Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
Healthy Volunteers
NCT04576598

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

Led by University of Valencia · Updated on 2022-12-28

128

Participants Needed

2

Research Sites

362 weeks

Total Duration

On this page

Sponsors

U

University of Valencia

Lead Sponsor

G

Generalitat Valenciana

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 90Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Having stroke sequelae for at least 6 months
  • Living in the community for at least 2 months since the last stroke
  • Ability to walk around the house with or without technical aids without supervision (FACHS  2)
  • Sufficient cognitive capacity to give informed consent and answer questions
Not Eligible

You will not qualify if you...

  • No strength deficit in lower limbs or walking difficulties
  • Poor vital prognosis or other conditions that may affect study participation such as blindness, severe sensitivity alteration, or musculoskeletal or cardiovascular conditions contraindicating physical activity

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 2 locations

1

Department of Physiotherapy. University of Valencia

Valencia, Spain, 46010

Actively Recruiting

2

University of Valencia

Valencia, Spain, 46010

Actively Recruiting

Loading map...

Research Team

M

M.Luz Sánchez Sánchez, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here