Clinical trial NCT01439022: Exercise Interventions in Parkinson's Disease
Official title: Longer-term Exercise Interventions in People With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease
Exercise
Treatment Outcome
Patient Adherence
Lead sponsor: Oxford Brookes University
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
name: Royal Berkshire NHS Foundation Trust (participant identification centre)
name: Nuffield Orthopaedic Centre NHS Trust (participant identification centre)
First posted: 2011-09-22
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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;

Primary outcomes:
measure: Change in Two minute walk from baseline at 3 months
timeFrame: baseline and 3 months
measure: Change in Two minute walk from 3 months at 6 months
timeFrame: 3 months and 6 months
measure: Change in Two minute walk from 6 months at 12 months
timeFrame: 6 months and 12 months
Secondary outcomes:
measure: Change in Time Up and Go (TUG) from baseline at 3 months
timeFrame: baseline and 3 months
measure: Change in Nine hole peg test from baseline at 3 months
timeFrame: baseline and 3 months
measure: Change in SF-36 from baseline at 3 months
timeFrame: baseline and 3 months
measure: Change in EQ-5D from baseline at 3 months
timeFrame: Baseline and 3 months
measure: Change in Prescribed medication from baseline at 3 months
timeFrame: baseline and 3 months
measure: Change in Blood Pressure from baseline at 3 months
timeFrame: baseline and 3 months
measure: Change in Body Mass Index from baseline at 3 months
timeFrame: baseline and 3 months
measure: Change in aerobic fitness from baseline at 3 months
timeFrame: baseline and 3 months
measure: Change in Leg power from baseline at 3 months
timeFrame: baseline and 3 months
measure: Change in Grip Strength from baseline at 3 months
timeFrame: baseline and 3 months
measure: Change in Disease Status from baseline at 3 months
timeFrame: baseline and 3 months
measure: Change in Non-motor symptoms from baseline at 3 months
timeFrame: baseline and 3 months
measure: change in reported Physical Activity from baseline at 3 months
timeFrame: baseline and 3 months
measure: Change measured physical activity from baseline at 3 months
timeFrame: baseline and 3 months
measure: Process Evaluation
timeFrame: 6 months (end intervention)
measure: Adherence
timeFrame: Particpants will be followed at each scheduled session for the duration of the intervention (6 months 2 x a week)
measure: Change in Time Up and Go (TUG) from 3 months at 6 months
timeFrame: 3 months and 6 months
measure: Change in Time Up and Go (TUG) from 6 months at 12 months
timeFrame: 6 months and 12 months
measure: Change in Nine hole peg test from 3 months at 6 months
timeFrame: 3 months and 6 months
measure: Change in Nine hole peg test from 6 months at 12 months
timeFrame: 6 months and 12 months
measure: Change in SF-36 from 6 months at 12 months
timeFrame: 6 months and 12 months
measure: Change in SF-36 from 3 months at 6 months
timeFrame: 3 months and 6 months
measure: Change in EQ-5D from 3 months at 6 months
timeFrame: 3 months and 6 months
measure: Change in EQ-5D from 6 months at 12 months
timeFrame: 6 months and 12 months
measure: Change in Prescribed medication from 3 months at 6 months
timeFrame: 3 months and 6 months
measure: Change in Prescribed medication from 6 months at 12 months
timeFrame: 6 months and 12 months
measure: Change in Blood Pressure from 3 months at 6 months
timeFrame: 3 months and 6 months
measure: Change in Blood Pressure from 6 months at 12 months
timeFrame: 6 months and 12 months
measure: Change in Body Mass Index from 6 months at 12 months
timeFrame: 6 months and 12 months
measure: Change in aerobic fitness from 6 months at 12 months
timeFrame: 6 months and 12 months
measure: Change in Leg power from 3 months at 6 months
timeFrame: 3 months and 6 months
measure: Change in Leg power from 6 months at 12 months
timeFrame: 6 months and 12 months
measure: Change in Grip Strength from 3 months at 6 months
timeFrame: 3 months and 6 months
measure: Change in Grip Strength from 6 months at 12 months
timeFrame: 6 months and 12 months
measure: Change in Disease Status from 3 months at 6 months
timeFrame: 3 months and 6 months
measure: Change in Disease Status from 6 months at 12 months
timeFrame: 6 months and 12 months
measure: Change in Non-motor symptoms from 3 months at 6 months
timeFrame: 3 months and 6 months
measure: Change in Non-motor symptoms from 6 months at 12 months
timeFrame: 6 months and 12 months
measure: Change in reported Physical Activity from 3 months at 6 months
timeFrame: 3 months and 6 months
measure: Change in reported Physical Activity from 6 months at 12 months
timeFrame: 6 months and 12 months
measure: Change measured physical activity from 3 months at 6 months
timeFrame: 3 months and 6 months
measure: Change measured physical activity from 6 months at 12 months
timeFrame: 6 months and 12 months
measure: Change in FSS from baseline at 3 months
timeFrame: baseline and 3 months
measure: Change in FSS from 3 months at 6 months
timeFrame: 3 months and 6 months
measure: Change in FSS from 6 months at 12 months
timeFrame: 6 months and 12 months
measure: Change upper limb function from baseline at 3 months
timeFrame: baseline and 3 months
measure: Change upper limb function from 3 months at 6 months
timeFrame: 3 months and 6 months
measure: Change upper limb function from 6 months at 12 months
timeFrame: 6 months and12months
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Oxford Brookes University
state: Oxfordshire
Study officials:
affiliation: Oxford Brookes University
name: Helen Dawes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.