Is Physiotherapy Effective for People With Early Parkinson's (PEEP) a Feasibility Study
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 40
- Primary Endpoint
- Length of waiting time from enrolment to delivery of intervention.
Study Overview
Brief Summary
Parkinson's disease is a progressive neurodegenerative condition affecting 145,500 people in the UK. The condition impairs movement leading to gait and dexterity problems. Various types of exercise are beneficial for both motor and non-motor symptoms such as depression.
The World Health Organisation's (WHO) recommendations on exercise include at least 150 minutes of moderate-intensity aerobic physical activity per week . People with Parkinson's may struggle to achieve this because of movement problems and fatigue. Physiotherapists may have a role in persuading people to exercise and supporting them in their activity goals. While studies show that Parkinson's patients with falls or gait freezing clearly benefit form physiotherapy, there is at present no robust evidence to demonstrate the impact of physiotherapy early in the course of the illness.
PEEP seeks to explore the effectiveness of physiotherapy for early Parkinson's (ie within 4 years of diagnosis and before onset of falls).
It comprises three distinct parts:
- A survey of people with Parkinson's exploring their experience and opinions with respect to physiotherapy for early Parkinson's
- A feasibility randomised controlled trial (fRCT)
- A qualitative process evaluation. The fRCT will aim to recruit and randomise 40 people withParkinson's who have been diagnosed in the last 4 years and have had no physiotherapy. These participants will undergo several assessments at baseline, 3 months and 6 months, and will also have 7 days' worth of activity monitoring done via physical diary and a commercially available activity tracker to determine levels of activity. Participants randomised to the intervention arm will also receive 5 physiotherapy sessions (1 for assessment and 4 for treatment) additional to standard NHS care.
Staff and some participants involved in the fRCT will be included in a qualitative process evaluation to assess the acceptability and feasibility of the intervention and the research assessments.
Detailed Description
The Principle research question is:
- To explore the experience and opinions of people with Parkinson's in relation to physiotherapy and exercise in early disease.
- To develop a physiotherapy exercise intervention for people with early Parkinson's disease using insights from patients and professionals.
- To explore the feasibility of a future definitive randomised controlled trial, which would investigate the clinical and cost effectiveness of the physiotherapy intervention
The project has 3 elements:
- A survey of people with Parkinson's exploring their views about physiotherapy and exercise.
- A feasibility randomised trial of Parkinson's versus usual care for people with Parkinson's.
- A qualitative process evaluation exploring view of participants, research nurses and treating physiotherapists on the acceptability and of the intervention and the research assessments.
Survey of people with Parkinson's:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Survey of people with Parkinson's
- •People with Parkinson's aged >18, diagnosed within the last 4 years.
- •Able to read and write English.
- •Willing to take part in survey.
- •Feasibility RCT
- •Parkinson's disease diagnosed <4 years before study entry
- •Parkinson's diagnoses fits UK Brain Bank criteria
- •Age ≥18 years at study entry
- •Willingness to attend for physiotherapy interventions
- •Ability to transfer and walk independently
- •Stable Parkinson's medication:
- •Parkinson's medication not commenced or altered in last 2 months.
- •Changes to Parkinson's medication are not planned/scheduled in next 6 months
- •Participants not on PD medication can be recruited. (Treating clinicians can change Parkinson's medication during study according to clinical need and changes will be recorded on case report form.)
- •Qualitative process evaluation
- •Participants of the feasibility RCT
- •Physiotherapists within the trial conducting assessments and treatments.
- •Research Nurses who delivered the RCT
Exclusion Criteria
- •Hoehn-Yahr stage 4-5 (Hoehn -Yahr staging included as Appendix 2)
- •Lacks capacity to consent
- •Meets the criteria for commencement of the Gold Standards Framework (see Appendix 3)
- •Falls [more than 1 fall in the 3 months prior to enrolment]
- •Freezing of gait
- •Already had outpatient (OP) or community physiotherapy for Parkinson's:
- •OP physiotherapy for trauma or arthritis will not be exclusion A single one -off assessment of Parkinson's by a physiotherapist will not be an exclusion Attendance at exercise classes which are not supervised by a physiotherapist will not count as an exclusion.
- •IP physiotherapy will not count as an exclusion Unable to communicate in English
Arms & Interventions
Comparison
In this arm participants will attend 3 study visits to complete study questionnaire and assessments. In between these visits, participants will be asked to wear an activity monitor and record an activity diary for one week. Other than this, participants will continue to receive only standard of care treatment.
Intervention arm
In this arm participants will attend the same 3 study visits to complete study questionnaires and assessments. Participants will be asked to wear an acitvity monitor and record an activity diary for one week after the study visits. In between baseline and 6 month follow up, intervention arm participants will receive study physiotherapy. This will consist of an individual assessment and 4 additional sessions of physiotherapy.
Intervention: Physiotherapy Intervention (Other)
Outcomes
Primary Outcomes
Length of waiting time from enrolment to delivery of intervention.
Time Frame: Collected up to 130 weeks.
Measurement of time between consent and the completion of the physiotherapy intervention. This will be considered a feasibility outcome to determine whether the intervention is feasible for a larger definitive study.
Number of Eligible Patients
Time Frame: Collected up to 104 weeks.
Screening data will be collected to understand how many participants are eligible for the study. This data is a feasibility outcome which will be used to determine if a larger scale definitive study is possible. The data collected surrounding number of eligible patients can help to power in any future study.
Completeness of data collection for clinical outcomes.
Time Frame: Collected up to 130 weeks.
Percentage of data completeness will be collected as a feasibility outcome to determine if clinical outcomes can be used in a definitive study
Change from baseline to follow up time points for all clinical outcomes
Time Frame: Collected up to 130 weeks.
The change in all clinical outcomes from baseline to 6 months, the standard deviation, and the effect size of clinical outcomes to define the primary outcome for a future definitive trial.
Feasibility of Using Activity Monitor
Time Frame: Collected up to 130 weeks.
• Practicalities (including time taken to retrieve and record data) of using commercially available activity monitors as an outcome measure.
Feasibility and Acceptability of Study Intervention through Qualitative interviews with staff and Clinicians working on study.
Time Frame: Collect
Interviews will cover the following topics to assist in determining if a definitive future trial is feasible. * The different elements of usual care in two centres, including use of physiotherapy. * Time needed for research nurse to complete and record all study assessments and outcomes as assessed by qualitative interview. * Recruitment rate. Describe reasons patients chose not take part. * Feedback from the clinicians delivering the intervention about which elements of the intervention could be delivered in a large RCT, the optimal number of patient-therapist interactions and appropriateness of outcomes. * Delivery of the proposed intervention by the physiotherapy services at baseline assessment, follow up visits, telephone reviews.
Adherence of clinical staff to intervention protocol.
Time Frame: Collected up to 130 weeks
This outcome will assess whether the planned number of physiotherapy treatment sessions (4) and follow up telephone consultations (2) are undertaken. A bespoke checklist will be used to document each phone call and physiotherapy visit to outline that the intervention has been delivered.
Whether the person assessing the clinical outcomes at baseline, 3 month and 6 month outcomes is blinded
Time Frame: Collected up to 130 weeks.
This will be self reported by the clinician to indicate if the blind was broken. This will be used as a feasibility outcome to determine if any future definitive study can be blinded
Feasibility and Acceptability of Study Intervention through Qualitative interviews with participants who participated in the study.
Time Frame: Collected up to 130 weeks
Purpose of the interviews is to determine if a future definitive trial is feasible and acceptable for participants. Interviews will cover the following topics. * Patient adherence to visit and treatment schedule. Facilitators and barriers for attending the visits and undertaking the required treatment. * Feedback from the patients about the acceptability of the treatment programme and the study assessments.
Secondary Outcomes
- Activity Monitor Data(Collected up to 6 months.)
- Short Form 12 (SF12)(Collected at baseline, 3 and 6 month follow up visit)
- Unified Parkinson's Disease Rating Scale (UPDRS)(Collected at Baseline, 3 and 6 month follow up)
- Mini Balance Evaluation Systems Test (mini-BEST)(Collected at baseline, 3 and 6 month follow up visits)
- Tragus to Wall distance (posture assessment)(Collected at baseline, 3 and 6 month follow up visits)
- Activity(Collected up to 6 months.)
- Parkinson's Disease Questionnaire 39 (PDQ-39)(Collected at Baseline, 3 and 6 month follow up)
- Lindop Parkinson's Assessment Scale [LPAS](Collected at baseline, 3 and 6 month follow up visit)
- Number of Falls(Collected at baseline , 3 month and 6 month follow up visits.)