Exercise Interventions in Parkinson's Disease

Oxford Brookes University105 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

105

Conditions

Parkinson's Disease

Interventions

Exercise ProgrammeBEHAVIORAL

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 programmeBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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;

Locations (1)

Oxford Brookes University

Oxford, Oxfordshire, United Kingdom

Outcomes

Primary Outcomes

Change in Two minute walk from baseline at 3 months

Distance covered in 2 minutes by walking at self selected speed

Time frame: baseline and 3 months

Change in Two minute walk from 3 months at 6 months

Distance covered in 2 minutes by walking at self selected speed

Time frame: 3 months and 6 months

Change in Two minute walk from 6 months at 12 months

Distance covered in 2 minutes by walking at self selected speed

Time frame: 6 months and 12 months

Secondary Outcomes

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

Time frame: baseline and 3 months

Change in Nine hole peg test from baseline at 3 months

Time taken to place 9 pegs in 9 holes and remove them

Time frame: baseline and 3 months

Change in SF-36 from baseline at 3 months

General Health status questionnaire

Time frame: baseline and 3 months

Change in EQ-5D from baseline at 3 months

Quality of life questionnaire

Time frame: Baseline and 3 months

Change in Prescribed medication from baseline at 3 months

Prescribed medication regime

Data from ClinicalTrials.gov

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Time frame: baseline and 3 months

Change in Blood Pressure from baseline at 3 months

Systolic and diastolic non-invasive blood pressure

Time frame: baseline and 3 months

Change in Body Mass Index from baseline at 3 months

Weight (kg)/ Height (m) \^2

Time frame: baseline and 3 months

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

Time frame: baseline and 3 months

Change in Leg power from baseline at 3 months

Leg power measured on the Nottingham leg power rig

Time frame: baseline and 3 months

Change in Grip Strength from baseline at 3 months

Grip strength measured by a dynamometer

Time frame: baseline and 3 months

Change in Disease Status from baseline at 3 months

Disease Status measured by Unified Parkinson's Disease Rating Scale

Time frame: baseline and 3 months

Change in Non-motor symptoms from baseline at 3 months

measured by the Non motor symptoms questionnaire

Time frame: baseline and 3 months

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

Time frame: baseline and 3 months

Change measured physical activity from baseline at 3 months

Activity measured by an ankle worn accelerometer (steps and step intensity) over seven days

Time frame: baseline and 3 months

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.

Time frame: 6 months (end intervention)

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)

Time frame: Particpants will be followed at each scheduled session for the duration of the intervention (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

Time frame: 3 months and 6 months

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

Time frame: 6 months and 12 months

Change in Nine hole peg test from 3 months at 6 months

Time taken to place 9 pegs in 9 holes and remove them

Time frame: 3 months and 6 months

Change in Nine hole peg test from 6 months at 12 months

Time taken to place 9 pegs in 9 holes and remove them

Time frame: 6 months and 12 months

Change in SF-36 from 6 months at 12 months

General Health status questionnaire

Time frame: 6 months and 12 months

Change in SF-36 from 3 months at 6 months

General Health status questionnaire

Time frame: 3 months and 6 months

Change in EQ-5D from 3 months at 6 months

Quality of life questionnaire

Time frame: 3 months and 6 months

Change in EQ-5D from 6 months at 12 months

Quality of life questionnaire

Time frame: 6 months and 12 months

Change in Prescribed medication from 3 months at 6 months

Prescribed medication regime

Time frame: 3 months and 6 months

Change in Prescribed medication from 6 months at 12 months

Prescribed medication regime

Time frame: 6 months and 12 months

Change in Blood Pressure from 3 months at 6 months

Systolic and diastolic non-invasive blood pressure

Time frame: 3 months and 6 months

Change in Blood Pressure from 6 months at 12 months

Systolic and diastolic non-invasive blood pressure

Time frame: 6 months and 12 months

Change in Body Mass Index from 6 months at 12 months

Weight (kg)/ Height (m) \^2

Time frame: 6 months and 12 months

Change in aerobic fitness from 6 months at 12 months

Time frame: 6 months and 12 months

Change in Leg power from 3 months at 6 months

Leg power measured on the Nottingham leg power rig

Time frame: 3 months and 6 months

Change in Leg power from 6 months at 12 months

Leg power measured on the Nottingham leg power rig

Time frame: 6 months and 12 months

Change in Grip Strength from 3 months at 6 months

Grip strength measured by a dynamometer

Time frame: 3 months and 6 months

Change in Grip Strength from 6 months at 12 months

Grip strength measured by a dynamometer

Time frame: 6 months and 12 months

Change in Disease Status from 3 months at 6 months

Disease Status measured by Unified Parkinson's Disease Rating Scale

Time frame: 3 months and 6 months

Change in Disease Status from 6 months at 12 months

Disease Status measured by Unified Parkinson's Disease Rating Scale

Time frame: 6 months and 12 months

Change in Non-motor symptoms from 3 months at 6 months

measured by the Non motor symptoms questionnaire

Time frame: 3 months and 6 months

Change in Non-motor symptoms from 6 months at 12 months

measured by the Non motor symptoms questionnaire

Time frame: 6 months and 12 months

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

Time frame: 3 months and 6 months

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

Time frame: 6 months and 12 months

Change measured physical activity from 3 months at 6 months

Activity measured by an ankle worn accelerometer (steps and step intensity) over seven days

Time frame: 3 months and 6 months

Change measured physical activity from 6 months at 12 months

Activity measured by an ankle worn accelerometer (steps and step intensity) over seven days

Time frame: 6 months and 12 months

Change in FSS from baseline at 3 months

Fatigue measured using the FSS (Fatigue Severity Scale)

Time frame: baseline and 3 months

Change in FSS from 3 months at 6 months

Fatigue measured using the FSS (Fatigue Severity Scale)

Time frame: 3 months and 6 months

Change in FSS from 6 months at 12 months

Fatigue measured using the FSS (Fatigue Severity Scale)

Time frame: 6 months and 12 months

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

Time frame: baseline and 3 months

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

Time frame: 3 months and 6 months

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

Time frame: 6 months and12months