Clinical trial NCT04389138: Is Remote Physiotherapy Effective for People With Early Parkinson's (PEEP)
Official title: Is Physiotherapy Effective for People With Early Parkinson's (PEEP) a Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: University Hospitals of Derby and Burton NHS Foundation Trust
Sponsor class: OTHER
First posted: 2020-05-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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:

1. A survey of people with Parkinson's exploring their experience and opinions with respect to physiotherapy for early Parkinson's
2. A feasibility randomised controlled trial (fRCT)
3. 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:

1. A survey of people with Parkinson's exploring their views about physiotherapy and exercise.
2. A feasibility randomised trial of Parkinson's versus usual care for people with Parkinson's.
3. 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:

Online and paper survey will be available for people with Parkinson's to complete. The survey will be posted on the Parkinson's UK website. The survey will be open to UK residents with Parkinson's who have been diagnosed within the last 4 years.

Feasibility Randomised Controlled Trial The project will also consist of a Feasibility trial of physiotherapy for early Parkinson's versus usual care. Randomised controlled trial. Blinded assessment of outcomes. Parallel group design. Patient will be followed up at 3 and 6 months after the baseline visit. The RCT will be set in two NHS tertiary care centres.

At baseline, the following study procedures will be completed. Eligibity assessment by the PI or delegated research team member. 1. Demographics, medical history, medication history, physical examination (DOB, Height, Weight, Sex) The following Standard Questionnaires will be completed at the baseline visit.

* Montreal cognitive assessment (MoCA). This is a measure of cognition widely used in Parkinson's clinics (38).
* PDQ-39.
* UPDRS. This is a Parkinson's assessment tool that includes subsections looking at motor symptoms and signs, non-motor symptoms, activities of daily living and mood.
* SF-12. This is a measure of health related quality of life. Where the participant with Parkinson's has a carer who has agreed to take part in the study the investigator will ask the carer to complete this assessment.
* LPAS
* Mini-BEST
* Tragus to wall distance. Activity diaries: Participants will be given an activity diary and asked to record their activity over the next 7 days (starting the day after the initial visit). The activity diary will be returned to the research team in a pre-paid addressed envelope that will be provided to the participant.

Activity monitors: The research nurse will provide each participant with a activity monitor and provide instruction on how to use and charge at home. The monitor will be provided fully charged. The device will be worn on the wrist. Participants will be asked to wear the device for the next 7 days. The device can be worn while showering or swimming. The device should then be returned to the research team in a stamped addressed envelope provided, along with the completed activity diary. The main outcomes of interest from the activity monitors will be average daily step count and active minutes/day.

For Participants randomised to the intervention arm, they will attend an initial assessment visit followed by 4 physiotherapy intervention visits. At each of these 5 visits, a checklist will be completed by the physiotherapist to document what has been delivered as part of the intervention.

The following assessments will take place at 3 months and 6 months after baseline visit.

* Medication history.
* PDQ-39
* SF-12
* Number of falls
* 7 day activity diary
* Activity monitor (7days)
* LPAS
* Tragus to wall
* Record of outside of study therapy interventions.
* Adverse event register
* The outcome assessor will be asked if they have been unblinded.
* The mini-BEST will be measured at 3 months.

Qualitative Process evaluation.

Both staff and participants will be interviewed to explore views on care and the intervention. Interviews will last roughly 1 hour. Interviews will include:

* 6-10 physiotherapists
* 6-8 Participants from the Randomised controlled trial
* 2-4 Research Nurses from the Randomised controlled trial.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Eligible Patients
timeFrame: Collected up to 104 weeks.
measure: Length of waiting time from enrolment to delivery of intervention.
timeFrame: Collected up to 130 weeks.
measure: Change from baseline to follow up time points for all clinical outcomes
timeFrame: Collected up to 130 weeks.
measure: Completeness of data collection for clinical outcomes.
timeFrame: Collected up to 130 weeks.
measure: Adherence of clinical staff to intervention protocol.
timeFrame: Collected up to 130 weeks
measure: Whether the person assessing the clinical outcomes at baseline, 3 month and 6 month outcomes is blinded
timeFrame: Collected up to 130 weeks.
measure: Feasibility of Using Activity Monitor
timeFrame: Collected up to 130 weeks.
measure: Feasibility and Acceptability of Study Intervention through Qualitative interviews with staff and Clinicians working on study.
timeFrame: Collect
measure: Feasibility and Acceptability of Study Intervention through Qualitative interviews with participants who participated in the study.
timeFrame: Collected up to 130 weeks
Secondary outcomes:
measure: Parkinson's Disease Questionnaire 39 (PDQ-39)
timeFrame: Collected at Baseline, 3 and 6 month follow up
measure: Unified Parkinson's Disease Rating Scale (UPDRS)
timeFrame: Collected at Baseline, 3 and 6 month follow up
measure: Activity
timeFrame: Collected up to 6 months.
measure: Activity Monitor Data
timeFrame: Collected up to 6 months.
measure: Short Form 12 (SF12)
timeFrame: Collected at baseline, 3 and 6 month follow up visit
measure: Lindop Parkinson's Assessment Scale [LPAS]
timeFrame: Collected at baseline, 3 and 6 month follow up visit
measure: Mini Balance Evaluation Systems Test (mini-BEST)
timeFrame: Collected at baseline, 3 and 6 month follow up visits
measure: Tragus to Wall distance (posture assessment)
timeFrame: Collected at baseline, 3 and 6 month follow up visits
measure: Number of Falls
timeFrame: Collected at baseline , 3 month and 6 month follow up visits.
Other outcomes:
Locations:
Study officials:
affiliation: University Hospitals of Derby and Burton NHS Foundation Trust
name: Robert Skelly
role: PRINCIPAL_INVESTIGATOR
References: