Exercise Interventions in Parkinson's Disease

NCT ID: NCT01439022

Last Updated: 2014-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2014-09-30

Brief Summary

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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

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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.

Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Exercise Programme

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Hand Writing programme

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

Hand Writing programme

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role collaborator

Royal Berkshire NHS Foundation Trust (participant identification centre)

UNKNOWN

Sponsor Role collaborator

Nuffield Orthopaedic Centre NHS Trust (participant identification centre)

UNKNOWN

Sponsor Role collaborator

Oxford Brookes University

OTHER

Sponsor Role lead

Responsible Party

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Dr Johnny Collett

Research Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Helen Dawes, PhD

Role: PRINCIPAL_INVESTIGATOR

Oxford Brookes University

Locations

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Oxford Brookes University

Oxford, Oxfordshire, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 38588457 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36602886 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27837101 (View on PubMed)

Related Links

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Other Identifiers

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MSG_EXPD_11/SC/0267

Identifier Type: -

Identifier Source: org_study_id

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