Sms-guided Training After Acute Stroke or Transient Ischemic Attack - a Randomized Controlled Trial (SMS/TIA)

September 17, 2017 updated by: Birgit Vahlberg, Uppsala County Council, Sweden

Effects of Sms-guided Outdoor Walking and Strength Training After Acute Stroke and TIA - a Randomized Controlled Trial

Eighty community-living individuals in Uppsala municipality will be included. Intervention: Outdoor walking exercise program and one strength exercise. Methods: Clinical assessments, questionnaires and medical records. Assessment of motor function, cognition, level of physical activity, food intake and perceived stress are performed at screening as baseline measurements. Walking capacity, mobility, handgrip strength, body composition and cardiovascular risk markers will be assessed at baseline and after 12 week of training. At one year after training health-related quality of life, another cardiovascular incidence and mortality will be documented.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Eighty community-living individuals in Uppsala municipality will be included in a randomized controlled trial with two arms.

Intervention: Participants will perform an outdoor walking exercise program together with one strength exercise for 12 weeks. The intensity and frequency of the training will progressively increase. Participants are supposed to walk and perform strength training 5-7 days/week.

Methods: Clinical assessments, questionnaires and medical records used for documentation of age, sex, comorbidity, blood pressure, medications and previous education.

Assessment of motor function, cognition, level of physical activity, food intake and perceived stress are performed at screening as baseline measurements. Walking capacity (primary outcome measure), mobility, handgrip strength, body composition and cardiovascular risk markers will be assessed at baseline and after 12 week of training. At one year after training health-related quality of life, another cardiovascular incidence and mortality will be evaluated.

Power analysis is performed. The investigators will analyze the data using an intention-to -treat analysis. Participants should have participated in at least 50% of the training sessions

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Verified ischemic cerebral infarction or intracerebral hemorrhage.
  2. Sufficient walking capacity and motor function
  3. Able to communicate in Swedish
  4. Signed consent

Exclusion Criteria:

One or more of the following:

  1. Subarachnoid bleeding
  2. Insufficient cognition and impaired ability to understand instructions
  3. Medical problems that make it unsuitable to participate
  4. Pacemaker (body composition measurements)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention:
Outdoor walking and strength exercise, Three months, daily SMS.
Other: Outdoor walking and strength exercise
Exercise group: Participants are supposed to perform an outdoor walking exercise program and one strength exercise for 12 weeks. The first 2 weeks start with daily walks. The intensity and frequency of walks will progressively increase performed according to the Borg scale: 12-15, ie, moderate to strenuous. Participants will walk 5-7 days/week. Added to this is a strength exercise, i.e. chair-rising which also should be performed daily.
Other Names:
  • exercise
Other: Control group
Usual care; no restriction for exercise, Three months
Other: control group
Control-Group: Treatment as usual for 12 weeks, without restriction of being physically active.
Other Names:
  • control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6 minute walk test (6MWT)
Time Frame: from baseline walking capacity to three months
walking capacity
from baseline walking capacity to three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short Physical Performance Battery (SPPB)
Time Frame: from baseline SPPB to three months
mobility
from baseline SPPB to three months
10 meter walk test (10mWT)
Time Frame: from baseline 10mWT to three months
gait speed
from baseline 10mWT to three months
Hand-dynamometer (Jamar)
Time Frame: from baseline Jamar to three months
hand-grip strength
from baseline Jamar to three months
Body composition (bioelectric impedance analysis)
Time Frame: from baseline body composition to three months
muscles and fat mass and BMI
from baseline body composition to three months
Cardiometabolic risk markers
Time Frame: from baseline cardiometabolic risk markers to three months
blood lipids, c-reactive proteins (CRP), blood glukos, HbA1c, Insulin-like growth factor (IGF-1), Interleukin-6 (Il-6)
from baseline cardiometabolic risk markers to three months
Heart and lung foundation stress test
Time Frame: at baseline
self-perceived stress
at baseline
Food frequency questionnaire
Time Frame: at baseline
self-reported food intake and quality
at baseline
Montreal outcome assessment (MoCA)
Time Frame: at baseline
cognition
at baseline
Modified rankin scale (MRS)
Time Frame: at baseline
motor function
at baseline
Mortality
Time Frame: from baseline to 1 year
register-based mortality
from baseline to 1 year
Health-related quality of life
Time Frame: from baseline to 1 year
register-based quality of life
from baseline to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala County Council, Sweden

Investigators

  • Principal Investigator: Birgit Vahlberg, Sweden,Uppsala Uppsala University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Anticipated)

March 1, 2018

Study Completion (Anticipated)

October 1, 2018

Study Registration Dates

First Submitted

September 11, 2016

First Submitted That Met QC Criteria

September 14, 2016

First Posted (Estimate)

September 15, 2016

Study Record Updates

Last Update Posted (Actual)

September 19, 2017

Last Update Submitted That Met QC Criteria

September 17, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UppsalaCC2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Stroke

Clinical Trials on Outdoor walking and strength exercise

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe