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Effects of Aerobic Training Post-stroke

This study is currently recruiting participants.
Verified September 2017 by Christina Danielli Coelho de Morais Faria, Federal University of Minas Gerais
Sponsor:
ClinicalTrials.gov Identifier:
NCT02798237
First Posted: June 14, 2016
Last Update Posted: September 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Christina Danielli Coelho de Morais Faria, Federal University of Minas Gerais
  Purpose

Physical activity level is an important determinant of quality of life in persons post-stroke. There is a lack of knowledge regarding the effects of aerobic training on physical activity levels in subjects post-stroke. Therefore, the primary objective will be to investigate the effects of aerobic treadmill training on physical activity levels and sedentary behavior in subjects post-stroke. The secondary aim will be to investigate the effects of the training on cardiorespiratory fitness, endurance, depression, mobility, quality of life, and participation.

A randomized controlled trial with blinded assessment will assign eligible participants to either: 1) aerobic treadmill training (experimental group, at 60-80% of heart rate reserve), or 2) overground walking (control group, below 40% of heart rate reserve). Both groups will receive 40-minute training sessions three times/week over 12-weeks, in groups of 2-4 participants, by a trained physiotherapist. Primary outcomes: physical activity levels and sedentary behavior (Multisensor SenseWear Mini® and Human Activity Profile). Secondary outcomes: cardiorespiratory fitness (peak oxygen uptake (VO2peak) and ventilatory threshold), endurance, depression, mobility, quality of life, and participation. The effects of the trainings will be analyzed from the collected data and intention-to-treat analysis. Between-groups differences will be measured by two-way ANOVA with repeated measures considering the baseline, post-training, and a 4-week follow-up.

The results of this trial will likely provide valuable new information about the effects of aerobic treadmill training in improving physical activity levels and sedentary behavior, through changes in cardiorespiratory fitness, for individuals following stroke.


Condition Intervention Phase
Stroke Other: Aerobic treadmill training Other: Control (overground walking) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Aerobic Training on Physical Activity Levels and Sedentary Behavior in Subjects Post-stroke: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Christina Danielli Coelho de Morais Faria, Federal University of Minas Gerais:

Primary Outcome Measures:
  • Change from baseline in Physical activity levels - multisensor monitor [ Time Frame: At baseline, 12 weeks post-intervention, and at 4-week follow-up ]
    Physical activity levels will be assessed by a multisensor monitor (SenseWear®, BodyMedia, Pittsburgh, USA).

  • Change from baseline in Physical activity levels - Human Activity Profile [ Time Frame: At baseline, 12 weeks post-intervention, and at 4-week follow-up ]
    Physical activity levels will be assessed by Human Activity Profile

  • Change from baseline in sedentary behavior - multisensor monitor [ Time Frame: At baseline, 12 weeks post-intervention, and at 4-week follow-up ]
    Sedentary behavior will be assessed by a multisensor monitor (SenseWear®, BodyMedia, Pittsburgh, USA).


Secondary Outcome Measures:
  • Change from baseline in Cardiorespiratory fitness - cardiopulmonary exercise test [ Time Frame: At baseline, 12 weeks post-intervention, and at 4-week follow-up ]
    Cardiorespiratory fitness will be assessed by cardiopulmonary exercise test

  • Change from baseline in Endurance - six minute walk test [ Time Frame: At baseline, 12 weeks post-intervention, and at 4-week follow-up ]
    Endurance will be assessed by six minute walk test

  • Change from baseline in Endurance - shuttle walk test [ Time Frame: At baseline,12 weeks post-intervention, and at 4-week follow-up ]
    Endurance will be assessed by shuttle walk test

  • Change from baseline in Depression - Patient Health Questionnaire (PHQ-2 and PHQ-9) [ Time Frame: At baseline, 12 weeks post-intervention, and at 4-week follow-up ]
    Depression will be assessed by Patient Health Questionnaire (PHQ-2 and PHQ-9)

  • Change from baseline in Mobility - gait speed [ Time Frame: At baseline,12 weeks post-intervention, and at 4-week follow-up ]
    Mobility will be assessed by gait speed

  • Change from baseline in Quality of life - Stroke specific quality of life [ Time Frame: At baseline, 12 weeks post-intervention, and at 4-week follow-up ]
    Quality of life will be assessed by Stroke specific quality of life

  • Change from baseline in Participation - Stroke impact scale [ Time Frame: At baseline, 12 weeks post-intervention, and at 4-week follow-up ]
    Participation will be assessed by (Stroke impact scale)


Estimated Enrollment: 22
Actual Study Start Date: August 2, 2017
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aerobic treadmill training

Participants will receive three sessions per week over 12 weeks, in groups of 2-4 participants, by a trained physiotherapist. The duration of the sessions will be 40 minutes (5-10 minutes of warm-up/cool-down and 30 minutes of aerobic treadmill training at 60-80% of heart rate reserve). The training intensity progression will be individualized.

Before and after the training, participants will remain at rest for 10-15 minutes to measure heart rate, blood pressure and peripheral oxygen saturation (SpO2). The heart rate will be measured continuously during training. Participants will be asked to report any discomfort and to not volunteer to participate in other exercise program. Device: treadmill.

Other: Aerobic treadmill training

Participants will receive three sessions per week over 12 weeks, in groups of 2-4 participants, by a trained physiotherapist. The duration of the sessions will be 40 minutes (5-10 minutes of warm-up/cool-down and 30 minutes of aerobic treadmill training at 60-80% of heart rate reserve). The training intensity progression will be individualized.

Before and after the training, participants will remain at rest for 10-15 minutes to measure heart rate, blood pressure and peripheral oxygen saturation (SpO2). The heart rate will be measured continuously during training. Participants will be asked to report any discomfort and to not volunteer to participate in other exercise program. Device: treadmill.

Sham Comparator: Control (overground walking)
Participants will receive three sessions per week over 12 weeks, in groups of 2-4 participants, by a trained physiotherapist. The duration of the sessions will be 40 minutes (5-10 minutes of warm-up/cool-down and 30 minutes of comfortable walking below 40% of heart rate reserve). Before and after the training, participants will remain at rest for 10-15 minutes to measure heart rate, blood pressure and peripheral oxygen saturation (SpO2). The heart rate will be measured continuously. Participants will be asked to report any discomfort and to not volunteer to participate in other exercise program.
Other: Control (overground walking)
Participants will receive three sessions per week over 12 weeks, in groups of 2-4 participants, by a trained physiotherapist. The duration of the sessions will be 40 minutes (5-10 minutes of warm-up/cool-down and 30 minutes of comfortable walking below 40% of heart rate reserve). Before and after the exercise, participants will remain at rest for 10-15 minutes to measure heart rate, blood pressure and peripheral oxygen saturation (SpO2). The heart rate will be measured continuously. Participants will be asked to report any discomfort and to not volunteer to participate in other exercise program

Detailed Description:

The sample size has been calculated considering the physical activity levels measured by the Human Activity Profile (HAP). The effect size has been derived from the study of Teixeira-Salmela et al. 1999, who performed aerobic training in addition to lower limbs resistance training, and home exercises with subjects with chronic stroke. The experimental group (n=6) showed an increase on HAP on average of 20±6.1 points after the intervention, and the control group (n=7) had an average reduction of 1.86±0.19 points. Considering a significance level of 5% and a desired power of 80%, 9 participants per group was found, or 18 participants in total. Assuming an expected dropout rate of 20%, a target of 22 participants in total was set (11 participants per group).

Statistical analyses: A code will be given to each participant. Two independent examiners, blinded to the group allocation, will perform data entry, and verify missing or apparently wrong values. Original paper forms will be kept in a secure place. Electronic files will be available only to the research team. An independent examiner, blinded to the group allocation, will perform the statistical analysis by SPSS (SPSS Inc., Chicago, IL, USA). Descriptive statistics will be performed for all outcome variables. Baseline variables will be compared between groups using independent Student's t-tests, to investigate differences among the groups regarding the clinical-demographical characteristics. If differences between the groups at baseline exist, analysis of covariance will be used to eliminate the influence of extraneous factors. The effects of the interventions will be analyzed from the collected data and the intention-to-treat analysis. Data from the last available assessment will be considered as the values of missed sessions. Between-groups differences will be measured with two-way ANOVA with repeated measures considering the baseline, post-training, and follow-up measures. Level of significance will be set at 0.05 and adjusted for multiple comparisons. Normality and equality of variance will also be analyzed to ensure correct use of parametric data. Study results will be spread regardless of the magnitude and direction of the effects.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥ 20years of age;
  • diagnosis of stroke (>6months);
  • sedentary or insufficiently active;
  • have a writing medical permission to participate in the training program.

Exclusion Criteria:

  • cognitive impairment (Mini-Mental Status Examination score: illiterate 13 points; elementary and middle school 18 points; and high-school 26 points; or inability to respond to verbal command);
  • inability to walk independently for at least 10 minutes, with or without walking devices;
  • pain or other disorders precluding their participation.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02798237


Contacts
Contact: Christina Faria, Ph.D. 55-31-3409-4783 cdcmf@ufmg.br

Locations
Brazil
Universidade Federal de Minas Gerais Recruiting
Belo Horizonte, Minas Gerais, Brazil
Contact: Christina Faria    55-31-3409-4783    cdcmf@ufmg.br   
Sponsors and Collaborators
Federal University of Minas Gerais
Investigators
Principal Investigator: Christina Faria, Ph.D. Federal University of Minas Gerais
  More Information

Publications:
Responsible Party: Christina Danielli Coelho de Morais Faria, Doctor, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT02798237     History of Changes
Other Study ID Numbers: CAAE:51454115.6.0000.5149
First Submitted: June 6, 2016
First Posted: June 14, 2016
Last Update Posted: September 6, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Christina Danielli Coelho de Morais Faria, Federal University of Minas Gerais:
exercise
walking
health

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