Digital Coaching With" Physical Activity on Prescription ( FaR) to Increase Physical Activity and Reduce Post Stroke Fatigue

NCT05573867 | Recruiting

• 1 other identifier: 279072
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke is the leading cause in the world considering disabilities and approximately half of the patient population experience post stroke fatigue (PSF). PSF affects the patients level of activity and their quality of life. Even patients with mild stroke claim that PSF is one of the main reasons hindering them from being physically active. People suffering from stroke generally have lower physical capacity compared to healthy individuals of the same age and they are spending more time in sedentary. Physical inactivity is considered to be one of the main modifiable risk factors for stroke. There is strong evidence that physical activity will improve health and reduce the risk of future strokes. Evaluation of interventions to reduce PSF is a prioritized research field since it is currently lacking evidence. There is a possibility that physical training can have a positive effect on PSF. Digital alternatives to on-site visits will increase the availability and can strengthen the patients independence which is according to the government and Sveriges Kommuner och Regioner ( SKR) common vision for e-health. The aim of this study is to evaluate the feasibility of individualized, digital coaching twice a week for 12 weeks with "Physical activity on prescription" (FaR) to increase physical activity and reduce PSF after stroke.

Conditions

Treatment

Keywords

post stroke fatigue; digital coaching; physical activity; physical activity on prescription

Outcome Measures

Primary Outcomes (2)

• Swedish Fatigue Assessment Scale ( S-FAS)

  The S-FAS is a self administrated questionnaire to assess fatigue. The total scores ranges from 10 to 50. A total S-FAS score ≥24 indicates fatigue.

  Change between the 3 time points ( baseline, post and 6 months post intervention)

• ActivPaL

  The ActivPaL activity monitor is a small device worn on the thigh that uses information about static and dynamic acceleration to 1) distinguish body posture as sitting/lying, standing and stepping and 2) estimate energy expenditure (EE) (expressed as metabolic equivalents (METs)

  Change between the 3 time points ( baseline, post and 6 months post intervention)

Secondary Outcomes (3)

• GIH stationary single-item question ( SED-GIH) and activity level.

  Change between the 3 time points ( baseline, post and 6 months post intervention)

• Activities-specific Balance Confidence scale ( ABC)

  Change between the 3 time points ( baseline, post and 6 months post intervention)

• Exercise self-efficacy scale

  Change between the 3 time points ( baseline, post and 6 months post intervention)

Study Arms (2)

Intervention group

EXPERIMENTAL

Individualized, digital coaching twice a week for 12 weeks with "Physical activity on prescription" (FaR) to increase physical activity and reduce PSF after stroke.

Other: Physical activity on prescription

Control group

NO INTERVENTION

Control group receive routine written and verbal information about PSF and information about recommended level of physical activity.

Interventions

Physical activity on prescription OTHER

All participants, regardless of group affiliation, receive routine written and verbal information about PSF and information about recommended level of physical activity. Intervention group receive as add on individualized, digital coaching twice a week for 12 weeks with "Physical activity on prescription" (FaR) to increase physical activity and reduce PSF after stroke.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stroke 1 to 5 years ago
• Living in Gästrikland
• Post Stroke Fatigue ( S-FAS ≥ 24)

You may not qualify if:

• Severe stroke (Modified Rankin Scale \>3)
• Depression ( Geriatric Depression Scale \>5)

Sponsors & Collaborators

• Region Gävleborg: lead

Study Sites (1)

Region Gävleborg

Gävle, Sweden

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Ylva Nilsagård, MD

  County of Örebro

  STUDY CHAIR

Central Study Contacts

Maria Svedjebrant, PhD

CONTACT

+46722282142; maria.svedjebrant@regiongavleborg.se

Ylva Nilsagård, MD

CONTACT

+46706093737; ylva.nilsagard@regionorebrolan.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: October 10, 2022
• Study Start: June 12, 2023
• Primary Completion: June 12, 2025
• Study Completion: June 12, 2025
• Last Updated: February 23, 2024

Record last verified: 2024-02

Locations

SE (1)