Vivifrail Program on the Degree of Debilitation in Hospitalized Patients After Venous Hemolysis in Acute Ischemic Stroke
NCT ID: NCT06391502
Last Updated: 2024-06-03
Study Results
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Basic Information
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RECRUITING
NA
2 participants
INTERVENTIONAL
2024-08-01
2025-07-01
Brief Summary
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Detailed Description
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In addition, exercise can reduce the damage caused by acute illness and hospitalization.Even so, it has not been established whether exercise therapy affects the degree of weakness or whether weakness affects response to treatment.
While frailty is not a disease, it can affect the presentation of many age-related diseases and the response to treatment.For example, after a short period of strength exercise in frail elderly people, autophagy in muscle cells is activated, affecting the overall health of the muscles and thus the ability to move.Similarly, the inflammatory response increases after vigorous aerobic exercise.It was also less clear whether individuals with higher frailty had any response to the intervention.
Multi-Component Exercise（Vivifrail） is an innovative multi-component exercise program that includes strength training, endurance training, balance training, and flexibility training to improve the exerciser's gait, balance, and cardiorespiratory function by increasing muscle mass, strength, and endurance.Recent studies have shown that it is one of the best ways to improve patients' gait, balance, cardiopulmonary function and cognitive executive function, as well as the best way to treat frailty, and can reduce the risk of falls and delay cognitive decline in elderly hospitalized patients with neurocognitive disorders.
The objective of this study was to examine the effect of exercise intervention on the level of frailty in older adults admitted for venous hemolysis for acute ischemic stroke.The effects of baseline frailty levels on the intervention, effectiveness of frailty, changes in Physical function (Modified Barthel Index (MBI), Short Physical Performance Battery (SPPB), and other health outcomes were determined.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Routine exercise group
The routine exercise care group, that is, the control group, will complete the routine exercise care of patients with acute ischemic stroke after venous hemolytic surgery in accordance with the hospital regulations: From 24 hours after surgery, patients with mild and moderate stroke can be turned over in bed (once every 2 hours), ankle pump exercise (three times a day), and transitional bedside rehabilitation exercise (such as walking around the bed, etc.) after no discomfort.
No interventions assigned to this group
Multicomponent exercise group
Select the corresponding intervention according to the SPPB score:0-3 scores (Plan A) :1. Walking 2.Relax your hand 3.Lift a bottle 4.Leg extensions with an ankle weight 5.Getting up from a chair with help 6.Holding onto the person who helps you 7.Arm stretching 4-6 scores(Plan B):1. Walking 2.Lift a bottle 3.Squeeze a ball 4.pretend to sit 5.Walking on tip toes and heels 6.Arm stretching in a chair 7.Stretch your arms up with your hands clasped;7-9 scores(Plan C):1.Walking 2.Roll-up a small towel 3.Take two plastic bottles filled with 500ml of water 4.Getting up from a chair 5.Walking over obstacles 6.Walking in a figure of eight 7.Leg stretching sit in a chair 8.Arm stretching;10-12 scores( Plan D):1.Walking 2.Twist a towel 3.Lift a bottle 4.Getting up from a chair 5.Going up and down stairs 6.Walking in a figure of eight 7.Walking while touching a balloon 8.Arm stretching;See details at http://vivifrail.com/
Multi-component Exercise Intervention Program
The Vivifrail program (http://vivifrail.com) is a home-based exercise program that focuses on personalized multi-component exercise prescriptions based on an elderly person's functional abilities, including resistance/strength, balance, flexibility, and cardiovascular endurance exercise (i.e., walking).
During hospitalization, patients who meet the criteria of sodium intake will be screened, and then divided into groups according to the method of randomized controlled trial. The experimental group will carry out corresponding exercise plan according to the results of SPPB.
Interventions
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Multi-component Exercise Intervention Program
The Vivifrail program (http://vivifrail.com) is a home-based exercise program that focuses on personalized multi-component exercise prescriptions based on an elderly person's functional abilities, including resistance/strength, balance, flexibility, and cardiovascular endurance exercise (i.e., walking).
During hospitalization, patients who meet the criteria of sodium intake will be screened, and then divided into groups according to the method of randomized controlled trial. The experimental group will carry out corresponding exercise plan according to the results of SPPB.
Eligibility Criteria
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Inclusion Criteria
2. Hospitalized patients diagnosed with ischemic stroke;
3. barthel index ≥60;
4. Muscle strength of both upper and lower limbs is above grade 3;
5. The pre-frailty and frailty state of the modified 5 Frailty Index (mFI-5) standard;
6. Patients willing to cooperate and sign informed consent
Exclusion Criteria
2. severe cognitive impairment, or severe dementia;
3. unable or unwilling to cooperate, any other unstable medical condition, or conditions that would prevent physical activity
65 Years
ALL
Yes
Sponsors
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Affiliated Hospital of Nantong University
OTHER
Responsible Party
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Principal Investigators
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xuemei zhang, master
Role: STUDY_CHAIR
Affiliated Hospital of Nantong University
Locations
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AHNantongU
Nantong, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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References
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Martinez-Velilla N, Casas-Herrero A, Zambom-Ferraresi F, Saez de Asteasu ML, Lucia A, Galbete A, Garcia-Baztan A, Alonso-Renedo J, Gonzalez-Glaria B, Gonzalo-Lazaro M, Apezteguia Iraizoz I, Gutierrez-Valencia M, Rodriguez-Manas L, Izquierdo M. Effect of Exercise Intervention on Functional Decline in Very Elderly Patients During Acute Hospitalization: A Randomized Clinical Trial. JAMA Intern Med. 2019 Jan 1;179(1):28-36. doi: 10.1001/jamainternmed.2018.4869.
Casas-Herrero A, Saez de Asteasu ML, Anton-Rodrigo I, Sanchez-Sanchez JL, Montero-Odasso M, Marin-Epelde I, Ramon-Espinoza F, Zambom-Ferraresi F, Petidier-Torregrosa R, Elexpuru-Estomba J, Alvarez-Bustos A, Galbete A, Martinez-Velilla N, Izquierdo M. Effects of Vivifrail multicomponent intervention on functional capacity: a multicentre, randomized controlled trial. J Cachexia Sarcopenia Muscle. 2022 Apr;13(2):884-893. doi: 10.1002/jcsm.12925. Epub 2022 Feb 11.
Perez-Zepeda MU, Martinez-Velilla N, Kehler DS, Izquierdo M, Rockwood K, Theou O. The impact of an exercise intervention on frailty levels in hospitalised older adults: secondary analysis of a randomised controlled trial. Age Ageing. 2022 Feb 2;51(2):afac028. doi: 10.1093/ageing/afac028.
Martinez-Velilla N, Casas-Herrero A, Zambom-Ferraresi F, Suarez N, Alonso-Renedo J, Contin KC, de Asteasu ML, Echeverria NF, Lazaro MG, Izquierdo M. Functional and cognitive impairment prevention through early physical activity for geriatric hospitalized patients: study protocol for a randomized controlled trial. BMC Geriatr. 2015 Sep 15;15:112. doi: 10.1186/s12877-015-0109-x.
Casas-Herrero A, Anton-Rodrigo I, Zambom-Ferraresi F, Saez de Asteasu ML, Martinez-Velilla N, Elexpuru-Estomba J, Marin-Epelde I, Ramon-Espinoza F, Petidier-Torregrosa R, Sanchez-Sanchez JL, Ibanez B, Izquierdo M. Effect of a multicomponent exercise programme (VIVIFRAIL) on functional capacity in frail community elders with cognitive decline: study protocol for a randomized multicentre control trial. Trials. 2019 Jun 17;20(1):362. doi: 10.1186/s13063-019-3426-0.
Carli F, Bousquet-Dion G, Awasthi R, Elsherbini N, Liberman S, Boutros M, Stein B, Charlebois P, Ghitulescu G, Morin N, Jagoe T, Scheede-Bergdahl C, Minnella EM, Fiore JF Jr. Effect of Multimodal Prehabilitation vs Postoperative Rehabilitation on 30-Day Postoperative Complications for Frail Patients Undergoing Resection of Colorectal Cancer: A Randomized Clinical Trial. JAMA Surg. 2020 Mar 1;155(3):233-242. doi: 10.1001/jamasurg.2019.5474.
Izquierdo M. [Multicomponent physical exercise program: Vivifrail]. Nutr Hosp. 2019 Jul 1;36(Spec No2):50-56. doi: 10.20960/nh.02680. Spanish.
Sanchez-Sanchez JL, de Souto Barreto P, Anton-Rodrigo I, Ramon-Espinoza F, Marin-Epelde I, Sanchez-Latorre M, Moral-Cuesta D, Casas-Herrero A. Effects of a 12-week Vivifrail exercise program on intrinsic capacity among frail cognitively impaired community-dwelling older adults: secondary analysis of a multicentre randomised clinical trial. Age Ageing. 2022 Dec 5;51(12):afac303. doi: 10.1093/ageing/afac303.
Courel-Ibanez J, Pallares JG, Garcia-Conesa S, Buendia-Romero A, Martinez-Cava A, Izquierdo M. Supervised Exercise (Vivifrail) Protects Institutionalized Older Adults Against Severe Functional Decline After 14 Weeks of COVID Confinement. J Am Med Dir Assoc. 2021 Jan;22(1):217-219.e2. doi: 10.1016/j.jamda.2020.11.007. Epub 2020 Dec 6. No abstract available.
Izquierdo M, Rodriguez-Manas L, Sinclair AJ. Editorial: What Is New in Exercise Regimes for Frail Older People - How Does the Erasmus Vivifrail Project Take Us Forward? J Nutr Health Aging. 2016;20(7):736-7. doi: 10.1007/s12603-016-0702-5. No abstract available.
Sanchez-Sanchez JL, Udina C, Medina-Rincon A, Esbri-Victor M, Bartolome-Martin I, Moral-Cuesta D, Marin-Epelde I, Ramon-Espinoza F, Latorre MS, Idoate F, Goni-Sarries A, Martinez-Martinez B, Bonet RE, Librero J, Casas-Herrero A. Effect of a multicomponent exercise program and cognitive stimulation (VIVIFRAIL-COGN) on falls in frail community older persons with high risk of falls: study protocol for a randomized multicenter control trial. BMC Geriatr. 2022 Jul 23;22(1):612. doi: 10.1186/s12877-022-03214-0.
Other Identifiers
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zhangxuemei
Identifier Type: -
Identifier Source: org_study_id
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