Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06634147
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-03
Brief Title:
Prevention of Functional and Cognitive Impairment Through a Multicomponent Exercise Program in Hospitalized Older Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prevention of Functional and Cognitive Impairment Through a Multicomponent Exercise Program in Hospitalized Older Adults Geriatrics and Internal Medicine a Randomized Clinical Trial Multicenter Study HUN CHU-T ULSBM and HNSM
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREDISC
Brief Summary:
The goal of this clinical trial is to determine whether a multicomponent exercise program improves functional capacity and cognitive status in hospitalized elderly patients aged 75 and older Additionally the study aims to assess the impact of this program on medication use quality of life and overall health outcomes Key questions include whether the program enhances functional and cognitive capacities and which subgroups benefit most such as frail patients or those with cognitive impairment
Participants will engage in a structured exercise program that includes strength training balance exercises and walking all designed to improve mobility and reduce fall risk They will attend supervised sessions several times a week allowing for individualized attention and adjustments based on their abilities and health status
Throughout the study changes in functional capacity will be monitored using standardized assessments that measure mobility strength and overall physical functioning Cognitive assessments will evaluate any changes in cognitive status during the intervention and follow-up periods post-discharge Participants will provide information on medication usage to analyze whether the exercise program can reduce the need for medications or help manage common polypharmacy issues
Surveys and interviews will assess participants quality of life including physical emotional and social well-being before and after the intervention Follow-up assessments will track progress and outcomes ensuring long-term benefits of the exercise program are documented
The study will include a diverse sample from multiple centers focusing on individuals aged over 75 who are hospitalized in Geriatrics and Internal Medicine services across participating centers HUN CHU-T ULSBM and HNSM Exclusion criteria will ensure safety excluding those with terminal illnesses or significant contraindications for exercise
This clinical trial aims to recruit 296 patients providing valuable insights into the benefits of physical activity for elderly patients during hospitalization and informing future care practices
Participants will engage in a structured exercise program that includes strength training balance exercises and walking all designed to improve mobility and reduce fall risk They will attend supervised sessions several times a week allowing for individualized attention and adjustments based on their abilities and health status
Throughout the study changes in functional capacity will be monitored using standardized assessments that measure mobility strength and overall physical functioning Cognitive assessments will evaluate any changes in cognitive status during the intervention and follow-up periods post-discharge Participants will provide information on medication usage to analyze whether the exercise program can reduce the need for medications or help manage common polypharmacy issues
Surveys and interviews will assess participants quality of life including physical emotional and social well-being before and after the intervention Follow-up assessments will track progress and outcomes ensuring long-term benefits of the exercise program are documented
The study will include a diverse sample from multiple centers focusing on individuals aged over 75 who are hospitalized in Geriatrics and Internal Medicine services across participating centers HUN CHU-T ULSBM and HNSM Exclusion criteria will ensure safety excluding those with terminal illnesses or significant contraindications for exercise
This clinical trial aims to recruit 296 patients providing valuable insights into the benefits of physical activity for elderly patients during hospitalization and informing future care practices
Detailed Description:
The goal of this clinical trial is to learn if a multicomponent exercise program improves functional capacity and cognitive status in hospitalized elderly patients aged 75 and older Additionally the study aims to assess the impact of this program on medication use quality of life and the overall health outcomes of these patients The main questions it aims to answer are
1 Does the multicomponent exercise program enhance functional capacity in hospitalized elderly patients
2 Which subgroups of patients benefit the most from the intervention eg frail patients those with cognitive impairment or malnutrition
3 Does participation in the exercise program lead to a reduction in the consumption of medications and instances of iatrogenic complications
4 How does the exercise program affect the quality of life and sleep quality of the participants
5 What are the long-term effects of the exercise intervention on muscle mass balance and walking speed
6 Are there measurable changes at the omics level genomic proteomic metabolomic due to the exercise intervention
Researchers will compare the multicomponent exercise program to standard care to see if the exercise program leads to significant improvements in functional and cognitive outcomes This comparison will help determine the effectiveness of the exercise intervention in enhancing the overall well-being of elderly patients during their hospital stay
Participants will
Engage in a structured multicomponent exercise program designed specifically for elderly patients This program will include activities focused on strength training balance exercises and walking to improve mobility and reduce the risk of falls The exercises will be tailored to the individual capabilities of each participant ensuring safety and effectiveness
Attend supervised exercise sessions several times a week allowing for individualized attention and adjustments based on each participantamp39s abilities and health status These sessions will be conducted by trained physical therapists who specialize in geriatric care
Be monitored for changes in functional capacity using standardized assessments which will measure improvements in mobility strength and overall physical functioning Assessments will include tools such as the Timed Up and Go Test TUG the Berg Balance Scale and the 6-Minute Walk Test
Undergo cognitive assessments to evaluate any changes in cognitive status throughout the intervention and during follow-up periods after discharge Cognitive evaluations will include tests like the Mini-Mental State Examination MMSE and the Montreal Cognitive Assessment MoCA
Provide information on their medication usage to analyze whether the exercise program can reduce the need for medications or help manage polypharmacy issues commonly faced by elderly patients This will include a detailed review of current medications and any changes made during the study
Participate in surveys and interviews to assess their quality of life including physical emotional and social well-being before and after the intervention Quality of life will be measured using validated tools such as the Short Form Health Survey SF-36 and the EuroQol-5D EQ-5D
Attend follow-up assessments at designated intervals to track their progress and outcomes ensuring that any long-term benefits of the exercise program are recognized and documented Follow-ups will occur at 1 month 3 months and 6 months post-discharge
The study will include a diverse sample of participants from multiple centers ensuring a robust analysis of the interventionamp39s effects across different populations Inclusion criteria will focus on individuals aged over 75 years who are hospitalized in Geriatrics and Internal Medicine services across participating centers HUN CHU-T ULSBM and HNSM Participants must be capable of communication and ambulation either independently or with assistance
Exclusion criteria will ensure the safety and appropriateness of the intervention Individuals who explicitly refuse to participate or cannot provide informed consent will be excluded Additionally those with a life expectancy of less than three months terminal illnesses or significant medical contraindications for exercise will not be eligible Participants with moderate to severe neurocognitive disorders or disabilities that severely limit mobility will also be excluded to maintain the integrity of the intervention
Sample Size and Recruitment This clinical trial aims to recruit a total of 296 patients across the four participating centers Recruitment will be conducted through hospital admissions with potential participants identified by medical staff and referred to the research team Informed consent will be obtained from all participants or their legal representatives prior to enrollment
Data Collection and Analysis Data will be collected at baseline during the intervention and at follow-up assessments This will include demographic information clinical history baseline functional and cognitive assessments and post-intervention evaluations Statistical analyses will be performed to compare outcomes between the intervention and control groups using appropriate methods to account for potential confounding factors
Ethical Considerations This study will adhere to ethical guidelines for research involving human subjects The protocol will be reviewed and approved by the Institutional Review Board IRB at each participating center Informed consent will be obtained from all participants ensuring they understand the studyamp39s purpose procedures risks and benefits
Expected Outcomes The findings of this study may provide valuable insights into the benefits of physical activity for elderly patients during hospitalization By examining the outcomes related to functional capacity cognitive status medication use and quality of life the study seeks to inform future guidelines and practices for improving the care and rehabilitation of older adults in hospital settings Additionally the research may contribute to the understanding of how exercise interventions can positively impact health at the molecular level potentially leading to new therapeutic approaches for managing health in elderly populations
Ultimately the results of this clinical trial could have significant implications for enhancing the quality of care for hospitalized elderly patients reducing the burden of functional decline and improving overall health outcomes in this vulnerable population By demonstrating the effectiveness of a multicomponent exercise program the study could advocate for the integration of such programs into standard hospital care for older adults promoting healthier aging and better recovery from acute medical conditions
1 Does the multicomponent exercise program enhance functional capacity in hospitalized elderly patients
2 Which subgroups of patients benefit the most from the intervention eg frail patients those with cognitive impairment or malnutrition
3 Does participation in the exercise program lead to a reduction in the consumption of medications and instances of iatrogenic complications
4 How does the exercise program affect the quality of life and sleep quality of the participants
5 What are the long-term effects of the exercise intervention on muscle mass balance and walking speed
6 Are there measurable changes at the omics level genomic proteomic metabolomic due to the exercise intervention
Researchers will compare the multicomponent exercise program to standard care to see if the exercise program leads to significant improvements in functional and cognitive outcomes This comparison will help determine the effectiveness of the exercise intervention in enhancing the overall well-being of elderly patients during their hospital stay
Participants will
Engage in a structured multicomponent exercise program designed specifically for elderly patients This program will include activities focused on strength training balance exercises and walking to improve mobility and reduce the risk of falls The exercises will be tailored to the individual capabilities of each participant ensuring safety and effectiveness
Attend supervised exercise sessions several times a week allowing for individualized attention and adjustments based on each participantamp39s abilities and health status These sessions will be conducted by trained physical therapists who specialize in geriatric care
Be monitored for changes in functional capacity using standardized assessments which will measure improvements in mobility strength and overall physical functioning Assessments will include tools such as the Timed Up and Go Test TUG the Berg Balance Scale and the 6-Minute Walk Test
Undergo cognitive assessments to evaluate any changes in cognitive status throughout the intervention and during follow-up periods after discharge Cognitive evaluations will include tests like the Mini-Mental State Examination MMSE and the Montreal Cognitive Assessment MoCA
Provide information on their medication usage to analyze whether the exercise program can reduce the need for medications or help manage polypharmacy issues commonly faced by elderly patients This will include a detailed review of current medications and any changes made during the study
Participate in surveys and interviews to assess their quality of life including physical emotional and social well-being before and after the intervention Quality of life will be measured using validated tools such as the Short Form Health Survey SF-36 and the EuroQol-5D EQ-5D
Attend follow-up assessments at designated intervals to track their progress and outcomes ensuring that any long-term benefits of the exercise program are recognized and documented Follow-ups will occur at 1 month 3 months and 6 months post-discharge
The study will include a diverse sample of participants from multiple centers ensuring a robust analysis of the interventionamp39s effects across different populations Inclusion criteria will focus on individuals aged over 75 years who are hospitalized in Geriatrics and Internal Medicine services across participating centers HUN CHU-T ULSBM and HNSM Participants must be capable of communication and ambulation either independently or with assistance
Exclusion criteria will ensure the safety and appropriateness of the intervention Individuals who explicitly refuse to participate or cannot provide informed consent will be excluded Additionally those with a life expectancy of less than three months terminal illnesses or significant medical contraindications for exercise will not be eligible Participants with moderate to severe neurocognitive disorders or disabilities that severely limit mobility will also be excluded to maintain the integrity of the intervention
Sample Size and Recruitment This clinical trial aims to recruit a total of 296 patients across the four participating centers Recruitment will be conducted through hospital admissions with potential participants identified by medical staff and referred to the research team Informed consent will be obtained from all participants or their legal representatives prior to enrollment
Data Collection and Analysis Data will be collected at baseline during the intervention and at follow-up assessments This will include demographic information clinical history baseline functional and cognitive assessments and post-intervention evaluations Statistical analyses will be performed to compare outcomes between the intervention and control groups using appropriate methods to account for potential confounding factors
Ethical Considerations This study will adhere to ethical guidelines for research involving human subjects The protocol will be reviewed and approved by the Institutional Review Board IRB at each participating center Informed consent will be obtained from all participants ensuring they understand the studyamp39s purpose procedures risks and benefits
Expected Outcomes The findings of this study may provide valuable insights into the benefits of physical activity for elderly patients during hospitalization By examining the outcomes related to functional capacity cognitive status medication use and quality of life the study seeks to inform future guidelines and practices for improving the care and rehabilitation of older adults in hospital settings Additionally the research may contribute to the understanding of how exercise interventions can positively impact health at the molecular level potentially leading to new therapeutic approaches for managing health in elderly populations
Ultimately the results of this clinical trial could have significant implications for enhancing the quality of care for hospitalized elderly patients reducing the burden of functional decline and improving overall health outcomes in this vulnerable population By demonstrating the effectiveness of a multicomponent exercise program the study could advocate for the integration of such programs into standard hospital care for older adults promoting healthier aging and better recovery from acute medical conditions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None