change upper limb function from baseline at 3 months [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]upper limb function of movement time, reaction time and movement error using a touch scene PC
- Change upper limb function from 3 months at 6 months [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]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 [ Time Frame: 6 months and12months ] [ Designated as safety issue: No ]upper limb function of movement time, reaction time and movement error using a touch scene PC
| Estimated Enrollment: | 100 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
Behavioral: 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
|
|
Active Comparator: Hand writing programme
6 months 2 x a week hand writing practice. Performed in the home supported by a physiotherapist (5 support sessions)
|
Behavioral: Hand Writing programme
6 months 2 x a week hand writing practice. Performed in the home supported by a physiotherapist (5 support sessions)
|
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:
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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;
Contacts and Locations| Contact: Marloes Franssesn, Msc | +44 (0)1865 483272 ext 3272 | marloes.franssen-2011@brookes.ac.uk |
| Contact: Johnny Collett, PhD | +44 (0)1865 483630 ext 3630 | jcollett@brookes.ac.uk |
| United Kingdom | |
| Oxford Brookes University | Recruiting |
| Oxford, Oxfordshire, United Kingdom, OX3 0SB | |
| Contact: marloes franssen, BSc, MSc +44 (0)1865 483272 ext 3272 marloes.franssen-2011@brookes.ac.uk | |
| Contact: Johnny Collett, BSc, PhD +44 (0)1865 483630 ext 3630 jcollett@brookes.ac.uk | |
| Principal Investigator: Helen Dawes, PhD | |
| Sub-Investigator: Johnny Collett, PhD | |
| Sub-Investigator: Charlotte Windward, MSc | |
| Sub-Investigator: marloes. franssen, MSc | |
| Principal Investigator: | Helen Dawes, PhD | Oxford Brookes University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Dr Johnny Collett, Research Fellow, Oxford Brookes University |
| ClinicalTrials.gov Identifier: | NCT01439022 History of Changes |
| Other Study ID Numbers: | MSG_EXPD_11/SC/0267 |
| Study First Received: | September 15, 2011 |
| Last Updated: | September 28, 2012 |
| Health Authority: | United Kingdom: National Institute for Health Research United Kingdom: Research Ethics Committee |
Keywords provided by Oxford Brookes University:
|
Parkinson's Disease Exercise Treatment Outcome Patient Adherence |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |
ClinicalTrials.gov processed this record on May 16, 2013