Sedentarism of Stroke Survivors in the Valencian Community and Development of a Self-management Program

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorUniversity of Valencia

About this trial

Stroke is the third leading cause of disability worldwide. Women present a higher incidence of this pathology and prevalence of its risk factors. Similarly, after stroke, women have a poorer functional outcome, higher rates of institutionalization and greater dependence on activities of daily living. People who have suffered a stroke are at increased risk of cardiovascular disease, with an estimated one-third of stroke survivors suffering a new event in the following 5 years. Current scientific literature recommends the promotion of physical activity (PA) and exercise for the prevention of stroke and its sequelae. However, stroke survivors are often insufficiently active. Therefore, changing their behavior with respect to PA and sedentary lifestyle is fundamental. Moreover, gender perspective, should also taken into account.

Thus, our aims are to study whether there are differences in women with chronic stroke sequelae compared to men in: 1) the amount of sitting time and its context, as well as the time spent in different intensities of PA; 2) the reduction of sitting time and its effect on health after the completion of the PA self-management program and sedentary lifestyle developed in this project; 3) the presence of sarcopenia, osteoporosis and the state of frailty.

To achieve these objectives, the lifestyle habits of 128 subjects (64 women) who live in the community and have chronic sequelae of stroke (≥ 6 months) will be evaluated. In addition, possible differences in the study variables will be verified with control people without sequelae of stroke. Moreover, in order to reduce the risks of stroke survivors, a program of self-management of PA and sedentary lifestyle will be developed. This program will be carried out through several sessions spread over six months that will incorporate: education, goal setting, identification of barriers, self-control and feedback. The feasibility of this intervention will be determined by examining compliance, duration, utility, and safety. At least 64 of the previously studied subjects will participate in this program, analyzing whether it favors the reduction of sitting time and its effect on health thanks to the measurement of different physical capacities. The differences between men and women in response to the program will be determined. Finally, we will explore whether the effect of the program is greater when it is implemented in the subacute than in the chronic phase.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

having sequelae after stroke of at least 6 months of evolution

being community-dwelling (minimum 2 months since the last stroke)

having the ability to walk around the house with or without technical aids but without requiring supervision from another person (FACHS ≥ 2)

having enough cognitive capacity to provide informed consent and to understand and answer the questions proposed

Disqualifiers

not having a strength deficit in the lower limbs or walking difficulties

having poor vital prognosis or suffering from other pathologies or disorders that may alter the development of the study (blindness, severe sensitivity alteration, musculoskeletal or cardiovascular conditions that contraindicate the performance of physical activity...)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Self-management program to increase physical activity levels

    Other intervention

    Information and Communication Technologies will be used to carry out various remote sessions. The sessions will address important issues to promote self-management of sedentary lifestyle by stroke survivors. Additionally, a peer support group will be created in order to improve adherence to the program.

  • Education information

    Other intervention

    Education on the importance of active lifestyle habits post-stroke.

Treatment groups

128 Participants
are divided into 2 treatment groups
Group A: Self-management group to increase physical activity levelsExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from Baseline Physical activity level at a year

International Physical Activity Questionnaire (IPAQ)

Time frame
1 year
2

Change from Baseline Sedentary time at a year

ActiGraph wGT3X-BT accelerometers

Time frame
1 year

Secondary outcomes

1

Change from Baseline Functional Mobility at a year

Timed Up and Go Test

Time frame
1 year
2

Change from Baseline Lower extremity functioning at a year

Short Physical Performance Battery (SPPB)

Time frame
1 year
3

Change from Baseline Postural stability in standing at a year

Posturography with the Wii Balance Board

Time frame
1 year
4

Change from Baseline Frailty at a year

Fried's frailty phenotype

Time frame
1 year

Other outcomes

Sponsors and contacts

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University of Valencia

Lead sponsor

Generalitat Valenciana

Collaborator