Parkinson DiseaseKEEPNCT05253040
KEEP Intervention for People Newly Diagnosed With Parkinson's
A study testing KEEP Intervention in people with Parkinson Disease, run by University of Cambridge at 1 site in United Kingdom.
Trial summary
Parkinson's Disease (PD) is a progressive neurological condition that affects movement, balance and cognition, resulting in loss of independence and compromised quality of life over the course of the condition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- KEEP Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Jun 2022to 18 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Idiopathic Parkinson's Disease
- Within 12 months since diagnosis
- Stable medication regime for four weeks prior to initiation of trial
- Ability to understand written English
Who cannot join
- Acute illness
- History of neurological disorder other than Parkinson Disease
- Diagnosis of dementia or significant cognitive impairments
- Participation in NHS structured PD-specific education program with or without exercise classes in the last year
- Unable to understand written English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: KEEP- A Randomised Feasibility Study of a Co-designed Physical Health Education Intervention to Improve Knowledge, Exercise Efficacy and Participation for Newly Diagnosed People With Parkinson's.
Parkinson's Disease (PD) is a progressive neurological condition that affects movement, balance and cognition, resulting in loss of independence and compromised quality of life over the course of the condition. Research suggests that those detrimental outcomes can be reduced through physical activity (PA) and exercise, especially when those are started early. Educating people with Parkinson's (PwP) on the role of PA and exercise in PD progression can boost PA engagement by increasing enablers such as exercise self-efficacy and removing barriers such as misinformation about exercise and exercise outcomes.
Working closely with PwP and healthcare professionals, a physical health education programme was co-designed to address the needs and preferences of PwP around exercise and PA education. The process was supervised by the patient and Public Involvement group attended by PwP, academics, researchers and clinicians working with PwP.
Read more
The study will utilise an assessor blinded randomised controlled design to investigate the acceptability and feasibility of delivering an online physical health education programme for PwP who are newly diagnosed. Thirty PwP, diagnosed in the last 12-months, will be randomly allocated into two groups: 1) the intervention group in which participants will receive online education modules and will be invited to attend virtual group sessions with a specialist neuro-physiotherapist; 2) the control group which will follow the usual care pathway and participants will receive Parkinson's UK booklets.
The aim of the study is to explore an alternative approach to standard care regarding patient education in PD and evaluate the feasibility and acceptability of a co-designed education intervention for newly diagnosed PwP delivered online. Feasibility data will be collected during the study and acceptability data will be assessed via a questionnaire at the end. Outcomes including PA levels, exercise knowledge, exercise efficacy, and participation will be assessed at baseline, post-intervention and at 6 months.
- Conditions
- Parkinson Disease
- Being tested
- KEEP Intervention, control
- Keywords
- Physical activity, education, exercise, self-efficacy
- Medical subject headings
- Parkinson Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KEEP InterventionOther
Educational intervention
controlOther
booklet from Parkinson's UK
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The experimental group will receive:
Online education modules Online group discussions facilitated by Specialist Physiotherapist Receives: Other: KEEP Intervention |
| Control Group | Active comparator | The comparator for this study is usual care pathway. Under the usual care pathway, participants will receive education booklets on exercise by Parkinson's UK. Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability assessment 1: Recruitment rate
Assessment of recruitment rate of study (% of eligible participants enrolled)
Measured: Through study completion (12 months)
Acceptability assessment 2: Education programme compliance
Compliance with the online education programme (% of sessions completed)
Measured: Through study completion (12 months)
Acceptability assessment 3: Drop out rate
Comparison of drop out rates (%) between the intervention group and control group
Measured: Through study completion (12 months)
Acceptability assessment 4: Acceptability of Intervention
A questionnaire designed to assess satisfaction with the education intervention. it includes multiple choice and open ended questions.
Measured: Completed at the end of participation in the study (after 8 weeks)
Feasibility of delivering the intervention online
Assessment of any technical problems or difficulties accessing online intervention as reported by participants
Measured: Through study completion (12 months)
Secondary outcomes (11)
Unified Parkinson's Disease Rating Scale Part 3
The UPDRS is the gold-standard scale for Parkinson's assessment and has four parts. For this study only UPDRS III, motor examination will be completed by a trained assessor. UPDRS III total scores range from 7 to 86 points, with higher scores indicating more severe impairment..
Measured: Baseline(week 0) and follow up (6-month post intervention)
MiniBESTest
The Mini-BEST is a 14-item scale that assesses dynamic balance components including anticipatory postural adjustments, reactive postural control, sensory orientation and dynamic gait. The data is based on a total score of 28 points, with higher score indicating better task performance.
Measured: Baseline(week 0) and follow up (6-month post intervention)
Five time Sit To Stand
Five time sit to stand is a validated test used to assess functional lower extremity strength, balance and risk falls in older adults. It has been used in PD population with high interrater and test-retest reliability. Longer time to complete indicates worse task performance.
Measured: Baseline(week 0) and follow up (6-month post intervention)
Self-efficacy for Exercise
The Self-Efficacy for exercise (SEE) scale is a 9-item validated scale which assesses a person self-efficacy to exercise under different circumstances. This scale is a modified version of Bandura's Exercise Self-Efficacy Scale and ask participants to rate their perceived exercise efficacy on a scale form 0 meaning not confident at all to 10 meaning very confident. Higher score indicate higher self-efficacy
Measured: Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
Hospital Anxiety and Depression Scale
Hospital Anxiety and Depression Scale (HADS) is a widely used questionnaire to measure anxiety and depression. A self-reported brief instrument which includes 14 questions aiming to detect and indicate severity of anxiety and depression. It has been used before and is a validated and reliable tool to use in Parkinson's population.
Measured: Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
Apathy Evaluation Scale
Apathy Evaluation Scale (AES) is a standardised and validated self-rating instrument to evaluate apathy. It consists of 18 items that are scored on a 4-point Likert Scale, with highest score indicating more severe apathy
Measured: Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
Multidimensional Outcome Expectation Scale
Outcome expectations about the benefits of regular exercise and PA will be measured by the Multidimensional Outcomes Expectations for Exercise Scale (MOEES). The MOEES has 15 items that reflect three subdomains of outcome expectations. The items were rated on a five-point scale from 1 (Strongly disagree) to 5 (Strongly agree) and summed to form the subscale measures of outcome expectations with higher scores reflecting greater beliefs about the benefits of regular exercise and physical activity.
Measured: Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
Oxford Participation and Activities Questionnaire
Oxford Participation and Activities Questionnaire (Ox-PAQ) is a patient-reported outcome measure comprised of 23 items aiming to assess participation and activity in patients with long-term conditions.
Measured: Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
Recent Physical Activity Questionnaire
Physical Activity will be measured subjectively and objectively. Subjectively it will be measured via the self-reported Recent Physical Activity Questionnaire (RPAQ), which is designed to assess PA in everyday life in the last 4 weeks. The questionnaire has three sections assessing a range of activities in different domains (around the house, work and recreation).
Measured: Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
Knowledge of Exercise and Physical Activity
Knowledge of Exercise and Physical Activity questionnaire is a 10-item knowledge questionnaire around the role of exercise and physical activity in the management of PD and it has been designed by the PI to assess knowledge levels. A total score of 10 indicates better knowledge scores.
Measured: Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
Wrist-worn accelerometer
Objectively, physical activity will be measured with the use of a wrist-worn accelerometer (GeneActiv monitor) over 7 consecutive days.
Measured: Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start18 Jun 2022
- Primary completion21 Sep 2022
- Study completion18 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ledia Alushi, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05253040
- Sponsor's protocol ID
- A096150
- Acronym
- KEEP
- Status last verified
- Nov 2022
- First submitted
- 2 Feb 2022
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Agley L, Hartley P, Duffill D, Iqbal A, Mackett A, Rennie KL, Lafortune L. Digital Intervention Promoting Physical Activity in People Newly Diagnosed with Parkinson's Disease: Feasibility and Acceptability of the Knowledge, Exercise-Efficacy and Participation (KEEP) Intervention. J Parkinsons Dis. 2024;14(6):1193-1210. doi: 10.3233/JPD-240071.
PubMed 39093079
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KEEP- A Randomised Feasibility Study of a Co-designed Physical Health Education Intervention to Improve Knowledge, Exercise Efficacy and Participation for Newly Diagnosed People With Parkinson's.
- ClinicalTrials.gov ID
- NCT05253040
- Acronym / sponsor ID
- KEEP / A096150
- Conditions
- Parkinson Disease
- Keywords
- Physical activity, education, exercise, self-efficacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Study start
- 18 Jun 2022 (actual)
- Primary completion
- 21 Sep 2022 (actual)
- Study completion
- 18 Jun 2023 (estimated)
- First posted
- 23 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Parkinson's Disease (PD) is a progressive neurological condition that affects movement, balance and cognition, resulting in loss of independence and compromised quality of life over the course of the condition. Research suggests that those detrimental outcomes can be reduced through physical activity (PA) and exercise, especially when those are started early. Educating people with Parkinson's (PwP) on the role of PA and exercise in PD progression can boost PA engagement by increasing enablers such as exercise self-efficacy and removing barriers such as misinformation about exercise and exercise outcomes.
Working closely with PwP and healthcare professionals, a physical health education programme was co-designed to address the needs and preferences of PwP around exercise and PA education. The process was supervised by the patient and Public Involvement group attended by PwP, academics, researchers and clinicians working with PwP.
The study will utilise an assessor blinded randomised controlled design to investigate the acceptability and feasibility of delivering an online physical health education programme for PwP who are newly diagnosed. Thirty PwP, diagnosed in the last 12-months, will be randomly allocated into two groups: 1) the intervention group in which participants will receive online education modules and will be invited to attend virtual group sessions with a specialist neuro-physiotherapist; 2) the control group which will follow the usual care pathway and participants will receive Parkinson's UK booklets.
The aim of the study is to explore an alternative approach to standard care regarding patient education in PD and evaluate the feasibility and acceptability of a co-designed education intervention for newly diagnosed PwP delivered online. Feasibility data will be collected during the study and acceptability data will be assessed via a questionnaire at the end. Outcomes including PA levels, exercise knowledge, exercise efficacy, and participation will be assessed at baseline, post-intervention and at 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: KEEP InterventionThe experimental group will receive: Online education modules Online group discussions facilitated by Specialist Physiotherapist |
| Control Group | Active comparator | Other: controlThe comparator for this study is usual care pathway. Under the usual care pathway, participants will receive education booklets on exercise by Parkinson's UK. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of Idiopathic Parkinson's Disease
- Within 12 months since diagnosis
- Stable medication regime for four weeks prior to initiation of trial
- Ability to understand written English
Key exclusion criteria (5 listed)
- Acute illness
- History of neurological disorder other than Parkinson Disease
- Diagnosis of dementia or significant cognitive impairments
- Participation in NHS structured PD-specific education program with or without exercise classes in the last year
- Unable to understand written English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KEEP InterventionEducational intervention | Other | Intervention group |
| controlbooklet from Parkinson's UK | Other | Control Group |
Primary outcome
Acceptability assessment 1: Recruitment rate
Time frame: Through study completion (12 months)
Assessment of recruitment rate of study (% of eligible participants enrolled)
Acceptability assessment 2: Education programme compliance
Time frame: Through study completion (12 months)
Compliance with the online education programme (% of sessions completed)
Acceptability assessment 3: Drop out rate
Time frame: Through study completion (12 months)
Comparison of drop out rates (%) between the intervention group and control group
Acceptability assessment 4: Acceptability of Intervention
Time frame: Completed at the end of participation in the study (after 8 weeks)
A questionnaire designed to assess satisfaction with the education intervention. it includes multiple choice and open ended questions.
Feasibility of delivering the intervention online
Time frame: Through study completion (12 months)
Assessment of any technical problems or difficulties accessing online intervention as reported by participants
11 secondary outcomes
Unified Parkinson's Disease Rating Scale Part 3
Time frame: Baseline(week 0) and follow up (6-month post intervention)
MiniBESTest
Time frame: Baseline(week 0) and follow up (6-month post intervention)
Five time Sit To Stand
Time frame: Baseline(week 0) and follow up (6-month post intervention)
Self-efficacy for Exercise
Time frame: Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
Hospital Anxiety and Depression Scale
Time frame: Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
Apathy Evaluation Scale
Time frame: Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
Multidimensional Outcome Expectation Scale
Time frame: Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
Oxford Participation and Activities Questionnaire
Time frame: Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
Recent Physical Activity Questionnaire
Time frame: Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
Knowledge of Exercise and Physical Activity
Time frame: Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
Wrist-worn accelerometer
Time frame: Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Derived from this study: PubMed 39093079Agley L, Hartley P, Duffill D, Iqbal A, Mackett A, Rennie KL, Lafortune L. Digital Intervention Promoting Physical Activity in People Newly Diagnosed with Parkinson's Disease: Feasibility and Acceptability of the Knowledge, Exercise-Efficacy and Participation (KEEP) Intervention. J Parkinsons Dis. 2024;14(6):1193-1210. doi: 10.3233/JPD-240071.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KEEP Intervention in people with Parkinson Disease, run by University of Cambridge at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability assessment 1: Recruitment rate (time frame: Through study completion (12 months)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05253040, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.