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Parkinson's DiseasePhase 2NCT01439022

Exercise Interventions in Parkinson's Disease

A Phase 2 study testing Exercise Programme and Hand Writing programme in people with Parkinson's Disease, run by Oxford Brookes University at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Parkinson's Disease
What is being tested?
Exercise Programme and Hand Writing programme
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
1 siteUnited Kingdom
Study dates
Sep 2011to Sep 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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;

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Oxford Brookes University

    Oxford, Oxfordshire, OX3 0SB

Other trials in United Kingdom

About this study

Official title: Longer-term Exercise Interventions in People With 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.

Read the 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.
Being tested
Exercise Programme, Hand Writing programme
Keywords
Parkinson's Disease, Exercise, Treatment Outcome, Patient Adherence
Medical subject headings
Parkinson Disease, Motor Activity, Patient Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise ProgrammeBehavioural

    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 programmeBehavioural

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

Study groups in NCT01439022
Study groupRoleWhat they receive
Exercise ProgrammeExperimental6 months 2 x a week aerobic and anaerobic exercise delivered in community facilities by an exercise professional and supported by a physiotherapist.
Receives: Behavioral: Exercise Programme
Hand writing programmeActive comparator6 months 2 x a week hand writing practice. Performed in the home supported by a physiotherapist (5 support sessions)
Receives: Behavioral: Hand Writing programme

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Distance covered in 2 minutes by walking at self selected speed

    Measured: baseline and 3 months

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

    Distance covered in 2 minutes by walking at self selected speed

    Measured: 3 months and 6 months

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

    Distance covered in 2 minutes by walking at self selected speed

    Measured: 6 months and 12 months

Secondary outcomes (48)

  1. 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

    Measured: baseline and 3 months

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

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

    Measured: baseline and 3 months

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

    General Health status questionnaire

    Measured: baseline and 3 months

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

    Quality of life questionnaire

    Measured: Baseline and 3 months

  5. Change in Prescribed medication from baseline at 3 months

    Prescribed medication regime

    Measured: baseline and 3 months

  6. Change in Blood Pressure from baseline at 3 months

    Systolic and diastolic non-invasive blood pressure

    Measured: baseline and 3 months

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

    Weight (kg)/ Height (m) ^2

    Measured: baseline and 3 months

  8. 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

    Measured: baseline and 3 months

  9. Change in Leg power from baseline at 3 months

    Leg power measured on the Nottingham leg power rig

    Measured: baseline and 3 months

  10. Change in Grip Strength from baseline at 3 months

    Grip strength measured by a dynamometer

    Measured: baseline and 3 months

  11. Change in Disease Status from baseline at 3 months

    Disease Status measured by Unified Parkinson's Disease Rating Scale

    Measured: baseline and 3 months

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

    measured by the Non motor symptoms questionnaire

    Measured: baseline and 3 months

  13. 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

    Measured: baseline and 3 months

  14. Change measured physical activity from baseline at 3 months

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

    Measured: baseline and 3 months

  15. 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.

    Measured: 6 months (end intervention)

  16. 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)

    Measured: Particpants will be followed at each scheduled session for the duration of the intervention (6 months 2 x a week)

  17. 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

    Measured: 3 months and 6 months

  18. 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

    Measured: 6 months and 12 months

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

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

    Measured: 3 months and 6 months

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

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

    Measured: 6 months and 12 months

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

    General Health status questionnaire

    Measured: 6 months and 12 months

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

    General Health status questionnaire

    Measured: 3 months and 6 months

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

    Quality of life questionnaire

    Measured: 3 months and 6 months

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

    Quality of life questionnaire

    Measured: 6 months and 12 months

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

    Prescribed medication regime

    Measured: 3 months and 6 months

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

    Prescribed medication regime

    Measured: 6 months and 12 months

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

    Systolic and diastolic non-invasive blood pressure

    Measured: 3 months and 6 months

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

    Systolic and diastolic non-invasive blood pressure

    Measured: 6 months and 12 months

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

    Weight (kg)/ Height (m) ^2

    Measured: 6 months and 12 months

  30. 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

    Measured: 6 months and 12 months

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

    Leg power measured on the Nottingham leg power rig

    Measured: 3 months and 6 months

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

    Leg power measured on the Nottingham leg power rig

    Measured: 6 months and 12 months

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

    Grip strength measured by a dynamometer

    Measured: 3 months and 6 months

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

    Grip strength measured by a dynamometer

    Measured: 6 months and 12 months

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

    Disease Status measured by Unified Parkinson's Disease Rating Scale

    Measured: 3 months and 6 months

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

    Disease Status measured by Unified Parkinson's Disease Rating Scale

    Measured: 6 months and 12 months

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

    measured by the Non motor symptoms questionnaire

    Measured: 3 months and 6 months

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

    measured by the Non motor symptoms questionnaire

    Measured: 6 months and 12 months

  39. 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

    Measured: 3 months and 6 months

  40. 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

    Measured: 6 months and 12 months

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

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

    Measured: 3 months and 6 months

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

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

    Measured: 6 months and 12 months

  43. Change in FSS from baseline at 3 months

    Fatigue measured using the FSS (Fatigue Severity Scale)

    Measured: baseline and 3 months

  44. Change in FSS from 3 months at 6 months

    Fatigue measured using the FSS (Fatigue Severity Scale)

    Measured: 3 months and 6 months

  45. Change in FSS from 6 months at 12 months

    Fatigue measured using the FSS (Fatigue Severity Scale)

    Measured: 6 months and 12 months

  46. 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

    Measured: baseline and 3 months

  47. 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

    Measured: 3 months and 6 months

  48. 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

    Measured: 6 months and12months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionSep 2014
  4. Study completionSep 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01439022
Sponsor's protocol ID
MSG_EXPD_11/SC/0267
Status last verified
Oct 2014
First submitted
15 Sep 2011
Last updated
21 Oct 2014
Results posted
No
Data monitoring committee
No

Publications

  • Moraes IAP, Collett J, Silva TDD, Franssen M, Mitta S, Zalewski P, Meaney A, Wade D, Izadi H, Winward C, Monteiro CBM, Dawes H. Sensorimotor functioning changes in response to global exercise versus handwriting upper limb exercise training in Parkinson's disease, results from a phase II randomised controlled trial. PLoS One. 2024 Aug 29;19(8):e0309217. doi: 10.1371/journal.pone.0309217. eCollection 2024.

    PubMed 39208136

  • Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

    PubMed 38588457

  • Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

    PubMed 36602886

  • 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.

    PubMed 27837101

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Exercise Programme and Hand Writing programme in people with Parkinson's Disease, run by Oxford Brookes University at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Two minute walk from baseline at 3 months (time frame: baseline and 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01439022, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2014.

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