Increasing Physical Activity in Stroke Survivors Using STARFISH

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by NHS Greater Glasgow and Clyde
Sponsor:
Collaborator:
University of Glasgow
Information provided by (Responsible Party):
NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier:
NCT01792349
First received: January 28, 2013
Last updated: February 14, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Stroke
Behavioral: STARFISH intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Increasing Physical Activity in Stroke Survivors Using STARFISH, an Interactive Mobile Phone Application: a Feasibility Study

Further study details as provided by NHS Greater Glasgow and Clyde:

Primary Outcome Measures:
  • The number of steps taken per day by participants in each group [ Time Frame: at baseline & at 6 weeks post randomisation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The Ten-Meter Walking Test (10 MWT) assessing walking speed (m/sec) over a 10m distance [ Time Frame: at baseline & at 6 weeks post randomisation ] [ Designated as safety issue: No ]
  • Fatigue Severity Scale (FSS) (evaluates the impact of fatigue) [ Time Frame: at baseline & at 6 weeks post randomisation ] [ Designated as safety issue: No ]
  • Instrumental Activities of Daily Living Scale [ Time Frame: at baseline & at 6 weeks post randomisation ] [ Designated as safety issue: No ]
  • Stroke Specific Quality of Life Scale (SS-QOL) [ Time Frame: at baseline & at 6 weeks post randomisation ] [ Designated as safety issue: No ]
  • Psychological General Well-Being (PGWB) Index [ Time Frame: at baseline & at 6 weeks post-randomisation ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: February 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: STARFISH intervention
STARFISH is a smartphone-based programme designed as a behavioural intervention to encourage the user to become more physically active
Behavioral: STARFISH intervention
STARFISH is a behavioural intervention to encourage the user to become more physically active
No Intervention: Control group
A smartphone application will record levels of physical activity, but subjects will not have access to daily step count or to the STARFISH application.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • history of serious cardiac disease (e.g. myocardial infarction, unstable angina)
  • uncontrolled blood pressure
  • significant neurological or musculoskeletal conditions in addition to stroke
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01792349

Contacts
Contact: Lorna Paul, Ph.D 44-141-330-6876 lorna.paul@glasgow.ac.uk

Locations
United Kingdom
NHS Greater Glasgow & Clyde Recruiting
Glasgow, United Kingdom
Contact: Lorna Paul, Ph.D.    44-141-330-6876    lorna.paul@glasgow.ac.uk   
Principal Investigator: Lorna Paul, Ph.D         
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
University of Glasgow
Investigators
Study Director: Lorna Paul, Ph.D University of Glasgow
  More Information

Publications:
Responsible Party: NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT01792349     History of Changes
Other Study ID Numbers: GN12NE530
Study First Received: January 28, 2013
Last Updated: February 14, 2013
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014