NCT02494245

Brief Summary

The aim of the study is to compare physical activity in stroke survivors who have undertaken a four month physical activity intervention using the STARFISH application with a control group receiving four months of usual care.

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
128

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable stroke

Geographic Reach
1 country

4 active sites

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

July 1, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 10, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

June 1, 2017

Status Verified

May 1, 2017

Enrollment Period

2 years

First QC Date

July 1, 2015

Last Update Submit

May 30, 2017

Conditions

Stroke

Keywords

RehabilitationInterventionWalking

Outcome Measures

Primary Outcomes (1)

  • Change in the mean number of steps per day

    measured with an ActivPAL activity monitor (PAL Technologies, Glasgow, Scotland)

    Baseline, 4 months, 6 months

Secondary Outcomes (16)

  • Change in sedentary time

    Baseline, 4 months, 6 months

  • Change in the Six-Minute Walk Test (6MWT)

    Baseline, 4 months, 6 months

  • change in 10-Metre Walking Test (10MWT)

    Baseline, 4 months, 6 months

  • Change in the Nottingham Extended Activities of Daily Living Scale (EADL)

    Baseline, 4 months, 6 months

  • Change in Fatigue Severity Scale (FSS)

    Baseline, 4 months, 6 months

  • +11 more secondary outcomes

Study Arms (2)

Intervention

ACTIVE COMPARATOR

128 participants will take part in the STARFISH intervention

Other: STARFISH

Control

NO INTERVENTION

Participants allocated to the control group will be given a booklet with general advice on physical activity.

Interventions

STARFISHOTHER

The intervention group will take part in a four month physical activity intervention using the STARFISH app with the aim of increasing physical activity by 3000 steps per day. Participants will be provided with a smartphone for the intervention. Participants will work in groups of four but each participant will have their own individualised step count target, based on their baseline step count. If the participant reaches their step count target on at least five days of the week, then their target will be increased by 5% for the following week, up to a maximum increase of 3000 steps above baseline. Where a participant fails to reach their step count target, it remains unchanged for the following week.

Intervention

Eligibility Criteria

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

You may qualify if:

  • single unilateral stroke
  • discharged from active rehabilitation
  • the ability to walk independently, with or without using an aid or orthosis
  • the ability to comprehend instruction

You may not qualify if:

  • a history of serious cardiac disease (e.g. myocardial infarction, unstable angina) in the previous six months
  • uncontrolled blood pressure
  • significant neurological or musculoskeletal conditions in addition to stroke
  • currently participating in another clinical trial (rehabilitation or pharmacological)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

NHS Forth Valley

Falkirk, United Kingdom

RECRUITING

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom

RECRUITING

NHS Lanarkshire

Glasgow, United Kingdom

RECRUITING

NHS Ayrshire &Arran

Irvine, United Kingdom

RECRUITING

Related Publications (9)

  • Michael KM, Allen JK, Macko RF. Reduced ambulatory activity after stroke: the role of balance, gait, and cardiovascular fitness. Arch Phys Med Rehabil. 2005 Aug;86(8):1552-6. doi: 10.1016/j.apmr.2004.12.026.

    PMID: 16084807RESULT

  • Gresham GE, Fitzpatrick TE, Wolf PA, McNamara PM, Kannel WB, Dawber TR. Residual disability in survivors of stroke--the Framingham study. N Engl J Med. 1975 Nov 6;293(19):954-6. doi: 10.1056/NEJM197511062931903.

    PMID: 1178004RESULT

  • Alzahrani MA, Ada L, Dean CM. Duration of physical activity is normal but frequency is reduced after stroke: an observational study. J Physiother. 2011;57(1):47-51. doi: 10.1016/S1836-9553(11)70007-8.

    PMID: 21402330RESULT

  • Michael K, Macko RF. Ambulatory activity intensity profiles, fitness, and fatigue in chronic stroke. Top Stroke Rehabil. 2007 Mar-Apr;14(2):5-12. doi: 10.1310/tsr1402-5.

    PMID: 17517569RESULT

  • Rand D, Eng JJ, Tang PF, Hung C, Jeng JS. Daily physical activity and its contribution to the health-related quality of life of ambulatory individuals with chronic stroke. Health Qual Life Outcomes. 2010 Aug 3;8:80. doi: 10.1186/1477-7525-8-80.

    PMID: 20682071RESULT

  • 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: 15735997RESULT

  • Paul L, Brewster S, Wyke S, Gill JM, Alexander G, Dybus A, Rafferty D. Physical activity profiles and sedentary behaviour in people following stroke: a cross-sectional study. Disabil Rehabil. 2016;38(4):362-7. doi: 10.3109/09638288.2015.1041615. Epub 2015 May 4.

    PMID: 25936730RESULT

  • Fitzsimons CF, Baker G, Wright A, Nimmo MA, Ward Thompson C, Lowry R, Millington C, Shaw R, Fenwick E, Ogilvie D, Inchley J, Foster CE, Mutrie N. The 'Walking for Wellbeing in the West' randomised controlled trial of a pedometer-based walking programme in combination with physical activity consultation with 12 month follow-up: rationale and study design. BMC Public Health. 2008 Jul 26;8:259. doi: 10.1186/1471-2458-8-259.

    PMID: 18655723RESULT

  • 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

Central Study Contacts

Aleksandra Dybus, PhD

CONTACT

0141 330 5536aleksandra.dybus@glasgow.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Reader in Rehabilitation

Study Record Dates

First Submitted

July 1, 2015

First Posted

July 10, 2015

Study Start

October 1, 2015

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

June 1, 2017

Record last verified: 2017-05

Locations

GB(4)