Efficacy of Task-specific Training on Physical Activity Levels Post-stroke

NCT02937480 | Completed

• 1 other identifier: CAAE: 51453915.1.0000.5149
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The majority of people after stroke demonstrate mobility limitations, which may reduce their physical activity levels. Task-specific training has shown to be an effective intervention to improve mobility in individuals with stroke, however, little is known about the impact of this intervention on levels of physical activity. The main objective will be to investigate the efficacy of a task-specific training, focused on both upper and lower limbs, in improving physical activity levels and mobility in individuals with stroke. The secondary objective will be to investigate the effect of the training, in improving muscle strength, exercise capacity, and quality of life. A randomized controlled trial with blinded assessment will assign eligible participants to either: 1) experimental group or 2) control group. Participants will receive interventions three times per week over 12 weeks. The experimental group will undertake task-specific training, while the control group will undertake global stretching and memory exercises, and health education sessions. Primary outcomes will include measures of physical activity levels and mobility, whereas secondary outcomes will be muscle strength, exercise capacity, and quality of life. The outcomes will be measured at baseline, 12 weeks post-intervention, and four and 12 weeks follow-up. The findings of this trial have the potential to provide important insights regarding the effects of task-specific training, focused on both upper and lower limbs, in preventing secondary post-stroke complications and improving the participants' general health through changes in physical activity levels.

Conditions

Stroke

Keywords

stroke; physical activity; task performance; clinical protocol

Outcome Measures

Primary Outcomes (4)

• Change from baseline in Physical activity levels - physical activity monitor

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

  At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up

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

  Physical activity levels will be assessed by Human Activity Profile.

  At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up

• Change from baseline in Mobility - Gait speed

  Mobility will be assessed by gait speed.

  At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up

• Change from baseline in Mobility - TEMPA

  Mobility will be assessed by TEMPA test.

  At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up

Secondary Outcomes (3)

• Change from baseline in Muscle strength

  At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up

• Change from baseline in Exercise capacity

  At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up

• Change from baseline in Quality of life

  At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up

Study Arms (2)

Experimental group

EXPERIMENTAL

Task-specific training

Other: Task-specific training

Control group

SHAM COMPARATOR

Global stretching, memory exercises, health care orientation

Other: Global stretching, memory exercises, health care orientation

Interventions

Task-specific training OTHER

The task-specific training will be composed by 30 minutes for upper limb and 30 minutes for lower limb tasks. Subjects will performed five minutes of exercise in each station of the circuit and only the last station will last 10 minutes and will involve a walking training with auditory stimulation. Individuals will be encouraged to work as hard as possible at each station and verbal feedback and instructions aimed at improving performance will be taken. Between each task, the participants will be allowed to rest for at least 1-2 minutes, and individual adjustments will be carried out for better adaptations to the training.

Also known as: Task-oriented training

Experimental group

Global stretching, memory exercises, health care orientation OTHER

The control intervention will be composed by 40 minutes for global stretching, 20 minutes of memory exercises and health care orientation

Control group

Eligibility Criteria

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

You may qualify if:

• have a clinical diagnosis of first or recurrent stroke more than six months since the onset of their strokes;
• are older than 19 years of age;
• are able to independently walk 10 m with or without walking aid devices;
• have tone of elbow flexor muscles below 4 on modified Ashworth scale;
• are inactive or insufficient, based on Centers for Disease Control and Prevention criteria;
• get medical permission for physical activity practice

You may not qualify if:

• have severe cognitive deficits, as assessed by the mini-mental state exam and/or language problems (comprehensive afasia), as evaluated by simple motor commands ("lift your nonparetic upper limb and open your hand"), which might prevent them from following instructions during the data collection and/or the interventions;
• have history of severe heart disease and/or uncontrolled blood pressure;
• have pain and/or other adverse health conditions which might affect the performance in the intervention program, such as vestibular disturbances, severe arthritis, or other neurological disorders.

Sponsors & Collaborators

• Federal University of Minas Gerais: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• Fundação de Amparo à Pesquisa do estado de Minas Gerais: collaborator

Study Sites (1)

Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, 31270-901, Brazil

Location

Related Publications (28)

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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 Danielli CM Faria, Doctor

  Federal University of Minas Gerais

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• 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: September 18, 2016
• First Posted: October 18, 2016
• Study Start: June 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: December 17, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)