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Exercise Interventions in Parkinson's Disease

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Exercise Programme
Hand Writing programme
Sponsored by
Oxford Brookes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's Disease, Exercise, Treatment Outcome, Patient Adherence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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;

Sites / Locations

  • Oxford Brookes University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise Programme

Hand writing programme

Arm Description

6 months 2 x a week aerobic and anaerobic exercise delivered in community facilities by an exercise professional and supported by a physiotherapist.

6 months 2 x a week hand writing practice. Performed in the home supported by a physiotherapist (5 support sessions)

Outcomes

Primary Outcome Measures

Change in Two minute walk from baseline at 3 months
Distance covered in 2 minutes by walking at self selected speed
Change in Two minute walk from 3 months at 6 months
Distance covered in 2 minutes by walking at self selected speed
Change in Two minute walk from 6 months at 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
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 taken to place 9 pegs in 9 holes and remove them
Change in SF-36 from baseline at 3 months
General Health status questionnaire
Change in EQ-5D from baseline at 3 months
Quality of life questionnaire
Change in Prescribed medication from baseline at 3 months
Prescribed medication regime
Change in Blood Pressure from baseline at 3 months
Systolic and diastolic non-invasive blood pressure
Change in Body Mass Index from baseline at 3 months
Weight (kg)/ Height (m) ^2
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
Change in Leg power from baseline at 3 months
Leg power measured on the Nottingham leg power rig
Change in Grip Strength from baseline at 3 months
Grip strength measured by a dynamometer
Change in Disease Status from baseline at 3 months
Disease Status measured by Unified Parkinson's Disease Rating Scale
Change in Non-motor symptoms from baseline at 3 months
measured by the Non motor symptoms questionnaire
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
Change measured physical activity from baseline at 3 months
Activity measured by an ankle worn accelerometer (steps and step intensity) over seven days
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.
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)
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
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
Change in Nine hole peg test from 3 months at 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
Time taken to place 9 pegs in 9 holes and remove them
Change in SF-36 from 6 months at 12 months
General Health status questionnaire
Change in SF-36 from 3 months at 6 months
General Health status questionnaire
Change in EQ-5D from 3 months at 6 months
Quality of life questionnaire
Change in EQ-5D from 6 months at 12 months
Quality of life questionnaire
Change in Prescribed medication from 3 months at 6 months
Prescribed medication regime
Change in Prescribed medication from 6 months at 12 months
Prescribed medication regime
Change in Blood Pressure from 3 months at 6 months
Systolic and diastolic non-invasive blood pressure
Change in Blood Pressure from 6 months at 12 months
Systolic and diastolic non-invasive blood pressure
Change in Body Mass Index from 6 months at 12 months
Weight (kg)/ Height (m) ^2
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
Change in Leg power from 3 months at 6 months
Leg power measured on the Nottingham leg power rig
Change in Leg power from 6 months at 12 months
Leg power measured on the Nottingham leg power rig
Change in Grip Strength from 3 months at 6 months
Grip strength measured by a dynamometer
Change in Grip Strength from 6 months at 12 months
Grip strength measured by a dynamometer
Change in Disease Status from 3 months at 6 months
Disease Status measured by Unified Parkinson's Disease Rating Scale
Change in Disease Status from 6 months at 12 months
Disease Status measured by Unified Parkinson's Disease Rating Scale
Change in Non-motor symptoms from 3 months at 6 months
measured by the Non motor symptoms questionnaire
Change in Non-motor symptoms from 6 months at 12 months
measured by the Non motor symptoms questionnaire
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
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
Change measured physical activity from 3 months at 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
Activity measured by an ankle worn accelerometer (steps and step intensity) over seven days
Change in FSS from baseline at 3 months
Fatigue measured using the FSS (Fatigue Severity Scale)
Change in FSS from 3 months at 6 months
Fatigue measured using the FSS (Fatigue Severity Scale)
Change in FSS from 6 months at 12 months
Fatigue measured using the FSS (Fatigue Severity Scale)
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
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
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

Full Information

First Posted
September 15, 2011
Last Updated
October 20, 2014
Sponsor
Oxford Brookes University
Collaborators
National Institute for Health Research, United Kingdom, Royal Berkshire NHS Foundation Trust (participant identification centre), Nuffield Orthopaedic Centre NHS Trust (participant identification centre)
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1. Study Identification

Unique Protocol Identification Number
NCT01439022
Brief Title
Exercise Interventions in Parkinson's Disease
Official Title
Longer-term Exercise Interventions in People With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oxford Brookes University
Collaborators
National Institute for Health Research, United Kingdom, Royal Berkshire NHS Foundation Trust (participant identification centre), Nuffield Orthopaedic Centre NHS Trust (participant identification centre)

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's Disease, Exercise, Treatment Outcome, Patient Adherence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise Programme
Arm Type
Experimental
Arm Description
6 months 2 x a week aerobic and anaerobic exercise delivered in community facilities by an exercise professional and supported by a physiotherapist.
Arm Title
Hand writing programme
Arm Type
Active Comparator
Arm Description
6 months 2 x a week hand writing practice. Performed in the home supported by a physiotherapist (5 support sessions)
Intervention Type
Behavioral
Intervention Name(s)
Exercise Programme
Intervention Description
6 months 2 x a week aerobic and anaerobic exercise delivered in community facilities by an exercise professional and supported by a physiotherapist
Intervention Type
Behavioral
Intervention Name(s)
Hand Writing programme
Intervention Description
6 months 2 x a week hand writing practice. Performed in the home supported by a physiotherapist (5 support sessions)
Primary Outcome Measure Information:
Title
Change in Two minute walk from baseline at 3 months
Description
Distance covered in 2 minutes by walking at self selected speed
Time Frame
baseline and 3 months
Title
Change in Two minute walk from 3 months at 6 months
Description
Distance covered in 2 minutes by walking at self selected speed
Time Frame
3 months and 6 months
Title
Change in Two minute walk from 6 months at 12 months
Description
Distance covered in 2 minutes by walking at self selected speed
Time Frame
6 months and 12 months
Secondary Outcome Measure Information:
Title
Change in Time Up and Go (TUG) from baseline at 3 months
Description
Time taken to sit to stand from a chair , walk 3 meters, turn and return to sitting in the chair. At normal speed
Time Frame
baseline and 3 months
Title
Change in Nine hole peg test from baseline at 3 months
Description
Time taken to place 9 pegs in 9 holes and remove them
Time Frame
baseline and 3 months
Title
Change in SF-36 from baseline at 3 months
Description
General Health status questionnaire
Time Frame
baseline and 3 months
Title
Change in EQ-5D from baseline at 3 months
Description
Quality of life questionnaire
Time Frame
Baseline and 3 months
Title
Change in Prescribed medication from baseline at 3 months
Description
Prescribed medication regime
Time Frame
baseline and 3 months
Title
Change in Blood Pressure from baseline at 3 months
Description
Systolic and diastolic non-invasive blood pressure
Time Frame
baseline and 3 months
Title
Change in Body Mass Index from baseline at 3 months
Description
Weight (kg)/ Height (m) ^2
Time Frame
baseline and 3 months
Title
Change in aerobic fitness from baseline at 3 months
Description
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
Time Frame
baseline and 3 months
Title
Change in Leg power from baseline at 3 months
Description
Leg power measured on the Nottingham leg power rig
Time Frame
baseline and 3 months
Title
Change in Grip Strength from baseline at 3 months
Description
Grip strength measured by a dynamometer
Time Frame
baseline and 3 months
Title
Change in Disease Status from baseline at 3 months
Description
Disease Status measured by Unified Parkinson's Disease Rating Scale
Time Frame
baseline and 3 months
Title
Change in Non-motor symptoms from baseline at 3 months
Description
measured by the Non motor symptoms questionnaire
Time Frame
baseline and 3 months
Title
change in reported Physical Activity from baseline at 3 months
Description
Self reported retrospective physical activity in social, work and home domains. Measured by the Physical Activity Scale for the Elderly questionnaire
Time Frame
baseline and 3 months
Title
Change measured physical activity from baseline at 3 months
Description
Activity measured by an ankle worn accelerometer (steps and step intensity) over seven days
Time Frame
baseline and 3 months
Title
Process Evaluation
Description
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.
Time Frame
6 months (end intervention)
Title
Adherence
Description
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)
Time Frame
Particpants will be followed at each scheduled session for the duration of the intervention (6 months 2 x a week)
Title
Change in Time Up and Go (TUG) from 3 months at 6 months
Description
Time taken to sit to stand from a chair , walk 3 meters, turn and return to sitting in the chair. At normal speed
Time Frame
3 months and 6 months
Title
Change in Time Up and Go (TUG) from 6 months at 12 months
Description
Time taken to sit to stand from a chair , walk 3 meters, turn and return to sitting in the chair. At normal speed
Time Frame
6 months and 12 months
Title
Change in Nine hole peg test from 3 months at 6 months
Description
Time taken to place 9 pegs in 9 holes and remove them
Time Frame
3 months and 6 months
Title
Change in Nine hole peg test from 6 months at 12 months
Description
Time taken to place 9 pegs in 9 holes and remove them
Time Frame
6 months and 12 months
Title
Change in SF-36 from 6 months at 12 months
Description
General Health status questionnaire
Time Frame
6 months and 12 months
Title
Change in SF-36 from 3 months at 6 months
Description
General Health status questionnaire
Time Frame
3 months and 6 months
Title
Change in EQ-5D from 3 months at 6 months
Description
Quality of life questionnaire
Time Frame
3 months and 6 months
Title
Change in EQ-5D from 6 months at 12 months
Description
Quality of life questionnaire
Time Frame
6 months and 12 months
Title
Change in Prescribed medication from 3 months at 6 months
Description
Prescribed medication regime
Time Frame
3 months and 6 months
Title
Change in Prescribed medication from 6 months at 12 months
Description
Prescribed medication regime
Time Frame
6 months and 12 months
Title
Change in Blood Pressure from 3 months at 6 months
Description
Systolic and diastolic non-invasive blood pressure
Time Frame
3 months and 6 months
Title
Change in Blood Pressure from 6 months at 12 months
Description
Systolic and diastolic non-invasive blood pressure
Time Frame
6 months and 12 months
Title
Change in Body Mass Index from 6 months at 12 months
Description
Weight (kg)/ Height (m) ^2
Time Frame
6 months and 12 months
Title
Change in aerobic fitness from 6 months at 12 months
Description
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
Time Frame
6 months and 12 months
Title
Change in Leg power from 3 months at 6 months
Description
Leg power measured on the Nottingham leg power rig
Time Frame
3 months and 6 months
Title
Change in Leg power from 6 months at 12 months
Description
Leg power measured on the Nottingham leg power rig
Time Frame
6 months and 12 months
Title
Change in Grip Strength from 3 months at 6 months
Description
Grip strength measured by a dynamometer
Time Frame
3 months and 6 months
Title
Change in Grip Strength from 6 months at 12 months
Description
Grip strength measured by a dynamometer
Time Frame
6 months and 12 months
Title
Change in Disease Status from 3 months at 6 months
Description
Disease Status measured by Unified Parkinson's Disease Rating Scale
Time Frame
3 months and 6 months
Title
Change in Disease Status from 6 months at 12 months
Description
Disease Status measured by Unified Parkinson's Disease Rating Scale
Time Frame
6 months and 12 months
Title
Change in Non-motor symptoms from 3 months at 6 months
Description
measured by the Non motor symptoms questionnaire
Time Frame
3 months and 6 months
Title
Change in Non-motor symptoms from 6 months at 12 months
Description
measured by the Non motor symptoms questionnaire
Time Frame
6 months and 12 months
Title
Change in reported Physical Activity from 3 months at 6 months
Description
Self reported retrospective physical activity in social, work and home domains. Measured by the Physical Activity Scale for the Elderly questionnaire
Time Frame
3 months and 6 months
Title
Change in reported Physical Activity from 6 months at 12 months
Description
Self reported retrospective physical activity in social, work and home domains. Measured by the Physical Activity Scale for the Elderly questionnaire
Time Frame
6 months and 12 months
Title
Change measured physical activity from 3 months at 6 months
Description
Activity measured by an ankle worn accelerometer (steps and step intensity) over seven days
Time Frame
3 months and 6 months
Title
Change measured physical activity from 6 months at 12 months
Description
Activity measured by an ankle worn accelerometer (steps and step intensity) over seven days
Time Frame
6 months and 12 months
Title
Change in FSS from baseline at 3 months
Description
Fatigue measured using the FSS (Fatigue Severity Scale)
Time Frame
baseline and 3 months
Title
Change in FSS from 3 months at 6 months
Description
Fatigue measured using the FSS (Fatigue Severity Scale)
Time Frame
3 months and 6 months
Title
Change in FSS from 6 months at 12 months
Description
Fatigue measured using the FSS (Fatigue Severity Scale)
Time Frame
6 months and 12 months
Title
Change upper limb function from baseline at 3 months
Description
upper limb function of movement time, reaction time and movement error using a touch scene PC
Time Frame
baseline and 3 months
Title
Change upper limb function from 3 months at 6 months
Description
upper limb function of movement time, reaction time and movement error using a touch scene PC
Time Frame
3 months and 6 months
Title
Change upper limb function from 6 months at 12 months
Description
upper limb function of movement time, reaction time and movement error using a touch scene PC
Time Frame
6 months and12months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Dawes, PhD
Organizational Affiliation
Oxford Brookes University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oxford Brookes University
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 0SB
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
27837101
Citation
Collett J, Franssen M, Meaney A, Wade D, Izadi H, Tims M, Winward C, Bogdanovic M, Farmer A, Dawes H. Phase II randomised controlled trial of a 6-month self-managed community exercise programme for people with Parkinson's disease. J Neurol Neurosurg Psychiatry. 2017 Mar;88(3):204-211. doi: 10.1136/jnnp-2016-314508. Epub 2016 Nov 11.
Results Reference
derived

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Exercise Interventions in Parkinson's Disease

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