NCT02720276

Brief Summary

The purpose of this exploratory study is to investigate how a predetermined outdoor walking program (12 weeks) is best delivered to individuals with stroke over 18 years, either by smartphone and the Short Message Service (SMS) or video link. Furthermore, the aim is to investigate how the study design works in practice and determine the effects of the outdoor walking exercise program in combination with a leg exercise on physical functioning (walking capacity, gait speed, mobility and grip strength).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable

Status
completed

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

Study Start

First participant enrolled

October 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 25, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

September 19, 2017

Status Verified

September 1, 2017

Enrollment Period

8 months

First QC Date

March 16, 2016

Last Update Submit

September 17, 2017

Conditions

Keywords

strokeexercisewalkingmobility

Outcome Measures

Primary Outcomes (1)

  • 6 Minutes Walk Test

    walking capacity

    change from baseline walking capacity to three months

Secondary Outcomes (8)

  • Short Physical Performance Battery

    change from baseline mobility to three months

  • 10 meters walk test

    change from baseline gait speed to three months

  • Montreal Outcome Assessment

    baseline

  • Modified Rankin Scale

    baseline

  • Saltin Grimby Physical Activity Level Scale

    baseline

  • +3 more secondary outcomes

Study Arms (1)

Training after acute stroke

EXPERIMENTAL

Intervention: Outdoor walking and strength training.

Other: Training after acute stroke

Interventions

Outdoor walking: Participants will receive daily training instructions via Short message Service (SMS) over 12 weeks. The walks are increased in frequency and intensity. The intensity are rated using the Borg scale to 12-15. The first 2 weeks begins with daily walks of 10 minutes. The last 4 weeks the walk training will partly be performed in intervals in combination with conventional outdoor walks. The interval training includes warming-up (5 minutes), fast walking for 4 minutes alternated with slower walking for three minutes. This is repeated 3 times, followed by cooling down for about five minutes. Strength training: to repeatedly get up from sitting. Number of repetitions will increase from 5-20 per set and will be performed daily in 3 sets with a short rest between each set.

Training after acute stroke

Eligibility Criteria

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

You may qualify if:

  • ≥ 18 years
  • Verified ischemic cerebral infarction or intracerebral hemorrhage.
  • Sufficient walking capacity and motor function
  • Able to communicate in Swedish
  • Signed consent

You may not qualify if:

  • Are one or more of the following:
  • Subarachnoid bleeding
  • Insufficient cognition and impaired ability to understand instructions
  • Medical problems that make it unsuitable to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

StrokeMotor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavior

Study Officials

  • Birgit Vahlberg, Med Dr, RPT

    VO Paramedicin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Med Dr, RPT

Study Record Dates

First Submitted

March 16, 2016

First Posted

March 25, 2016

Study Start

October 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

September 19, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share