Clinical trial NCT06391502: Vivifrail Program on the Degree of Debilitation in Hospitalized Patients After Venous Hemolysis in Acute Ischemic Stroke
Official title: Effect of Multi-component Exercise Intervention Program on the Degree of Frailty in Hospitalized Patients After Venous Hemolysis in Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ischemic Stroke
Exercise Therapy
Frailty
Lead sponsor: Affiliated Hospital of Nantong University
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 2
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Physical exercise is an effective strategy to maintain functional ability and improve debilitating symptoms in the elderly.In addition to functional enhancement, exercise is considered a cornerstone for enhancing cognitive function in debilitated older adults with cognitive impairment and dementia.The investigators evaluated the effect of the Vivifrail exercise intervention on the degree of debilitation in elderly hospitalized patients after venous hemolysis in acute ischemic stroke

Detailed description: Elderly patients who are acutely hospitalized, including those who are able to walk independently, spend most of their stay in bed.In addition to worsening their functional status leading to significant muscle wasting and the development of other symptoms, it also increases the risk of cognitive decline and dementia in older adults, which is more pronounced in patients with acute ischemic stroke after venous hemolysis, and increases awareness of the need to replace prolonged bed rest with physical activity or exercise.Because there is evidence that this therapy during hospitalization is effective;A large number of studies have shown that rehabilitation training for AIS patients within 24 hours of onset is beneficial food.

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.

Eligibility criteria: Inclusion Criteria:

1. Over 65 years of age;
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:

1. fracture (within three months),
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

Primary outcomes:
measure: Short Physical Performance Battery（SPPB）
timeFrame: This outcome measure will be assessed within the first 2 days（Day 2） and at 1 month（Month 1） after intravenous thrombolysis in acute ischemic stroke.
measure: Modified Barthel Index
timeFrame: This outcome measure will be assessed within the first 2 days（Day 2） and at 1 month（Month 1） after intravenous thrombolysis in acute ischemic stroke.
measure: FRAIL Scale
timeFrame: This outcome measure will be assessed within the first 2 days（Day 2） and at 1 month（Month 1） after intravenous thrombolysis in acute ischemic stroke.
measure: Grip
timeFrame: This outcome measure will be assessed within the first 2 days（Day 2） and at 1 month（Month 1） after intravenous thrombolysis in acute ischemic stroke.
Secondary outcomes:
measure: Patient Health Questionaire - 9 items，PHQ -9
timeFrame: This outcome measure will be assessed within the first 2 days（Day 2） and at 1 month（Month 1） after intravenous thrombolysis in acute ischemic stroke.
measure: HendrichⅡfall risk model,HFRM
timeFrame: Acute ischemic stroke was evaluated within 48h of intravenous thrombolysis up to 4 weeks.
Other outcomes:
Locations:
city: Nantong
country: China
facility: AHNantongU
state: Jiangsu
Study officials:
affiliation: Affiliated Hospital of Nantong University
name: xuemei zhang, master
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Izquierdo M. [Multicomponent physical exercise program: Vivifrail]. Nutr Hosp. 2019 Jul 1;36(Spec No2):50-56. doi: 10.20960/nh.02680. Spanish.
citation: 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.
citation: 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.
citation: 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.
citation: 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.