Ischemic StrokeNCT06391502
Vivifrail Program on the Degree of Debilitation in Hospitalized Patients After Venous Hemolysis in Acute Ischemic Stroke
A study testing Multi-component Exercise Intervention Program in people with Ischemic Stroke and Exercise Therapy, run by Affiliated Hospital of Nantong University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ischemic Stroke, Exercise Therapy, Frailty
- What is being tested?
- Multi-component Exercise Intervention Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Over 65 years of age;
- Hospitalized patients diagnosed with ischemic stroke;
- barthel index ≥60;
- Muscle strength of both upper and lower limbs is above grade 3;
- The pre-frailty and frailty state of the modified 5 Frailty Index (mFI-5) standard;
- Patients willing to cooperate and sign informed consent
Who cannot join
- fracture (within three months),
- severe cognitive impairment, or severe dementia;
- unable or unwilling to cooperate, any other unstable medical condition, or conditions that would prevent physical activity
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
AHNantongU
Nantong, Jiangsu, 226000
zhang xuemei yan songshuang, 15896269868, 2557989983@qq.com
About this study
Official title: Effect of Multi-component Exercise Intervention Program on the Degree of Frailty in Hospitalized Patients After Venous Hemolysis in Acute Ischemic Stroke
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
Read the 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.
- Conditions
- Ischemic Stroke, Exercise Therapy, Frailty
- Being tested
- Multi-component Exercise Intervention Program
- Medical subject headings
- Ischemic Stroke, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-component Exercise Intervention ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Routine exercise group | No intervention | 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. |
| Multicomponent exercise group | Experimental | 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/ Receives: Behavioral: Multi-component Exercise Intervention Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Physical Performance Battery（SPPB）
The SPPB test to determine the level of frailty is a composite of the following three separate measures:
- - Balance test.
- - Walking speed test over 4 meters.
- - Test of getting up from a chair. Add the points of the SPPB test (1 to 3) to determine the grade.
- If due to limitations, you have not performed the SPPB test and you have elected to use the 6-meter walking test, the following values will be used to recommend the physical exercise program. Points 0-3 scores are considered as disability and given program A intervention; A score of 4-6 is considered as the early stage of asthenia and B intervention program is given; A score of 7-9 was considered as weak and C intervention program was given; A score of 10-12 is considered as healthy people and D intervention program is given
Measured: 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.
Modified Barthel Index
The assessment of the individual's daily living ability includes 10 items, including eating, decoration, bathing, etc. Each index is divided into 5 levels: complete dependence, greater dependence, medium dependence, lesser dependence, and independence. The higher the score, the better the independence of daily life, a total of 100 points
Measured: 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.
FRAIL Scale
Including fatigue, can not go up a flight of stairs, can not walk 500 m, suffering from more than 5 diseases, body mass decline a total of 5 indicators, using two classification scoring method, a total of 5 points.
0 was classified as no frailty, 1-2 as pre-frailty, and ≥3 as frailty.
Measured: 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.
Grip
Use electronic grip dynamometer (Model:
EH101) Before measurement, the instrument was calibrated to 0, the grip distance was adjusted, the fingers were naturally placed in the grip groove position, the study subjects were seated in the end position, the arm extension did not exceed 30 degrees, the upper arm and the forearm were 90 degrees, and the hands were measured with the maximum strength, the measurement interval was about 1 minute, so that the measuring hand could have enough relaxation and rest. A total of three tests were conducted.
Average the ultimate grip strength, accurate to 0.1kg.
Measured: 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 (2)
Patient Health Questionaire - 9 items，PHQ -9
It included 9 symptom scales and 1 overall functional assessment. Symptom scales were evaluated as follows: loss of interest, low mood, sleep disorders, fatigue, eating disorders, inferiority, difficulty in concentration, psychomotor delay, suicide symptoms, and item 10 was the overall functional assessment.
The item definition was expressed in the form of short sentences, with a 4-level score ranging from 0 to 3, and the frequency of symptom occurrence in nearly 2 weeks.
(0 indicates no symptoms, 1 indicates several days of symptoms, 2 indicates more than 7 days of symptoms, and 3 indicates almost every day of symptoms), the overall functional evaluation item is rated according to the degree of impact of symptoms on work, family or social function (0 indicates no, 1 indicates some impact, 2 indicates very impact, and 3 indicates very impact).
Measured: 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.
HendrichⅡfall risk model,HFRM
There were 8 items including male, depressive state, dizziness, taking anti-epileptic drugs, standing up and walking test, and confusion. The total score was 16 points, and ≥5 was classified as high risk
Measured: Acute ischemic stroke was evaluated within 48h of intravenous thrombolysis up to 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start1 Aug 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- xuemei zhang, master, Study chair, Affiliated Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06391502
- Sponsor's protocol ID
- zhangxuemei
- Status last verified
- Apr 2024
- First submitted
- 7 Jan 2024
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Exercise Intervention protocols
Publications
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.
PubMed 30419096Casas-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.
PubMed 35150086Perez-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.
PubMed 35180287Martinez-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.
PubMed 26374430Casas-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.
PubMed 31208471Carli 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.
PubMed 31968063Izquierdo M. [Multicomponent physical exercise program: Vivifrail]. Nutr Hosp. 2019 Jul 1;36(Spec No2):50-56. doi: 10.20960/nh.02680. Spanish.
PubMed 31189323Sanchez-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.
PubMed 36580558Courel-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.
PubMed 33296679Izquierdo 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.
PubMed 27499307Sanchez-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.
PubMed 35870875
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Multi-component Exercise Intervention Program on the Degree of Frailty in Hospitalized Patients After Venous Hemolysis in Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT06391502
- Acronym / sponsor ID
- zhangxuemei
- Conditions
- Ischemic Stroke, Exercise Therapy, Frailty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine exercise group | No intervention | –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. |
| Multicomponent exercise group | Experimental | Behavioral: Multi-component Exercise Intervention ProgramSelect 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/ |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Over 65 years of age;
- Hospitalized patients diagnosed with ischemic stroke;
- barthel index ≥60;
- Muscle strength of both upper and lower limbs is above grade 3;
- The pre-frailty and frailty state of the modified 5 Frailty Index (mFI-5) standard;
Key exclusion criteria (3 listed)
- fracture (within three months),
- severe cognitive impairment, or severe dementia;
- unable or unwilling to cooperate, any other unstable medical condition, or conditions that would prevent physical activity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-component Exercise Intervention ProgramThe 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. | Behavioural | Multicomponent exercise group |
Primary outcome
Short Physical Performance Battery（SPPB）
Time frame: 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.
The SPPB test to determine the level of frailty is a composite of the following three separate measures: 1. - Balance test. 2. - Walking speed test over 4 meters. 3. - Test of getting up from a chair. Add the points of the SPPB test (1 to 3) to determine the grade. * If due to limitations, you have not performed the SPPB test and you have elected to use the 6-meter walking test, the following values will be used to recommend the physical exercise program. Points 0-3 scores are considered as disability and given program A intervention; A score of 4-6 is considered as the early stage of asthenia and B intervention program is given; A score of 7-9 was considered as weak and C intervention program was given; A score of 10-12 is considered as healthy people and D intervention program is given
Modified Barthel Index
Time frame: 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.
The assessment of the individual's daily living ability includes 10 items, including eating, decoration, bathing, etc. Each index is divided into 5 levels: complete dependence, greater dependence, medium dependence, lesser dependence, and independence. The higher the score, the better the independence of daily life, a total of 100 points
FRAIL Scale
Time frame: 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.
Including fatigue, can not go up a flight of stairs, can not walk 500 m, suffering from more than 5 diseases, body mass decline a total of 5 indicators, using two classification scoring method, a total of 5 points. 0 was classified as no frailty, 1-2 as pre-frailty, and ≥3 as frailty.
Grip
Time frame: 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.
Use electronic grip dynamometer (Model: EH101) Before measurement, the instrument was calibrated to 0, the grip distance was adjusted, the fingers were naturally placed in the grip groove position, the study subjects were seated in the end position, the arm extension did not exceed 30 degrees, the upper arm and the forearm were 90 degrees, and the hands were measured with the maximum strength, the measurement interval was about 1 minute, so that the measuring hand could have enough relaxation and rest. A total of three tests were conducted. Average the ultimate grip strength, accurate to 0.1kg.
2 secondary outcomes
Patient Health Questionaire - 9 items，PHQ -9
Time frame: 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.
HendrichⅡfall risk model,HFRM
Time frame: Acute ischemic stroke was evaluated within 48h of intravenous thrombolysis up to 4 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Results publication: PubMed 30419096Martinez-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.
- Results publication: PubMed 35150086Casas-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.
- Results publication: PubMed 35180287Perez-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.
- Results publication: PubMed 26374430Martinez-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.
- Results publication: PubMed 31208471Casas-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.
- Results publication: PubMed 31968063Carli 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.
- Results publication: PubMed 31189323Izquierdo M. [Multicomponent physical exercise program: Vivifrail]. Nutr Hosp. 2019 Jul 1;36(Spec No2):50-56. doi: 10.20960/nh.02680. Spanish.
- Results publication: PubMed 36580558Sanchez-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.
- Results publication: PubMed 33296679Courel-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.
- Results publication: PubMed 27499307Izquierdo 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.
- Results publication: PubMed 35870875Sanchez-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.
- Individual participant dataSharing planned: No. Exercise Intervention protocols
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
xuemei zhang, master study chair
Affiliated Hospital of Nantong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-component Exercise Intervention Program in people with Ischemic Stroke and Exercise Therapy, run by Affiliated Hospital of Nantong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xuemei zhang, master (15896269868, 2557989983@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Physical Performance Battery（SPPB） (time frame: 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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06391502, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2024.