Exercise Interventions in Parkinson's Disease

Sponsor

Oxford Brookes University (Other)

Overall Status

Completed

CT.gov ID

NCT01439022

Collaborator

National Institute for Health Research, United Kingdom (Other), Royal Berkshire NHS Foundation Trust (participant identification centre) (Other), Nuffield Orthopaedic Centre NHS Trust (participant identification centre) (Other)

105

Enrollment

Location

Arms

Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease	Behavioral: Exercise Programme Behavioral: Hand Writing programme	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

105 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2011

Actual Primary Completion Date :

Sep 1, 2014

Actual Study Completion Date :

Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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)

Arm

Intervention/Treatment

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)

Outcome Measures

Primary Outcome Measures

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

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 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
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 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 baseline at 3 months [baseline and 3 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 in FSS from 6 months at 12 months [6 months and 12 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 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;