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ReFresh study: rehabilitation for fatigue in people with Parkinson's

Pilot randomized controlled trial protocol – ReFresh Study: rehabilitation for fatigue in people with Parkinson’s

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN62114944
Enrollment
20
Registered
2024-02-27
Start date
2024-06-14
Completion date
Unknown
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's disease Nervous System Diseases

Interventions

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

Sponsors

King Saud University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 120 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Fatigue assessed using the Parkinson’s Fatigue Scale (PFS) and the Modified Fatigue Impact Scale (MFIS) at 12 weeks

Secondary

MeasureTime frame
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

Countries

England, Northern Ireland, Scotland, United Kingdom, Wales

Contacts

Public ContactSarah Alageel
s.alageel@uea.ac.uk+44 (0)7564878159

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 17, 2026