Effects of Aerobic Training Post-stroke

NCT02798237 | Completed Phase 4

• 1 other identifier: CAAE:51454115.6.0000.5149
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Keywords

exercise; walking; health

Outcome Measures

Primary Outcomes (3)

• Change from baseline in Physical activity levels - multisensor monitor

  Physical activity levels will be assessed by a multisensor monitor (SenseWear®, BodyMedia, Pittsburgh, USA).

  At baseline, 12 weeks post-intervention, and at 4-week follow-up

• Change from baseline in Physical activity levels - Human Activity Profile

  Physical activity levels will be assessed by Human Activity Profile

  At baseline, 12 weeks post-intervention, and at 4-week follow-up

• Change from baseline in sedentary behavior - multisensor monitor

  Sedentary behavior will be assessed by a multisensor monitor (SenseWear®, BodyMedia, Pittsburgh, USA).

  At baseline, 12 weeks post-intervention, and at 4-week follow-up

Secondary Outcomes (7)

• Change from baseline in Cardiorespiratory fitness - cardiopulmonary exercise test

  At baseline, 12 weeks post-intervention, and at 4-week follow-up

• Change from baseline in Endurance - six minute walk test

  At baseline, 12 weeks post-intervention, and at 4-week follow-up

• Change from baseline in Endurance - shuttle walk test

  At baseline,12 weeks post-intervention, and at 4-week follow-up

• Change from baseline in Depression - Patient Health Questionnaire (PHQ-2 and PHQ-9)

  At baseline, 12 weeks post-intervention, and at 4-week follow-up

• Change from baseline in Mobility - gait speed

  At baseline,12 weeks post-intervention, and at 4-week follow-up

Study Arms (2)

Aerobic treadmill training

EXPERIMENTAL

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

Control (overground walking)

SHAM COMPARATOR

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)

Interventions

Aerobic treadmill training OTHER

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.

Aerobic treadmill training

Control (overground walking) OTHER

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

Control (overground walking)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Study Sites (1)

Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Location

Related Publications (4)

• Pang MY, Charlesworth SA, Lau RW, Chung RC. Using aerobic exercise to improve health outcomes and quality of life in stroke: evidence-based exercise prescription recommendations. Cerebrovasc Dis. 2013;35(1):7-22. doi: 10.1159/000346075. Epub 2013 Feb 14.

  PMID: 23428993 BACKGROUND

• Billinger SA, Arena R, Bernhardt J, Eng JJ, Franklin BA, Johnson CM, MacKay-Lyons M, Macko RF, Mead GE, Roth EJ, Shaughnessy M, Tang A; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Lifestyle and Cardiometabolic Health; Council on Epidemiology and Prevention; Council on Clinical Cardiology. Physical activity and exercise recommendations for stroke survivors: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 Aug;45(8):2532-53. doi: 10.1161/STR.0000000000000022. Epub 2014 May 20.

  PMID: 24846875 BACKGROUND

• 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: 34184251 DERIVED

• Aguiar LT, Nadeau S, Britto RR, Teixeira-Salmela LF, Martins JC, Faria CDCM. Effects of aerobic training on physical activity in people with stroke: protocol for a randomized controlled trial. Trials. 2018 Aug 17;19(1):446. doi: 10.1186/s13063-018-2823-0.

  PMID: 30119697 DERIVED

MeSH Terms

Conditions

Stroke; Motor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Christina Faria, Ph.D.

  Federal University of Minas Gerais

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 6, 2016
• First Posted: June 14, 2016
• Study Start: December 4, 2017
• Primary Completion: October 15, 2018
• Study Completion: October 15, 2018
• Last Updated: May 15, 2019

Record last verified: 2019-05

Locations

BR (1)