Exercise Interventions in Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01439022
• Other study ID #: MSG_EXPD_11/SC/0267
• Status: Completed
• Phase: Phase 2
• First received: September 15, 2011
• Last updated: October 20, 2014
• Start date: September 2011
• Est. completion date: September 2014

Study information

• Verified date: October 2014
• Source: Oxford Brookes University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Institute for Health ResearchUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Behavioral:
• 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
• Hand Writing programme
6 months 2 x a week hand writing practice. Performed in the home supported by a physiotherapist (5 support sessions)

Locations

Country	Name	City	State
United Kingdom	Oxford Brookes University	Oxford	Oxfordshire

Sponsors (4)

Lead Sponsor	Collaborator
Oxford Brookes University	National Institute for Health Research, United Kingdom, Nuffield Orthopaedic Centre NHS Trust (participant identification centre), Royal Berkshire NHS Foundation Trust (participant identification centre)

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Two minute walk from baseline at 3 months	Distance covered in 2 minutes by walking at self selected speed	baseline and 3 months	No
Primary	Change in Two minute walk from 3 months at 6 months	Distance covered in 2 minutes by walking at self selected speed	3 months and 6 months	No
Primary	Change in Two minute walk from 6 months at 12 months	Distance covered in 2 minutes by walking at self selected speed	6 months and 12 months	No
Secondary	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	baseline and 3 months	No
Secondary	Change in Nine hole peg test from baseline at 3 months	Time taken to place 9 pegs in 9 holes and remove them	baseline and 3 months	No
Secondary	Change in SF-36 from baseline at 3 months	General Health status questionnaire	baseline and 3 months	No
Secondary	Change in EQ-5D from baseline at 3 months	Quality of life questionnaire	Baseline and 3 months	No
Secondary	Change in Prescribed medication from baseline at 3 months	Prescribed medication regime	baseline and 3 months	No
Secondary	Change in Blood Pressure from baseline at 3 months	Systolic and diastolic non-invasive blood pressure	baseline and 3 months	No
Secondary	Change in Body Mass Index from baseline at 3 months	Weight (kg)/ Height (m) ^2	baseline and 3 months	No
Secondary	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	baseline and 3 months	No
Secondary	Change in Leg power from baseline at 3 months	Leg power measured on the Nottingham leg power rig	baseline and 3 months	No
Secondary	Change in Grip Strength from baseline at 3 months	Grip strength measured by a dynamometer	baseline and 3 months	No
Secondary	Change in Disease Status from baseline at 3 months	Disease Status measured by Unified Parkinson's Disease Rating Scale	baseline and 3 months	No
Secondary	Change in Non-motor symptoms from baseline at 3 months	measured by the Non motor symptoms questionnaire	baseline and 3 months	No
Secondary	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	baseline and 3 months	No
Secondary	Change measured physical activity from baseline at 3 months	Activity measured by an ankle worn accelerometer (steps and step intensity) over seven days	baseline and 3 months	No
Secondary	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.	6 months (end intervention)	No
Secondary	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)	Particpants will be followed at each scheduled session for the duration of the intervention (6 months 2 x a week)	No
Secondary	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	3 months and 6 months	No
Secondary	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	6 months and 12 months	No
Secondary	Change in Nine hole peg test from 3 months at 6 months	Time taken to place 9 pegs in 9 holes and remove them	3 months and 6 months	No
Secondary	Change in Nine hole peg test from 6 months at 12 months	Time taken to place 9 pegs in 9 holes and remove them	6 months and 12 months	No
Secondary	Change in SF-36 from 6 months at 12 months	General Health status questionnaire	6 months and 12 months	No
Secondary	Change in SF-36 from 3 months at 6 months	General Health status questionnaire	3 months and 6 months	No
Secondary	Change in EQ-5D from 3 months at 6 months	Quality of life questionnaire	3 months and 6 months	No
Secondary	Change in EQ-5D from 6 months at 12 months	Quality of life questionnaire	6 months and 12 months	No
Secondary	Change in Prescribed medication from 3 months at 6 months	Prescribed medication regime	3 months and 6 months	No
Secondary	Change in Prescribed medication from 6 months at 12 months	Prescribed medication regime	6 months and 12 months	No
Secondary	Change in Blood Pressure from 3 months at 6 months	Systolic and diastolic non-invasive blood pressure	3 months and 6 months	No
Secondary	Change in Blood Pressure from 6 months at 12 months	Systolic and diastolic non-invasive blood pressure	6 months and 12 months	No
Secondary	Change in Body Mass Index from 6 months at 12 months	Weight (kg)/ Height (m) ^2	6 months and 12 months	No
Secondary	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	6 months and 12 months	No
Secondary	Change in Leg power from 3 months at 6 months	Leg power measured on the Nottingham leg power rig	3 months and 6 months	No
Secondary	Change in Leg power from 6 months at 12 months	Leg power measured on the Nottingham leg power rig	6 months and 12 months	No
Secondary	Change in Grip Strength from 3 months at 6 months	Grip strength measured by a dynamometer	3 months and 6 months	No
Secondary	Change in Grip Strength from 6 months at 12 months	Grip strength measured by a dynamometer	6 months and 12 months	No
Secondary	Change in Disease Status from 3 months at 6 months	Disease Status measured by Unified Parkinson's Disease Rating Scale	3 months and 6 months	No
Secondary	Change in Disease Status from 6 months at 12 months	Disease Status measured by Unified Parkinson's Disease Rating Scale	6 months and 12 months	No
Secondary	Change in Non-motor symptoms from 3 months at 6 months	measured by the Non motor symptoms questionnaire	3 months and 6 months	No
Secondary	Change in Non-motor symptoms from 6 months at 12 months	measured by the Non motor symptoms questionnaire	6 months and 12 months	No
Secondary	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	3 months and 6 months	No
Secondary	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	6 months and 12 months	No
Secondary	Change measured physical activity from 3 months at 6 months	Activity measured by an ankle worn accelerometer (steps and step intensity) over seven days	3 months and 6 months	No
Secondary	Change measured physical activity from 6 months at 12 months	Activity measured by an ankle worn accelerometer (steps and step intensity) over seven days	6 months and 12 months	No
Secondary	Change in FSS from baseline at 3 months	Fatigue measured using the FSS (Fatigue Severity Scale)	baseline and 3 months	No
Secondary	Change in FSS from 3 months at 6 months	Fatigue measured using the FSS (Fatigue Severity Scale)	3 months and 6 months	No
Secondary	Change in FSS from 6 months at 12 months	Fatigue measured using the FSS (Fatigue Severity Scale)	6 months and 12 months	No
Secondary	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	baseline and 3 months	No
Secondary	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	3 months and 6 months	No
Secondary	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	6 months and12months	No

External Links

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