ReFresh study: rehabilitation for fatigue in people with Parkinson's
| ISRCTN | ISRCTN62114944 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62114944 |
- Submission date
- 12/02/2024
- Registration date
- 27/02/2024
- Last edited
- 27/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English Summary
Background and study aims
The aim of this study is to assess the acceptability and practicality of the ReFresh online fatigue management program and the research design of the fully-powered randomized controlled trial (RCT). It will identify the best fatigue measure to use as the primary outcome. It will also provide the information needed to conduct a power calculation to inform the design of a fully-powered RCT. This research focuses on improving fatigue levels and hence the quality of life for people with Parkinson's disease by investigating the ReFresh Online Fatigue Management Program.
Who can participate?
Adults aged 18 years and over with Parkinson's disease and self-identified fatigue
What does the study involve?
Participants will fill in a survey at the start about their Parkinson’s, their experiences of fatigue, and their everyday activities and quality of life. It will take about 30 minutes to complete. Participants will then be put into the ReFresh program or waitlist groups by chance (randomization). They will receive an email either with the link to the online ReFresh program or be asked to be part of the waitlist group. The ReFresh online program will ask participants to watch six online sessions and undertake some homework over 6 weeks. Each session will last around 30 minutes with a further 30-60 minutes of homework (including exercise). After 12 weeks both groups will be asked to complete another survey similar to the baseline survey. Those who accessed the online ReFresh program will be asked their opinion of it. After 16 weeks the waitlist group will be emailed a link to the online ReFresh program which they can undertake if they wish. Uptake will not be recorded.
What are the possible benefits and risks of participating?
The researchers will encourage everyone who takes part in the ReFresh online program to undertake around 30 minutes of exercise three times a week. They will provide links to online videos of exercise programs led by physiotherapists, and recommend other types of exercise. These are recommendations and how much exercise participants manage will be measured as part of the study. If participants have any concerns about taking on an exercise program (particularly if they have another health condition that may increase risk such as lung or heart disease) they are recommended to talk to their GP or clinical team about what exercise is appropriate for them. If they are unable to undertake any exercise, this research project is not suitable for them.
Additionally, people with Parkinson’s are at increased risk of falls, and participants are asked to be mindful of this risk. For example, they are recommended to clear a generous space if doing exercise at home, and maybe place a phone nearby if they don’t have anyone at home with them when exercising. The researchers will be asking about any falls and injuries resulting from a fall as part of the study.
The participants will be asked to think about how they cope mentally and physically with fatigue and Parkinson’s. This can sometimes be distressing. If participants think they might benefit from talking to someone about their mental health and wellbeing the researchers highly recommend the services provided by the mental health charity MIND (https://www.mind.org.uk/information-support/). For support related specifically to Parkinson's disease, they recommend reaching out to Parkinson's UK (https://www.parkinsons.org.uk/information-and-support/support-you). They can be contacted through their free confidential helpline at 0808 800 0303 (Monday to Friday, 9 am to 6 pm, and 10 am to 2 pm on Saturdays) or by emailing hello@parkinsons.org.uk.
Where is the study run from?
University of East Anglia (UK)
When is the study starting and how long is it expected to run for?
January 2023 to August 2024
Who is funding the study?
King Saud University (Saudi Arabia)
Who is the main contact?
1. Sarah Alageel, S.alageel@uea.ac.uk
2. Dr Katherine Deane, k.deane@uea.ac.uk
Contact information
Public, Scientific, Principal Investigator
Skipper House 130 Ber Street
Norwich
NR1 3EZ
United Kingdom
 ORCID ID |
0000-0001-5406-6679 |
|---|---|
| Phone | +44 (0)7564878159 |
| s.alageel@uea.ac.uk |
Study information
| Study design | Pilot randomized controlled trial with two parallel comparator groups |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual |
| Study type | Quality of life |
| Participant information sheet | 45033_PIS_V1_14Dec23.pdf |
| Scientific title | Pilot randomized controlled trial protocol – ReFresh Study: rehabilitation for fatigue in people with Parkinson’s |
| Study hypothesis | This study is a pilot randomized controlled trial (RCT). Its purpose is to assess the acceptability and practicality of the ReFresh online fatigue management program and the research design of the RCT evaluation. It will identify the best fatigue measure to use as the primary outcome. It will also provide us with the information needed to conduct a power calculation to inform the design of a fully powered randomised controlled trial. The ReFresh online fatigue management program, when compared to standard care, will result in a statistically significant reduction in perceived fatigue levels among individuals diagnosed with Parkinson's disease. Specifically, it is hypothesised that participants engaging in the ReFresh program will demonstrate a greater decrease in fatigue severity scores over 12 weeks. This hypothesis is based on the assumption that the targeted strategies and interventions included in the ReFresh program will positively influence fatigue management in this population. |
| Ethics approval(s) |
Approved 15/04/2024, University of East Anglia’s Faculty of Medicine and Health’s Research Ethics Committee (University of East Anglia Norwich Research Park, Norwich, NR4 7TJ, United Kingdom; +44 (0)1603 456161; University.secretary@uea.ac.uk), ref: ETH2324-0159 |
| Condition | Parkinson's disease |
| Intervention | Participants will be randomized using the Sealed Envelope website in a 1:1 ratio to either the intervention (ReFresh program) or control (waitlist) group. The ReFresh group will access online modules and exercise recommendations, while the waitlist group receives usual care. Upon completion of the baseline data collection phase, participants will be subjected to randomization into either the intervention arm (fatigue management) or the control arm (waitlist) using the Sealed Envelope website. Sealed Envelope provides a robust online software application for randomizing patients in clinical trials and capturing case report form data (EDC and ePRO). For this trial, the Simple randomization service offered by Sealed Envelope will be utilized. This employs a pseudo-randomization number generator and will allocate participants in a 1:1 ratio to either the ReFresh program or the waitlist. To ensure a balanced distribution of patients between the two arms throughout the trial, participants will be allocated in randomly permuted blocks of 4 and 6 (Sealed Envelope Ltd. 2022). A unique password will be assigned for the trial, allowing authorized personnel to conduct new randomizations. The results will be promptly displayed on-screen and emailed to both the trial administrator and the assigned individual overseeing the randomization process, ensuring transparency and accountability. Upon allocation, participants will receive an email notifying them of their assignment. Those allocated to the ReFresh group will be provided with the link to access the online program. Conversely, participants assigned to the waitlist group will be informed that they will be contacted again in 12 weeks to complete the endpoint survey. At 16 weeks, they will receive the link to the ReFresh program to prevent contamination of the control group. Intervention Group: Participants randomized to this arm will gain access to the online fatigue management webpage. They will progress through the online resources at their own pace, although it is recommended they complete one module per week and participate in an exercise program at least three times per week. The program consists of six modules. Participants' usage of the online resources will be tracked, and completion of the fatigue management program will be defined as accessing at least four of the six modules. Control Group: Participants in the control arm will be placed on a waitlist for 4 months to access the online fatigue management program. They will receive usual care for their Parkinson’s, attending consultant and nurse specialist appointments as scheduled based on their clinical needs. No additional contact or information regarding fatigue management will be provided. Blinding: Blinding to group allocation will not be feasible, as participants will be aware of whether they have access to the online fatigue management program. All assessments will be completed by participants via online surveys. The trial data will be analysed by SA, who will not be blinded to allocation. The study aims to assess the implementation of study processes, evaluate the acceptability and practicality of the ReFresh intervention, and determine the best fatigue measure to use in a fully powered RCT. The primary outcome, fatigue at 12 weeks, is measured using the Parkinson’s Fatigue Scale (PFS) and the Modified Fatigue Impact Scale (MFIS) at baseline and 12 weeks. Given the nature of the intervention (online educational program), blinding is not feasible. The study aims to assess the implementation of study processes, determine the acceptability and practicality of the ReFresh intervention, and evaluate the best fatigue measure to use as the primary outcome measure for a fully powered randomized controlled trial. The selected primary measure’s data will inform the sample size calculation for the subsequent fully powered RCT. |
| Intervention type | Behavioural |
| Primary outcome measure | Fatigue assessed using the Parkinson’s Fatigue Scale (PFS) and the Modified Fatigue Impact Scale (MFIS) at 12 weeks |
| Secondary outcome measures | 1. Quality of life measured using the Parkinson's Disease Questionnaire (PDQ-39) at baseline and 12 weeks 2. Anxiety measured using the Parkinson Anxiety Scale (PAS) at baseline and 12 weeks 3. Depression measured using the Geriatric Depression Scale-15 (GDS-15) at baseline and 12 weeks 4. Sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI) at baseline and 12 weeks 5. Self-efficacy measured using Multiple Sclerosis-Fatigue Self– Efficacy (MS-FSE) at baseline and 12 weeks 6. Fatigue-related goals measured using the Canadian Occupational Performance Measure (COPM) at baseline and 12 weeks 7. Incidence of falls measured using self-report throughout the study |
| Overall study start date | 29/01/2023 |
| Overall study end date | 01/08/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 20 |
| Total final enrolment | 109 |
| Participant inclusion criteria | 1. People with a clinical diagnosis of idiopathic Parkinson’s disease 2. Aged 18 years and over 3. Living in England 4. English speaking 5. Literate 6. Internet access |
| Participant exclusion criteria | 1. Any diagnoses of other Parkinsonian conditions (e.g., vascular Parkinsonism, progressive supranuclear palsy, multiple system atrophy, Lewy body dementia) 2. Anyone who has been clinically recommended to not undertake exercise |
| Recruitment start date | 14/06/2024 |
| Recruitment end date | 25/06/2024 |
Locations
Countries of recruitment
- England
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centre
United Kingdom
Sponsor information
University/education
Riyadh
Riyadh
P.BOX 145111 Zip 4545
Saudi Arabia
| Phone | +966 (0)114670000 |
|---|---|
| info@ksu.edu.sa | |
| Website | http://ksu.edu.sa/en/ |
"ROR" |
https://ror.org/02f81g417 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- جامعة الملك سعود, KSU
- Location
- Saudi Arabia
Results and Publications
| Intention to publish date | 01/07/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | The study results are planned to be published in a peer-reviewed journal. |
| IPD sharing plan | The anonymized datasets generated during and/or analysed during the current study will be stored in a non-publicly available repository. Access to the datasets can be requested from the principal investigator, PGR Student Sarah alageel at S.alageel@uea.ac.uk. The data-sharing plan includes sharing relevant data with qualified researchers for further analysis, subject to approval based on research objectives and ethical considerations. Consent from participants includes provisions for data sharing while ensuring privacy and confidentiality. Access to the data will be granted based on established criteria, and efforts will be made to anonymize the data appropriately. Ethical and legal restrictions will be upheld to protect participant confidentiality and comply with data protection regulations. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1 | 14/12/2023 | 20/02/2024 | No | Yes |
| Protocol file | 20/02/2024 | No | No | ||
| Statistical Analysis Plan | 20/02/2024 | No | No |
Additional files
Editorial Notes
27/08/2024: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/05/2024 to 14/06/2024.
2. The recruitment end date was changed from 01/08/2024 to 25/06/2024.
3. The total final enrolment was added.
15/05/2024: The overall study end date was changed from 01/07/2024 to 01/08/2024.
10/05/2024: The following changes were made to the study record:
1. Ethics approval details added.
2. The recruitment start date was changed from 01/03/2024 to 01/05/2024.
3. The recruitment end date was changed from 01/04/2024 to 01/08/2024.
20/02/2024: Study's existence confirmed by the University of East Anglia’s Faculty of Medicine and Health’s Research Ethics Committee.
