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

Primary Purpose

Stroke Sequelae

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Self-management program to increase physical activity levels
Education information
Sponsored by
University of Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke Sequelae

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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...)

Sites / Locations

  • Department of Physiotherapy. University of ValenciaRecruiting
  • University of ValenciaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Self-management group to increase physical activity levels

Control group

Arm Description

This group will perform a self-management program along 6 months. This program will aim to increase the level of physical activity and adherence to healthier lifestyle habits and will be carried out through several sessions that will incorporate: education, goal setting, identification of barriers, self-control and feedback.

This group will participate in the initial educational session and will be given a leaflet with recommendations for physical activity to follow throughout the six months.

Outcomes

Primary Outcome Measures

Change from Baseline Physical activity level at a year
International Physical Activity Questionnaire (IPAQ)
Change from Baseline Sedentary time at a year
ActiGraph wGT3X-BT accelerometers

Secondary Outcome Measures

Change from Baseline Functional Mobility at a year
Timed Up and Go Test
Change from Baseline Lower extremity functioning at a year
Short Physical Performance Battery (SPPB)
Change from Baseline Postural stability in standing at a year
Posturography with the Wii Balance Board
Change from Baseline Frailty at a year
Fried's frailty phenotype
Change from Baseline Sarcopenia at a year
Bioimpedance with Tanita BC-418MA
Change from Baseline Bone mineral density at a year
Ultrasound bone densitometry with Sonost3000
Change from Baseline Motion analysis at a year
Inertial sensors based motion capture system Xsens-DOT

Full Information

First Posted
September 10, 2020
Last Updated
December 26, 2022
Sponsor
University of Valencia
Collaborators
Generalitat Valenciana
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1. Study Identification

Unique Protocol Identification Number
NCT04576598
Brief Title
Sedentarism of Stroke Survivors in the Valencian Community and Development of a Self-management Program
Acronym
SEDMA_Stroke
Official Title
Assessment of the Level of Physical Activity and Sedentarism of Stroke Survivors in the Valencian Community and Development of a Specific Self-management Program
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2020 (Actual)
Primary Completion Date
December 20, 2025 (Anticipated)
Study Completion Date
December 20, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia
Collaborators
Generalitat Valenciana

4. Oversight

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

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Sequelae

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Self-management group to increase physical activity levels
Arm Type
Experimental
Arm Description
This group will perform a self-management program along 6 months. This program will aim to increase the level of physical activity and adherence to healthier lifestyle habits and will be carried out through several sessions that will incorporate: education, goal setting, identification of barriers, self-control and feedback.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
This group will participate in the initial educational session and will be given a leaflet with recommendations for physical activity to follow throughout the six months.
Intervention Type
Other
Intervention Name(s)
Self-management program to increase physical activity levels
Other Intervention Name(s)
Physiotherapy, Physical therapy, Physical exercise program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Education information
Intervention Description
Education on the importance of active lifestyle habits post-stroke.
Primary Outcome Measure Information:
Title
Change from Baseline Physical activity level at a year
Description
International Physical Activity Questionnaire (IPAQ)
Time Frame
1 year
Title
Change from Baseline Sedentary time at a year
Description
ActiGraph wGT3X-BT accelerometers
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Change from Baseline Functional Mobility at a year
Description
Timed Up and Go Test
Time Frame
1 year
Title
Change from Baseline Lower extremity functioning at a year
Description
Short Physical Performance Battery (SPPB)
Time Frame
1 year
Title
Change from Baseline Postural stability in standing at a year
Description
Posturography with the Wii Balance Board
Time Frame
1 year
Title
Change from Baseline Frailty at a year
Description
Fried's frailty phenotype
Time Frame
1 year
Title
Change from Baseline Sarcopenia at a year
Description
Bioimpedance with Tanita BC-418MA
Time Frame
1 year
Title
Change from Baseline Bone mineral density at a year
Description
Ultrasound bone densitometry with Sonost3000
Time Frame
1 year
Title
Change from Baseline Motion analysis at a year
Description
Inertial sensors based motion capture system Xsens-DOT
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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...)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
M.Luz Sánchez Sánchez, PhD
Phone
0034963983853
Email
M.Luz.Sanchez@uv.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M.Luz Sánchez Sánchez, PhD
Organizational Affiliation
University of Valencia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physiotherapy. University of Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M.Luz Sánchez-Sánchez, PhD
Phone
0034963983853
Email
M.Luz.Sanchez@uv.es
First Name & Middle Initial & Last Name & Degree
M.Arantzazu Ruescas-Nicolau, PhD
First Name & Middle Initial & Last Name & Degree
Sofia Pérez-Alenda, PhD
First Name & Middle Initial & Last Name & Degree
Gemma V. Espí-López, PhD
Facility Name
University of Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sánchez-Sánchez ML
Phone
0034-963 98 38 55
Email
M.Luz.Sanchez@uv.es
First Name & Middle Initial & Last Name & Degree
Ruescas-Nicolau A
Phone
0034-963 98 38 55
Email
Arancha.Ruescas@uv.es

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24505342
Citation
Veerbeek JM, van Wegen E, van Peppen R, van der Wees PJ, Hendriks E, Rietberg M, Kwakkel G. What is the evidence for physical therapy poststroke? A systematic review and meta-analysis. PLoS One. 2014 Feb 4;9(2):e87987. doi: 10.1371/journal.pone.0087987. eCollection 2014.
Results Reference
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24352519
Citation
Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Judd SE, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Mackey RH, Magid DJ, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Mussolino ME, Neumar RW, Nichol G, Pandey DK, Paynter NP, Reeves MJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2014 update: a report from the American Heart Association. Circulation. 2014 Jan 21;129(3):e28-e292. doi: 10.1161/01.cir.0000441139.02102.80. Epub 2013 Dec 18. No abstract available.
Results Reference
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PubMed Identifier
30051462
Citation
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Results Reference
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PubMed Identifier
25747877
Citation
Howe MD, McCullough LD. Prevention and management of stroke in women. Expert Rev Cardiovasc Ther. 2015 Apr;13(4):403-15. doi: 10.1586/14779072.2015.1020300. Epub 2015 Mar 6.
Results Reference
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PubMed Identifier
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Citation
Bushnell CD, Reeves MJ, Zhao X, Pan W, Prvu-Bettger J, Zimmer L, Olson D, Peterson E. Sex differences in quality of life after ischemic stroke. Neurology. 2014 Mar 18;82(11):922-31. doi: 10.1212/WNL.0000000000000208. Epub 2014 Feb 7.
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PubMed Identifier
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Citation
Mackie P, Weerasekara I, Crowfoot G, Janssen H, Holliday E, Dunstan D, English C. What is the effect of interrupting prolonged sitting with frequent bouts of physical activity or standing on first or recurrent stroke risk factors? A scoping review. PLoS One. 2019 Jun 13;14(6):e0217981. doi: 10.1371/journal.pone.0217981. eCollection 2019.
Results Reference
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PubMed Identifier
15105522
Citation
Gordon NF, Gulanick M, Costa F, Fletcher G, Franklin BA, Roth EJ, Shephard T; American Heart Association Council on Clinical Cardiology, Subcommittee on Exercise, Cardiac Rehabilitation, and Prevention; the Council on Cardiovascular Nursing; the Council on Nutrition, Physical Activity, and Metabolism; and the Stroke Council. Physical activity and exercise recommendations for stroke survivors: an American Heart Association scientific statement from the Council on Clinical Cardiology, Subcommittee on Exercise, Cardiac Rehabilitation, and Prevention; the Council on Cardiovascular Nursing; the Council on Nutrition, Physical Activity, and Metabolism; and the Stroke Council. Stroke. 2004 May;35(5):1230-40. doi: 10.1161/01.STR.0000127303.19261.19. No abstract available.
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Citation
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Citation
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Sedentarism of Stroke Survivors in the Valencian Community and Development of a Self-management Program

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