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Completed

NCT Number: NCT01439022

Exercise Interventions in Parkinson's Disease

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Behavior Brain Diseases Central Nervous System Diseases Health Behavior Motor Activity Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Patient Acceptance of Health Care Patient Compliance Synucleinopathies Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Oxford Brookes University

Oxford, Oxfordshire, OX3 0SB, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Exercise Programme

Behavioral

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 programme

Behavioral

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

Primary outcomes

  1. Change in Two minute walk from baseline at 3 months

    Time frame: baseline and 3 months

    Distance covered in 2 minutes by walking at self selected speed

  2. Change in Two minute walk from 3 months at 6 months

    Time frame: 3 months and 6 months

    Distance covered in 2 minutes by walking at self selected speed

  3. Change in Two minute walk from 6 months at 12 months

    Time frame: 6 months and 12 months

    Distance covered in 2 minutes by walking at self selected speed

Secondary outcomes

  1. Change in Time Up and Go (TUG) from baseline at 3 months

    Time frame: 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

  2. Change in Nine hole peg test from baseline at 3 months

    Time frame: baseline and 3 months

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

  3. Change in SF-36 from baseline at 3 months

    Time frame: baseline and 3 months

    General Health status questionnaire

  4. Change in EQ-5D from baseline at 3 months

    Time frame: Baseline and 3 months

    Quality of life questionnaire

  5. Change in Prescribed medication from baseline at 3 months

    Time frame: baseline and 3 months

    Prescribed medication regime

  6. Change in Blood Pressure from baseline at 3 months

    Time frame: baseline and 3 months

    Systolic and diastolic non-invasive blood pressure

  7. Change in Body Mass Index from baseline at 3 months

    Time frame: baseline and 3 months

    Weight (kg)/ Height (m) ^2

  8. Change in aerobic fitness from baseline at 3 months

    Time frame: 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

  9. Change in Leg power from baseline at 3 months

    Time frame: baseline and 3 months

    Leg power measured on the Nottingham leg power rig

  10. Change in Grip Strength from baseline at 3 months

    Time frame: baseline and 3 months

    Grip strength measured by a dynamometer

  11. Change in Disease Status from baseline at 3 months

    Time frame: baseline and 3 months

    Disease Status measured by Unified Parkinson's Disease Rating Scale

  12. Change in Non-motor symptoms from baseline at 3 months

    Time frame: baseline and 3 months

    measured by the Non motor symptoms questionnaire

  13. change in reported Physical Activity from baseline at 3 months

    Time frame: 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

  14. Change measured physical activity from baseline at 3 months

    Time frame: baseline and 3 months

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

  15. Process Evaluation

    Time frame: 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.

  16. Adherence

    Time frame: 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)

  17. Change in Time Up and Go (TUG) from 3 months at 6 months

    Time frame: 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

  18. Change in Time Up and Go (TUG) from 6 months at 12 months

    Time frame: 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

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

    Time frame: 3 months and 6 months

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

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

    Time frame: 6 months and 12 months

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

  21. Change in SF-36 from 6 months at 12 months

    Time frame: 6 months and 12 months

    General Health status questionnaire

  22. Change in SF-36 from 3 months at 6 months

    Time frame: 3 months and 6 months

    General Health status questionnaire

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

    Time frame: 3 months and 6 months

    Quality of life questionnaire

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

    Time frame: 6 months and 12 months

    Quality of life questionnaire

  25. Change in Prescribed medication from 3 months at 6 months

    Time frame: 3 months and 6 months

    Prescribed medication regime

  26. Change in Prescribed medication from 6 months at 12 months

    Time frame: 6 months and 12 months

    Prescribed medication regime

  27. Change in Blood Pressure from 3 months at 6 months

    Time frame: 3 months and 6 months

    Systolic and diastolic non-invasive blood pressure

  28. Change in Blood Pressure from 6 months at 12 months

    Time frame: 6 months and 12 months

    Systolic and diastolic non-invasive blood pressure

  29. Change in Body Mass Index from 6 months at 12 months

    Time frame: 6 months and 12 months

    Weight (kg)/ Height (m) ^2

  30. Change in aerobic fitness from 6 months at 12 months

    Time frame: 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

  31. Change in Leg power from 3 months at 6 months

    Time frame: 3 months and 6 months

    Leg power measured on the Nottingham leg power rig

  32. Change in Leg power from 6 months at 12 months

    Time frame: 6 months and 12 months

    Leg power measured on the Nottingham leg power rig

  33. Change in Grip Strength from 3 months at 6 months

    Time frame: 3 months and 6 months

    Grip strength measured by a dynamometer

  34. Change in Grip Strength from 6 months at 12 months

    Time frame: 6 months and 12 months

    Grip strength measured by a dynamometer

  35. Change in Disease Status from 3 months at 6 months

    Time frame: 3 months and 6 months

    Disease Status measured by Unified Parkinson's Disease Rating Scale

  36. Change in Disease Status from 6 months at 12 months

    Time frame: 6 months and 12 months

    Disease Status measured by Unified Parkinson's Disease Rating Scale

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

    Time frame: 3 months and 6 months

    measured by the Non motor symptoms questionnaire

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

    Time frame: 6 months and 12 months

    measured by the Non motor symptoms questionnaire

  39. Change in reported Physical Activity from 3 months at 6 months

    Time frame: 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

  40. Change in reported Physical Activity from 6 months at 12 months

    Time frame: 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

  41. Change measured physical activity from 3 months at 6 months

    Time frame: 3 months and 6 months

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

  42. Change measured physical activity from 6 months at 12 months

    Time frame: 6 months and 12 months

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

  43. Change in FSS from baseline at 3 months

    Time frame: baseline and 3 months

    Fatigue measured using the FSS (Fatigue Severity Scale)

  44. Change in FSS from 3 months at 6 months

    Time frame: 3 months and 6 months

    Fatigue measured using the FSS (Fatigue Severity Scale)

  45. Change in FSS from 6 months at 12 months

    Time frame: 6 months and 12 months

    Fatigue measured using the FSS (Fatigue Severity Scale)

  46. Change upper limb function from baseline at 3 months

    Time frame: baseline and 3 months

    upper limb function of movement time, reaction time and movement error using a touch scene PC

  47. Change upper limb function from 3 months at 6 months

    Time frame: 3 months and 6 months

    upper limb function of movement time, reaction time and movement error using a touch scene PC

  48. Change upper limb function from 6 months at 12 months

    Time frame: 6 months and12months

    upper limb function of movement time, reaction time and movement error using a touch scene PC

Sponsors and collaborators

Lead sponsor

Oxford Brookes University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Sep 22, 2011
Registry last updated
Oct 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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