Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06591325
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-04
Brief Title:
Twelve Weeks of Resistance Training is Equally As Effective At Improving Cardiovascular Risk Factors in Older Women with and Without Depression a Non-randomized Cross-over Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Twelve Weeks of Resistance Training is Equally As Effective At Improving Cardiovascular Risk Factors in Older Women with and Without Depression a Non-randomized Cross-over Trial
Status:
COMPLETED
Status Verified Date:
2024-09
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:
Background the purporse was to evaluate and compare the effects of 12 weeks of resistance training RT on cardiovascular disease CVD risk factors in older women with and without depressive disorders Methods We included 79 older women 52 without depressive disorders and 27 with a diagnosis of depressive disorders The 79 participants passed through 12 weeks of control condition and were instructed to maintain their habitual routine After the control period the participants were reevaluated and attended 12 weeks of RT The Beck Anxiety Inventory BAI and Patient Health Questionnaire-9 PHQ-9 were used to measure anxiety and depressive symptoms respectively The serum levels of high-sensitivity C-reactive protein glucose total cholesterol TC high-density lipoprotein cholesterol HDL-c low-density cholesterol LDL-c and triglycerides TG were used as cardiovascular risk factors The Linear Mixed Model LMM was used to compare between groups
Detailed Description:
1 Introduction It is estimated that 38 of the worldwide population 57 of adults older than 60 years experienced a depressive disorder diagnosis in 2023 1 Further depression is about 50 more common among women than men Depressive disorders represent a huge burden for society especially considering their association with the development of cardiometabolic risk factors and cardiovascular diseases CVD 23 For instance several studies found that people with depressive disorders have a higher risk of developing diabetes metabolic syndrome CVDs higher CVD mortality and all-cause mortality 45 Therefore depressive disorders increase healthcare costs 6 health service utilization 7 and reduce productivity 8 Thus CVD is the main potentially avoidable contributor to early deaths in patients with depression 4
Among the multiple strategies physical activity is a modifiable behavior that may act as adjuvant therapy for depressive disorders and an essential protective factor for cardiometabolic risk factors and CVD mainly in older adults 9-11 In this regard resistance training RT has been widely recommended for this population due to its positive impact on overall health and mainly to counteract the age-related decline in skeletal muscle mass and muscular strength 9 Particularly effects of RT has positive effects on cardiometabolic parameters 1213 body fat 14 cardiorespiratory fitness 15 central nervous system 16 and CVD 14
Beyond the benefits for physical health some systematic reviews and meta-analyses also showed that RT can be effective in reducing depressive and anxiety symptoms in older adults 101718 Additionally it seems that different clinical conditions ie with vs without depressive disorders could present different responses to an RT program as the participants with depressive disorders presented a higher reduction in depressive symptoms compared with their counterparts 10 This finding indicates that RT may be an effective and feasible intervention for older adults with depressive disorders Therefore besides cardiovascular benefits RT could also be an essential way to protect physical health among people with depressive disorders However to our knowledge there is a lack of studies investigating the effect of RT on CVD risk factors among people with depressive disorders In addition depression may impact traditional CVD risk factors such as diet exercise as well as adherence to medical treatment aimed at primary and secondary prevention of cardiovascular disease 19 Furthermore a previous study has shown the association between antidepressant medication and prevalence and poorer control of CVD risk factors in a population-based older adults sample 20 Further whilst it is generally known that RT can improve CVD in the general population 21 it is unclear if RT is equally effective in those with depression
Given the aforementioned the investigators aimed to evaluate the effects of 12 weeks of RT on CVD risk factors and anxiety and depressive symptoms among older women with and without depressive disorders Second the investigators compared the effects of RT on CVD risk factors and anxiety and depressive symptoms among older women with and without depressive disorders The investigators hypothesized that older women with depressive disorders could have a greater magnitude of improvement in CVD risk factors anxiety and depressive symptoms than older women without depressive disorders due to their worse clinical condition
2 Methods 21 Experimental Design
This current investigation is a secondary analysis of the Active Aging Longitudinal Study designed to analyze the effects of supervised structured and progressive RT programs on neuromuscular morphological physiological metabolic behavioral and cognitive outcomes in older women It was selected data collected between November 2021 and July 2022 for the present investigation This trial was a non-randomized cross-over trial conducted over 33 weeks and divided into two phases
1 Phase 1 12 weeks of control condition One hundred five older women were interviewed and 79 were selected from which 27 reported previous medical diagnoses of depressive disorders while the other 52 participants were free of depressive disorders Therefore the 79 participants passed through 12 weeks of control condition and were instructed to maintain their habitual routine Control Group without Depressive Disorders n 52 Control Group with Depressive Disorders n 27
2 Phase 2 12 weeks of RT After the control period the participants were reevaluated and started 12 weeks of RT Five participants dropped out of the experiment during the follow-up period three participants without depressive disorders and two participants with depressive disorders The dropout rate was 57 in participants without depressive disorders and 74 in participants with depressive disorders Thus the final sample of this period consisted of 74 older women Training Group with Depressive Disorders n 25 Training Group without Depressive Disorders n 49 Figure 1 shows the flowchart and timeline of this study
Mental health-related questionnaires BAI and PHQ-9 biochemical analysis lipid profile glucose and C-reactive protein and muscular strength tests 1-RM were performed before the control period between the control and intervention periods ie post-control and pre-intervention and after the intervention weeks 1-3 and 16-18 31-33 Figure 1
22 Participants The volunteers were recruited through local TV radio newspaper announcements and social media WhatsApp Facebook and Instagram Participants completed detailed health history questionnaires and were subsequently admitted to the study if they met the following inclusion criteria a females aged ampampgt 60 years b physically independent c had no cardiac orthopedic or musculoskeletal dysfunction that could impede physical exercise d not having uncontrolled diabetes mellitus or hypertension e not be involved in the practice of regular physical activity performed more than once a week over the three months before the start of the study f present the medical clearance from a cardiologist resting 12-lead electrocardiogram test personal interview and treadmill stress test when deemed necessary to attend RT without restriction To identify participants with depressive disorders we made an anamnesis where it was asked if the participant had a previous diagnosis of depressive disorders issued by a medical doctor or psychologist and is undergoing treatment for depressive disorders Participants signed a written informed consent after receiving a detailed description of the investigation procedures This study was conducted according to the Declaration of Helsinki and approved by the Local Ethics Committee
23 Resistance training program The RT program was performed in the morning and in groups three days per week Mondays Wednesdays and Fridays in the University fitness facility over 12 weeks Participants were personally supervised by Physical Education professionals 1-2 supervisors per exercise session with substantial RT experience to ensure consistent and safe exercise performance Throughout the intervention period the RT program was carried out on machines and free weights Ipiranga Fitness Presidente Prudente SP Brazil
The training program was carried out in groups Participants performed four exercises for the trunk and upper limbs chest press seated row triceps pushdown preacher curl and four exercises for the lower limbs horizontal leg press leg extension lying leg curl seated calf raise in three sets of 10-15 repetitions based on previous guidelines 922 The participants were instructed to inhale during the eccentric phase and exhale during the concentric phase while maintaining a constant movement velocity at a ratio of approximately 12 s concentric and eccentric muscle actions respectively Rest intervals were 1-2 and 2-3 min between sets and exercises The training load was individually adjusted for each exercise weekly according to the number of repetitions performed during the last training session to ensure that the subjects kept performing at the ideal intensity for the repetition zone When participants completed the upper limit of repetitions in all sets for two consecutive sessions the weight was increased by 2-5 for the upper limb exercises and 5-10 for the exercises of the lower limbs 17
24 Primary Outcomes
241 Cardiovascular risk factors Blood sample venous was collected in a tube containing a dipotassium ethylenediaminetetraacetic acid 12 ml vacuum-sealed system Vacutainer England between 700 and 900 am by a trained laboratory technician after an overnight fast of at least 12 h Participants rested in a seated position for at least five minutes before withdrawing 5 ml of blood from a prominent superficial vein in the antecubital space All samples were centrifuged at 3000 rpm for 15 min and plasma or serum aliquots were stored at -80 C until assayed As determined in human plasma inter- and intra-assay coefficients of variation were ampamplt 10 Measurements of serum levels of high-sensitivity C-reactive protein glucose total cholesterol TC high-density lipoprotein cholesterol HDL-c and triglycerides TG were determined by standard methods in a specialized laboratory at University Hospital The low-density lipoprotein cholesterol LDL-c was calculated using the following equation 23 LDL-c TC - HDL-c TG5 The analyses were performed using a Dimension RxL Max biochemical auto-analyzer system Siemens Dade Behring Erlangen Germany according to established methods in the literature consistent with the manufacturers protocol
25 Secondary Outcomes
251 Depressive and anxiety symptoms Depressive and anxiety symptoms were assessed using two self-administered questionnaires the Patient Health Questionnaire PHQ-924 and the Beck Anxiety Inventory BAI 25 respectively The PHQ-9 consists of nine questions regarding the presence and frequency of depressive symptoms during the previous two weeks The nine symptoms consist of depressed mood anhedonia loss of interest or pleasure in doing things sleep problems tiredness or lack of energy change in appetite or weight feelings of guilt or worthlessness problems concentrating feeling of sluggishness or restlessness and suicidal thoughts The frequency of each symptom is assessed on a Likert scale from 0 to 3 corresponding to the answers never several days more than half the days and almost every day respectively The BAI comprises 21 items statements about different anxiety symptoms with a 4-point Likert scale with the final score ranging from 0 to 63 Each item has four possible answers with scores from 0 to 3 0 Not at all 1 Mild but it didnt bother me much 2 Moderate it wasnt pleasant at times 3 Severe it bothered me a lot
252 Muscular strength Maximal dynamic strength was evaluated using one-repetition maximum 1RM tests on the leg extension exercise Ipiranga Fitness Presidente Prudente SP Brazil respectively following standard procedures 26 Three 1RM testing sessions were performed over the morning separated by 48-hour intervals In each session participants completed a warm-up of 10-15 repetitions with approximately 50 of the estimated load to the first attempt followed by three maximal attempts For the first day of testing the first selected load was based on the researchers experience and perception of the difficulty effort with which participants performed the warm-up If the first attempt was completed the load was added for subsequent attempts 3-10 of the previous effort If an attempt was unsuccessful the load was removed in the same proportion The rest period was three to five minutes between attempts The load for the first attempt in the second and third sessions was the maximal obtained in the previous session During each effort participants were encouraged to perform two repetitions with the selected load The 1RM was recorded as the heaviest load lifted in one voluntary muscle action among the three sessions Two experienced researchers supervised all testing sessions to standardize technique reliability and ensure the safety of participants The standard error of measurement SEM and intraclass correlation coefficient ICC were satisfactory SEM 20 kg ICC 097
26 Characteristics of the sample and potential confounders Age was assessed and presented continuously Body mass was measured to the nearest 01 kg using a calibrated electronic scale Balmak Laboratory Equipment Labstore Curitiba PR Brazil Height was measured with a stadiometer attached to the scale to the nearest 01 cm All participants wore light workout clothing and no shoes during the measurements Body mass index BMI was calculated as body mass in kilograms divided by the square of height in meters 27 The Brazilian version of the MoCA was used to analyze the global cognitive function The MoCA is a screening tool composed of 12 individually punctuated tasks grouped into eight different cognitive domains The total score ranges from 0 to 30 higher values reflect better cognition MoCA psychometric proprieties indicate a high sensitivity 81 and specificity 77 for detecting mild cognitive impairment MCI states in Brazilian older individuals 28
27 Statistical analysis It was used values of mean and standard deviation as well as relative frequency to describe the characteristics of the sample Potential differences between the groups during the baseline were assessed using chi-square categorical variables Kruskal-Wallis and one-way ANOVA continuous variables The values of pre- and post-control and RT groups were described using mean and standard deviation It was used linear mixed models to estimate the effect of the RT intervention among the participants with and without depressive disorders by adding an interaction term between time ie pre and post and group control and RT including the participant as a random level The investigators also used linear mixed models LMM to compare the RT intervention effectiveness among participants with and without depressive disorders adding an interaction term between time and group The effect size ES was calculated as the post-training mean minus the pretraining mean divided by the pooled pretraining SD 34 An ES of 000-019 was considered trivial 020-049 small 050-079 moderate and 080 large 24 The statistical analyses were conducted using the software JAMOVI version 2411 JAMOVI project Sydney AU and significance was accepted at P ampamplt 005
Among the multiple strategies physical activity is a modifiable behavior that may act as adjuvant therapy for depressive disorders and an essential protective factor for cardiometabolic risk factors and CVD mainly in older adults 9-11 In this regard resistance training RT has been widely recommended for this population due to its positive impact on overall health and mainly to counteract the age-related decline in skeletal muscle mass and muscular strength 9 Particularly effects of RT has positive effects on cardiometabolic parameters 1213 body fat 14 cardiorespiratory fitness 15 central nervous system 16 and CVD 14
Beyond the benefits for physical health some systematic reviews and meta-analyses also showed that RT can be effective in reducing depressive and anxiety symptoms in older adults 101718 Additionally it seems that different clinical conditions ie with vs without depressive disorders could present different responses to an RT program as the participants with depressive disorders presented a higher reduction in depressive symptoms compared with their counterparts 10 This finding indicates that RT may be an effective and feasible intervention for older adults with depressive disorders Therefore besides cardiovascular benefits RT could also be an essential way to protect physical health among people with depressive disorders However to our knowledge there is a lack of studies investigating the effect of RT on CVD risk factors among people with depressive disorders In addition depression may impact traditional CVD risk factors such as diet exercise as well as adherence to medical treatment aimed at primary and secondary prevention of cardiovascular disease 19 Furthermore a previous study has shown the association between antidepressant medication and prevalence and poorer control of CVD risk factors in a population-based older adults sample 20 Further whilst it is generally known that RT can improve CVD in the general population 21 it is unclear if RT is equally effective in those with depression
Given the aforementioned the investigators aimed to evaluate the effects of 12 weeks of RT on CVD risk factors and anxiety and depressive symptoms among older women with and without depressive disorders Second the investigators compared the effects of RT on CVD risk factors and anxiety and depressive symptoms among older women with and without depressive disorders The investigators hypothesized that older women with depressive disorders could have a greater magnitude of improvement in CVD risk factors anxiety and depressive symptoms than older women without depressive disorders due to their worse clinical condition
2 Methods 21 Experimental Design
This current investigation is a secondary analysis of the Active Aging Longitudinal Study designed to analyze the effects of supervised structured and progressive RT programs on neuromuscular morphological physiological metabolic behavioral and cognitive outcomes in older women It was selected data collected between November 2021 and July 2022 for the present investigation This trial was a non-randomized cross-over trial conducted over 33 weeks and divided into two phases
1 Phase 1 12 weeks of control condition One hundred five older women were interviewed and 79 were selected from which 27 reported previous medical diagnoses of depressive disorders while the other 52 participants were free of depressive disorders Therefore the 79 participants passed through 12 weeks of control condition and were instructed to maintain their habitual routine Control Group without Depressive Disorders n 52 Control Group with Depressive Disorders n 27
2 Phase 2 12 weeks of RT After the control period the participants were reevaluated and started 12 weeks of RT Five participants dropped out of the experiment during the follow-up period three participants without depressive disorders and two participants with depressive disorders The dropout rate was 57 in participants without depressive disorders and 74 in participants with depressive disorders Thus the final sample of this period consisted of 74 older women Training Group with Depressive Disorders n 25 Training Group without Depressive Disorders n 49 Figure 1 shows the flowchart and timeline of this study
Mental health-related questionnaires BAI and PHQ-9 biochemical analysis lipid profile glucose and C-reactive protein and muscular strength tests 1-RM were performed before the control period between the control and intervention periods ie post-control and pre-intervention and after the intervention weeks 1-3 and 16-18 31-33 Figure 1
22 Participants The volunteers were recruited through local TV radio newspaper announcements and social media WhatsApp Facebook and Instagram Participants completed detailed health history questionnaires and were subsequently admitted to the study if they met the following inclusion criteria a females aged ampampgt 60 years b physically independent c had no cardiac orthopedic or musculoskeletal dysfunction that could impede physical exercise d not having uncontrolled diabetes mellitus or hypertension e not be involved in the practice of regular physical activity performed more than once a week over the three months before the start of the study f present the medical clearance from a cardiologist resting 12-lead electrocardiogram test personal interview and treadmill stress test when deemed necessary to attend RT without restriction To identify participants with depressive disorders we made an anamnesis where it was asked if the participant had a previous diagnosis of depressive disorders issued by a medical doctor or psychologist and is undergoing treatment for depressive disorders Participants signed a written informed consent after receiving a detailed description of the investigation procedures This study was conducted according to the Declaration of Helsinki and approved by the Local Ethics Committee
23 Resistance training program The RT program was performed in the morning and in groups three days per week Mondays Wednesdays and Fridays in the University fitness facility over 12 weeks Participants were personally supervised by Physical Education professionals 1-2 supervisors per exercise session with substantial RT experience to ensure consistent and safe exercise performance Throughout the intervention period the RT program was carried out on machines and free weights Ipiranga Fitness Presidente Prudente SP Brazil
The training program was carried out in groups Participants performed four exercises for the trunk and upper limbs chest press seated row triceps pushdown preacher curl and four exercises for the lower limbs horizontal leg press leg extension lying leg curl seated calf raise in three sets of 10-15 repetitions based on previous guidelines 922 The participants were instructed to inhale during the eccentric phase and exhale during the concentric phase while maintaining a constant movement velocity at a ratio of approximately 12 s concentric and eccentric muscle actions respectively Rest intervals were 1-2 and 2-3 min between sets and exercises The training load was individually adjusted for each exercise weekly according to the number of repetitions performed during the last training session to ensure that the subjects kept performing at the ideal intensity for the repetition zone When participants completed the upper limit of repetitions in all sets for two consecutive sessions the weight was increased by 2-5 for the upper limb exercises and 5-10 for the exercises of the lower limbs 17
24 Primary Outcomes
241 Cardiovascular risk factors Blood sample venous was collected in a tube containing a dipotassium ethylenediaminetetraacetic acid 12 ml vacuum-sealed system Vacutainer England between 700 and 900 am by a trained laboratory technician after an overnight fast of at least 12 h Participants rested in a seated position for at least five minutes before withdrawing 5 ml of blood from a prominent superficial vein in the antecubital space All samples were centrifuged at 3000 rpm for 15 min and plasma or serum aliquots were stored at -80 C until assayed As determined in human plasma inter- and intra-assay coefficients of variation were ampamplt 10 Measurements of serum levels of high-sensitivity C-reactive protein glucose total cholesterol TC high-density lipoprotein cholesterol HDL-c and triglycerides TG were determined by standard methods in a specialized laboratory at University Hospital The low-density lipoprotein cholesterol LDL-c was calculated using the following equation 23 LDL-c TC - HDL-c TG5 The analyses were performed using a Dimension RxL Max biochemical auto-analyzer system Siemens Dade Behring Erlangen Germany according to established methods in the literature consistent with the manufacturers protocol
25 Secondary Outcomes
251 Depressive and anxiety symptoms Depressive and anxiety symptoms were assessed using two self-administered questionnaires the Patient Health Questionnaire PHQ-924 and the Beck Anxiety Inventory BAI 25 respectively The PHQ-9 consists of nine questions regarding the presence and frequency of depressive symptoms during the previous two weeks The nine symptoms consist of depressed mood anhedonia loss of interest or pleasure in doing things sleep problems tiredness or lack of energy change in appetite or weight feelings of guilt or worthlessness problems concentrating feeling of sluggishness or restlessness and suicidal thoughts The frequency of each symptom is assessed on a Likert scale from 0 to 3 corresponding to the answers never several days more than half the days and almost every day respectively The BAI comprises 21 items statements about different anxiety symptoms with a 4-point Likert scale with the final score ranging from 0 to 63 Each item has four possible answers with scores from 0 to 3 0 Not at all 1 Mild but it didnt bother me much 2 Moderate it wasnt pleasant at times 3 Severe it bothered me a lot
252 Muscular strength Maximal dynamic strength was evaluated using one-repetition maximum 1RM tests on the leg extension exercise Ipiranga Fitness Presidente Prudente SP Brazil respectively following standard procedures 26 Three 1RM testing sessions were performed over the morning separated by 48-hour intervals In each session participants completed a warm-up of 10-15 repetitions with approximately 50 of the estimated load to the first attempt followed by three maximal attempts For the first day of testing the first selected load was based on the researchers experience and perception of the difficulty effort with which participants performed the warm-up If the first attempt was completed the load was added for subsequent attempts 3-10 of the previous effort If an attempt was unsuccessful the load was removed in the same proportion The rest period was three to five minutes between attempts The load for the first attempt in the second and third sessions was the maximal obtained in the previous session During each effort participants were encouraged to perform two repetitions with the selected load The 1RM was recorded as the heaviest load lifted in one voluntary muscle action among the three sessions Two experienced researchers supervised all testing sessions to standardize technique reliability and ensure the safety of participants The standard error of measurement SEM and intraclass correlation coefficient ICC were satisfactory SEM 20 kg ICC 097
26 Characteristics of the sample and potential confounders Age was assessed and presented continuously Body mass was measured to the nearest 01 kg using a calibrated electronic scale Balmak Laboratory Equipment Labstore Curitiba PR Brazil Height was measured with a stadiometer attached to the scale to the nearest 01 cm All participants wore light workout clothing and no shoes during the measurements Body mass index BMI was calculated as body mass in kilograms divided by the square of height in meters 27 The Brazilian version of the MoCA was used to analyze the global cognitive function The MoCA is a screening tool composed of 12 individually punctuated tasks grouped into eight different cognitive domains The total score ranges from 0 to 30 higher values reflect better cognition MoCA psychometric proprieties indicate a high sensitivity 81 and specificity 77 for detecting mild cognitive impairment MCI states in Brazilian older individuals 28
27 Statistical analysis It was used values of mean and standard deviation as well as relative frequency to describe the characteristics of the sample Potential differences between the groups during the baseline were assessed using chi-square categorical variables Kruskal-Wallis and one-way ANOVA continuous variables The values of pre- and post-control and RT groups were described using mean and standard deviation It was used linear mixed models to estimate the effect of the RT intervention among the participants with and without depressive disorders by adding an interaction term between time ie pre and post and group control and RT including the participant as a random level The investigators also used linear mixed models LMM to compare the RT intervention effectiveness among participants with and without depressive disorders adding an interaction term between time and group The effect size ES was calculated as the post-training mean minus the pretraining mean divided by the pooled pretraining SD 34 An ES of 000-019 was considered trivial 020-049 small 050-079 moderate and 080 large 24 The statistical analyses were conducted using the software JAMOVI version 2411 JAMOVI project Sydney AU and significance was accepted at P ampamplt 005
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