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Exercise Interventions in Parkinson's Disease

O

Oxford Brookes University

Status and phase

Completed
Phase 2

Conditions

Parkinson's Disease

Treatments

Behavioral: Hand Writing programme
Behavioral: Exercise Programme

Study type

Interventional

Funder types

Other

Identifiers

NCT01439022
MSG_EXPD_11/SC/0267

Details and patient eligibility

About

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.

Full 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.

Enrollment

105 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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;

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

105 participants in 2 patient groups

Exercise Programme
Experimental group
Description:
6 months 2 x a week aerobic and anaerobic exercise delivered in community facilities by an exercise professional and supported by a physiotherapist.
Treatment:
Behavioral: Exercise Programme
Hand writing programme
Active Comparator group
Description:
6 months 2 x a week hand writing practice. Performed in the home supported by a physiotherapist (5 support sessions)
Treatment:
Behavioral: Hand Writing programme

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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