NCT01792349

Brief Summary

There is good evidence of the effectiveness of regular physical activity in the primary and secondary prevention of stroke. STARFISH is a smartphone-based application designed as a behavioural change intervention to encourage the user to become more physically active. The study will investigate if using STARFISH for 6 weeks can increase physical activity in people after stroke. Subjects will be randomised to the STARFISH intervention or a control group. Control subjects will not have access to their daily activity count.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Feb 2013

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2013

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

February 15, 2013

Status Verified

February 1, 2013

Enrollment Period

10 months

First QC Date

January 28, 2013

Last Update Submit

February 14, 2013

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • The number of steps taken per day by participants in each group

    at baseline & at 6 weeks post randomisation

Secondary Outcomes (5)

  • The Ten-Meter Walking Test (10 MWT) assessing walking speed (m/sec) over a 10m distance

    at baseline & at 6 weeks post randomisation

  • Fatigue Severity Scale (FSS) (evaluates the impact of fatigue)

    at baseline & at 6 weeks post randomisation

  • Instrumental Activities of Daily Living Scale

    at baseline & at 6 weeks post randomisation

  • Stroke Specific Quality of Life Scale (SS-QOL)

    at baseline & at 6 weeks post randomisation

  • Psychological General Well-Being (PGWB) Index

    at baseline & at 6 weeks post-randomisation

Study Arms (2)

STARFISH intervention

EXPERIMENTAL

STARFISH is a smartphone-based programme designed as a behavioural intervention to encourage the user to become more physically active

Behavioral: STARFISH intervention

Control group

NO INTERVENTION

A smartphone application will record levels of physical activity, but subjects will not have access to daily step count or to the STARFISH application.

Interventions

STARFISH interventionBEHAVIORAL

STARFISH is a behavioural intervention to encourage the user to become more physically active

STARFISH intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Post stroke survivors of single unilateral stroke
  • discharged from rehabilitation
  • the ability to walk independently, with or without using an aid or orthosis
  • sufficient cognitive ability,
  • the ability to comprehend instruction

You may not qualify if:

  • history of serious cardiac disease (e.g. myocardial infarction, unstable angina)
  • uncontrolled blood pressure
  • significant neurological or musculoskeletal conditions in addition to stroke

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NHS Greater Glasgow & Clyde

Glasgow, United Kingdom

RECRUITING

Related Publications (4)

  • Donnan GA, Fisher M, Macleod M, Davis SM. Stroke. Lancet. 2008 May 10;371(9624):1612-23. doi: 10.1016/S0140-6736(08)60694-7.

    PMID: 18468545BACKGROUND

  • Ivey FM, Macko RF, Ryan AS, Hafer-Macko CE. Cardiovascular health and fitness after stroke. Top Stroke Rehabil. 2005 Winter;12(1):1-16. doi: 10.1310/GEEU-YRUY-VJ72-LEAR.

    PMID: 15735997BACKGROUND

  • Warburton DE, Nicol CW, Bredin SS. Health benefits of physical activity: the evidence. CMAJ. 2006 Mar 14;174(6):801-9. doi: 10.1503/cmaj.051351.

    PMID: 16534088BACKGROUND

  • Saunders DH, Mead GE, Fitzsimons C, Kelly P, van Wijck F, Verschuren O, Backx K, English C. Interventions for reducing sedentary behaviour in people with stroke. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD012996. doi: 10.1002/14651858.CD012996.pub2.

    PMID: 34184251DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Lorna Paul, Ph.D

    University of Glasgow

    STUDY DIRECTOR

Central Study Contacts

Lorna Paul, Ph.D

CONTACT

44-141-330-6876lorna.paul@glasgow.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2013

First Posted

February 15, 2013

Study Start

February 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

February 15, 2013

Record last verified: 2013-02

Locations

GB(1)