Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06509282
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-05-24
Brief Title:
Personalized Concurrent Exercise for Cardiovascular Risk Control and Fitness in Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy of a Personalized Concurrent Exercise Prescription Guide for Controlling Cardiovascular Risk and Enhancing Physical Fitness in Adults From a Cardiovascular Health Program A Pilot Randomized Controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-07
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:
None
Brief Summary:
Aim To determine the efficacy of a personalized concurrent exercise prescription guide combined with pharmacological treatment compared to pharmacological treatment alone in controlling cardiovascular risk factors and physical capacity in adults enrolled in a Cardiovascular Health Program
Research Design This pilot randomized controlled clinical trial RCT evaluates the efficacy of a personalized concurrent exercise prescription guide combined with pharmacological treatment versus pharmacological treatment alone Outcomes blood pressure fasting glucose total cholesterol and triglycerides muscle strength cardiorespiratory capacity body composition adherence to the exercise guide and patient perception of intervention effects sociodemographic and medical background physical activity level Population Adult users of the Cardiovascular Health Program at the External CESFAM in Valdivia will be recruited during regular check-up hours Detailed study information will be provided and informed consent obtained
Sample Size The sample size is 15 subjects per group accounting for a 30 dropout rate resulting in 39 participants Participants will be randomly assigned to experimental EG or control groups CG with a 11 allocation ratio Allocation concealment will be ensured with opaque sealed envelopes
Evaluations Pre- and post-intervention evaluations will be conducted in both groups Sociodemographic and medical background information will be collected through clinical record reviews Blood pressure heart rate glucose triglycerides cholesterol adherence to the exercise guide and patient perception of intervention effects will be measured using standardized procedures by trained kinesiologists
Research Design This pilot randomized controlled clinical trial RCT evaluates the efficacy of a personalized concurrent exercise prescription guide combined with pharmacological treatment versus pharmacological treatment alone Outcomes blood pressure fasting glucose total cholesterol and triglycerides muscle strength cardiorespiratory capacity body composition adherence to the exercise guide and patient perception of intervention effects sociodemographic and medical background physical activity level Population Adult users of the Cardiovascular Health Program at the External CESFAM in Valdivia will be recruited during regular check-up hours Detailed study information will be provided and informed consent obtained
Sample Size The sample size is 15 subjects per group accounting for a 30 dropout rate resulting in 39 participants Participants will be randomly assigned to experimental EG or control groups CG with a 11 allocation ratio Allocation concealment will be ensured with opaque sealed envelopes
Evaluations Pre- and post-intervention evaluations will be conducted in both groups Sociodemographic and medical background information will be collected through clinical record reviews Blood pressure heart rate glucose triglycerides cholesterol adherence to the exercise guide and patient perception of intervention effects will be measured using standardized procedures by trained kinesiologists
Detailed Description:
SCIENTIFIC COMPONENT METHODOLOGY ETHICS AND PLANNING
RESEARCH QUESTION AND HYPOTHESIS Research Question What is the efficacy of a personalized concurrent exercise prescription guide combined with pharmacological treatment compared to pharmacological treatment alone in controlling cardiovascular risk factors and physical capacity in adult users of the Cardiovascular Health Program at the External CESFAM in Valdivia during 2024 Hypothesis H1 The efficacy of a personalized concurrent exercise prescription guide combined with pharmacological treatment is greater than pharmacological treatment alone in controlling cardiovascular risk factors CVRF and physical capacity in adult users of the Cardiovascular Health Program at the External CESFAM in Valdivia during 2024 group difference hypothesis H0 The efficacy of a personalized concurrent exercise prescription guide combined with pharmacological treatment is equal to pharmacological treatment alone in controlling CVRF and physical capacity in adult users of the Cardiovascular Health Program at the External CESFAM in Valdivia during 2024 group difference hypothesis Statistical Hypothesis
Group difference hypothesis
H0 μA μB
H1 μA μB OBJECTIVES General Objective To determine the efficacy of a personalized concurrent exercise prescription guide combined with pharmacological treatment compared to pharmacological treatment alone in controlling cardiovascular risk factors and physical capacity in adult users of the Cardiovascular Health Program at the External CESFAM in Valdivia during 2024
222 Specific Objectives
To describe the effects of applying a personalized concurrent exercise prescription guide on cardiovascular risk factors in adult users of the Cardiovascular Health Program at the External CESFAM in Valdivia
To describe the effects of applying a personalized concurrent exercise prescription guide on physical capacity in adult users of the Cardiovascular Health Program at the External CESFAM in Valdivia
To evaluate adherence to the personalized concurrent exercise guide and pharmacological treatment in adult users of the Cardiovascular Health Program at the External CESFAM in Valdivia
To describe the clinical significance of the interventions through the calculation of effect size and the clinical relevance perceived by the participants regarding the interventions
23 METHODOLOGY AND PROCEDURES Research Design The research design corresponds to a pilot randomized controlled clinical trial RCT with parallel groups and superiority This design aligns with the general objective and proposed hypothesis aiming to evaluate the efficacy of a personalized concurrent exercise prescription guide combined with pharmacological treatment compared to pharmacological treatment alone in controlling cardiovascular risk factors and physical capacity
The primary study variables include blood pressure fasting glucose total cholesterol and triglycerides which are standard measurements for the Cardiovascular Health Program Secondary variables include sociodemographic and medical background level of physical activity muscle strength cardiorespiratory capacity body composition adherence to the exercise guide and patient perception of changes experienced due to the intervention
Population The study population will consist of adult users of the Cardiovascular Health Program PSCV enrolled in the External CESFAM in Valdivia The research team will directly invite PSCV users during their regular check-up hours Research professionals will be properly identified as staff from Universidad San Sebastián and will provide detailed information about the research the exercise prescription guide application program duration benefits and risks Interested participants will be asked to sign informed consent The recruitment period will last up to 1 month extendable by another month if necessary to obtain the required sample size
Sample Size Calculation
The sample size calculation is based on recommendations from the literature for pilot studies and includes
T-test - Means difference between two independent means
Type I error 5
Statistical power 80
Effect size ES 05 according to Cohens classification Using these parameters the recommended total sample size is fifteen subjects per group Assuming a 30 dropout rate the total population will correspond to thirty-nine participants After the eligibility process participants will be randomly assigned to an experimental group EG and a control group CG using a 11 allocation ratio through an online randomization system Allocation concealment will be maintained using opaque sealed and consecutively numbered envelopes
The experimental group will receive the intervention based on the personalized exercise prescription guide plus their usual pharmacological treatment associated with the PSCV while the control group will maintain their usual pharmacological treatment associated with the PSCV
Information Production Techniques All evaluations will be performed pre- and post-intervention in both the experimental and control groups
Clinical Record Review
The PSCVs responsible physician with prior authorization from the External CESFAMs management and approval from the Valdivia Health Service Ethics Committee will review the participants medical records collecting information on sociodemographic and medical background sex age education time in the cardiovascular health program medical history medications dosage and duration of medication use These variables will be used to characterize the study sample
Evaluations and follow-up will be conducted by trained Kinesiologists in evaluation techniques exercise prescription and cardiovascular risk factors at the University of San Sebastián Health Center in Valdivia A professional Kinesiologist will measure the variables blinded to the participants intervention assignment These evaluations will encompass Cardiovascular Variables Evaluation Cardiovascular Risk Factor Metabolic Variables Health-related Physical Capacity Adherence to Treatment and the Global Rating of Change Scale
24 ANALYSIS OF ETHICAL IMPLICATIONS Risk-Benefit Analysis This study adheres to the Declaration of Helsinki ensuring informed consent is obtained from all participants The intervention will be conducted in both groups with evaluations presenting minimal risk Users may experience post-exercise muscle fatigue which could last up to 48 hours mitigated through education about exercise effects The benefits include updated knowledge about participants health status and physical capacity with personalized exercise shown to effectively control cardiovascular risk factors
Confidentiality Protection The clinical record review will be conducted at the External CESFAM by the PSCV responsible and physical evaluations will be conducted at the University of San Sebastián Health Center Participants will be assigned unique codes to preserve anonymity with informed consent clearly stating data will not be used for purposes other than the study Collected information will be stored securely by the Principal Investigator for 4 years after which it will be handed over to the CESFAM Only the research team will have access to the results
RESEARCH QUESTION AND HYPOTHESIS Research Question What is the efficacy of a personalized concurrent exercise prescription guide combined with pharmacological treatment compared to pharmacological treatment alone in controlling cardiovascular risk factors and physical capacity in adult users of the Cardiovascular Health Program at the External CESFAM in Valdivia during 2024 Hypothesis H1 The efficacy of a personalized concurrent exercise prescription guide combined with pharmacological treatment is greater than pharmacological treatment alone in controlling cardiovascular risk factors CVRF and physical capacity in adult users of the Cardiovascular Health Program at the External CESFAM in Valdivia during 2024 group difference hypothesis H0 The efficacy of a personalized concurrent exercise prescription guide combined with pharmacological treatment is equal to pharmacological treatment alone in controlling CVRF and physical capacity in adult users of the Cardiovascular Health Program at the External CESFAM in Valdivia during 2024 group difference hypothesis Statistical Hypothesis
Group difference hypothesis
H0 μA μB
H1 μA μB OBJECTIVES General Objective To determine the efficacy of a personalized concurrent exercise prescription guide combined with pharmacological treatment compared to pharmacological treatment alone in controlling cardiovascular risk factors and physical capacity in adult users of the Cardiovascular Health Program at the External CESFAM in Valdivia during 2024
222 Specific Objectives
To describe the effects of applying a personalized concurrent exercise prescription guide on cardiovascular risk factors in adult users of the Cardiovascular Health Program at the External CESFAM in Valdivia
To describe the effects of applying a personalized concurrent exercise prescription guide on physical capacity in adult users of the Cardiovascular Health Program at the External CESFAM in Valdivia
To evaluate adherence to the personalized concurrent exercise guide and pharmacological treatment in adult users of the Cardiovascular Health Program at the External CESFAM in Valdivia
To describe the clinical significance of the interventions through the calculation of effect size and the clinical relevance perceived by the participants regarding the interventions
23 METHODOLOGY AND PROCEDURES Research Design The research design corresponds to a pilot randomized controlled clinical trial RCT with parallel groups and superiority This design aligns with the general objective and proposed hypothesis aiming to evaluate the efficacy of a personalized concurrent exercise prescription guide combined with pharmacological treatment compared to pharmacological treatment alone in controlling cardiovascular risk factors and physical capacity
The primary study variables include blood pressure fasting glucose total cholesterol and triglycerides which are standard measurements for the Cardiovascular Health Program Secondary variables include sociodemographic and medical background level of physical activity muscle strength cardiorespiratory capacity body composition adherence to the exercise guide and patient perception of changes experienced due to the intervention
Population The study population will consist of adult users of the Cardiovascular Health Program PSCV enrolled in the External CESFAM in Valdivia The research team will directly invite PSCV users during their regular check-up hours Research professionals will be properly identified as staff from Universidad San Sebastián and will provide detailed information about the research the exercise prescription guide application program duration benefits and risks Interested participants will be asked to sign informed consent The recruitment period will last up to 1 month extendable by another month if necessary to obtain the required sample size
Sample Size Calculation
The sample size calculation is based on recommendations from the literature for pilot studies and includes
T-test - Means difference between two independent means
Type I error 5
Statistical power 80
Effect size ES 05 according to Cohens classification Using these parameters the recommended total sample size is fifteen subjects per group Assuming a 30 dropout rate the total population will correspond to thirty-nine participants After the eligibility process participants will be randomly assigned to an experimental group EG and a control group CG using a 11 allocation ratio through an online randomization system Allocation concealment will be maintained using opaque sealed and consecutively numbered envelopes
The experimental group will receive the intervention based on the personalized exercise prescription guide plus their usual pharmacological treatment associated with the PSCV while the control group will maintain their usual pharmacological treatment associated with the PSCV
Information Production Techniques All evaluations will be performed pre- and post-intervention in both the experimental and control groups
Clinical Record Review
The PSCVs responsible physician with prior authorization from the External CESFAMs management and approval from the Valdivia Health Service Ethics Committee will review the participants medical records collecting information on sociodemographic and medical background sex age education time in the cardiovascular health program medical history medications dosage and duration of medication use These variables will be used to characterize the study sample
Evaluations and follow-up will be conducted by trained Kinesiologists in evaluation techniques exercise prescription and cardiovascular risk factors at the University of San Sebastián Health Center in Valdivia A professional Kinesiologist will measure the variables blinded to the participants intervention assignment These evaluations will encompass Cardiovascular Variables Evaluation Cardiovascular Risk Factor Metabolic Variables Health-related Physical Capacity Adherence to Treatment and the Global Rating of Change Scale
24 ANALYSIS OF ETHICAL IMPLICATIONS Risk-Benefit Analysis This study adheres to the Declaration of Helsinki ensuring informed consent is obtained from all participants The intervention will be conducted in both groups with evaluations presenting minimal risk Users may experience post-exercise muscle fatigue which could last up to 48 hours mitigated through education about exercise effects The benefits include updated knowledge about participants health status and physical capacity with personalized exercise shown to effectively control cardiovascular risk factors
Confidentiality Protection The clinical record review will be conducted at the External CESFAM by the PSCV responsible and physical evaluations will be conducted at the University of San Sebastián Health Center Participants will be assigned unique codes to preserve anonymity with informed consent clearly stating data will not be used for purposes other than the study Collected information will be stored securely by the Principal Investigator for 4 years after which it will be handed over to the CESFAM Only the research team will have access to the results
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