Exercise Interventions in Parkinson's Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Institute for Health Research, United Kingdom
Royal Berkshire NHS Foundation Trust (participant identification centre)
Nuffield Orthopaedic Centre NHS Trust (participant identification centre)
Information provided by (Responsible Party):
Dr Johnny Collett, Oxford Brookes University
ClinicalTrials.gov Identifier:
NCT01439022
First received: September 15, 2011
Last updated: August 7, 2013
Last verified: August 2013
  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

Resource links provided by NLM:


Further study details as provided by Oxford Brookes University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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:

  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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01439022

Locations
United Kingdom
Oxford Brookes University
Oxford, Oxfordshire, United Kingdom, OX3 0SB
Sponsors and Collaborators
Oxford Brookes University
National Institute for Health Research, United Kingdom
Royal Berkshire NHS Foundation Trust (participant identification centre)
Nuffield Orthopaedic Centre NHS Trust (participant identification centre)
Investigators
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: August 7, 2013
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 July 22, 2014