Effects of Combined Training in Prostate Cancer Patients (Proactive)
Effect of Combined Training on Quality of Life, Functional Capacity, Cardiovascular Function, and Body Composition in Prostate Cancer Patients Undergoing Androgen Suppression Therapy: a Randomized Controlled Clinical Trial
Prostate cancer is the most prevalent type among men in Brazil, after non-melanoma skin cancer. One of the main treatment approaches is androgen suppression therapy (AST), which, although effective in controlling tumor growth, leads to several adverse effects such as erectile dysfunction, fatigue, reduced muscle mass, increased body fat percentage, decreased functional capacity and muscle strength, as well as a higher risk of cardiovascular events due to the sharp decline in testosterone and dihydrotestosterone. These factors significantly impair patients' quality of life. Physical exercise has been shown to mitigate such effects; however, in Brazil, only one study has so far evaluated the impact of exercise in men undergoing AST.
Given this context, the aim of the present study is to assess the effect of supervised physical exercise on quality of life, functional capacity, cardiovascular parameters, handgrip strength, and physical activity levels in men with prostate cancer undergoing AST. A randomized controlled clinical trial will be conducted, with patients allocated into an intervention group (IG) and a control group (CG). Data collection and the exercise intervention will take place at the Rehabilitation Center of the Sports Center at the Federal University of Santa Catarina (UFSC). The IG will participate in a supervised multicomponent exercise program including muscle strength, aerobic capacity, motor coordination, and flexibility, over 12 weeks, with 60-minute sessions three times per week.
Outcomes will be assessed before and after the intervention, covering quality of life (SF-36, EORTC QLQ-BR30, and EORTC QLQ-PR25 questionnaires), functional capacity (submaximal treadmill test, six-minute walk test, timed-up and go, 30-second sit-to-stand, and modified sit-and-reach), cardiovascular parameters (office and ambulatory systolic and diastolic blood pressure, resting heart rate, heart rate variability, flow-mediated dilation, arterial stiffness, and carotid intima-media thickness), body composition, and physical activity level. Adverse events will be recorded weekly. For statistical analysis, sample characterization variables will be examined using Student's t-test, Chi-square, and Fisher's exact test, while intervention outcomes will be analyzed using the generalized estimating equations (GEE) model, with significance set at p<0.05, both by intention-to-treat and per-protocol approaches.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
Prostate cancer is the most prevalent type among men in Brazil, after non-melanoma skin cancer. One of the main treatment approaches is androgen suppression therapy (AST), which, although effective in controlling tumor growth, leads to several adverse effects such as erectile dysfunction, fatigue, reduced muscle mass, increased body fat percentage, decreased functional capacity and muscle strength, as well as a higher risk of cardiovascular events due to the sharp decline in testosterone and dihydrotestosterone. These factors significantly impair patients' quality of life. Physical exercise has been shown to mitigate such effects; however, in Brazil, only one study has so far evaluated the impact of exercise in men undergoing AST.
Given this context, the aim of the present study is to assess the effect of supervised physical exercise on quality of life, functional capacity and cardiovascular parameters in men with prostate cancer undergoing AST. A randomized controlled clinical trial will be conducted, with patients allocated into an intervention group (IG) and a control group (CG). Data collection and the exercise intervention will take place at the Rehabilitation Center of the Sports Center at the Federal University of Santa Catarina (UFSC). The IG will participate in a supervised combined exercise program including muscle strength and aerobic capacity, over 12 weeks, with 60-minute sessions, three times per week.
Outcomes will be assessed before and after the intervention, covering quality of life (SF-36, EORTC QLQ-BR30, and EORTC QLQ-PR25 questionnaires), functional capacity (maximal treadmill test, six-minute walk test, timed-up and go, 30-second sit-to-stand and handgrip strength), cardiovascular parameters (clinical and ambulatory systolic and diastolic blood pressure, resting heart rate, heart rate variability, flow-mediated dilation, arterial stiffness, and carotid intima-media thickness), body composition, and physical activity level. Adverse events will be recorded weekly. For statistical analysis, sample characterization variables will be examined using Student's t-test, Chi-square, and Fisher's exact test, while intervention outcomes will be analyzed using the generalized estimating equations (GEE) model, with significance set at p<0.05, both by intention-to-treat and per-protocol approaches.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
Clinical diagnosis of prostate cancer stages I-III; Currently undergoing androgen deprivation therapy (ADT); Aged 40 to 75 years; No participation in research involving physical exercise or any systematic physical exercise intervention during the four months preceding the intervention; Residence in the Greater Florianópolis region, Santa Catarina, Brazil; Provision of written informed consent.
Exclusion Criteria:
Current participation in a structured physical exercise program; Presence of musculoskeletal disorders or other diseases that may prevent participation in the intervention or the assessment procedures.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Combined training group
A supervised, in-person physical exercise program will be implemented, lasting 12 weeks, with a frequency of three weekly sessions, held on non-consecutive days, lasting approximately 60 minutes per session.
The first two weeks will be dedicated to familiarizing participants with the training protocol followed by 12 weeks of intervention.
The program will be structured in progressive mesocycles, with three weeks for aerobic training and strength training.
Each session will consist of three phases: (i) warm-up, with joint mobility exercises; (ii) main part, involving aerobic training and strength exercises; and (iii) cool-down, with stretching and relaxation exercises.
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The intervention will consist of a combined training protocol comprising aerobic and strength training. The aerobic training will be performed on a treadmill and the strength training on weight machines. |
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Žádný zásah: control session
Participants will be instructed to continue with their usual activities.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Health-related quality of life assessed by the 36-item short form health survey (SF-36)
Časové okno: From enrollment to the end of 12 weeks of physical exercise intervention.
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The 36-item short form health survey (SF-36) consists of 36 items distributed across eight domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Domain scores are transformed to a 0-100 scale, where 0 represents the worst health status and 100 represents the best health status. Higher scores indicate better health-related quality of life. Unit of measure: Score (0-100) |
From enrollment to the end of 12 weeks of physical exercise intervention.
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Health-related quality of life assessed by the european organisation for research and treatment of cancer quality of life questionnaire breast cancer module (EORTC QLQ-BR30)
Časové okno: From enrollment to the end of 12 weeks of physical exercise intervention.
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The european organisation for research and treatment of cancer quality of life questionnaire breast cancer module (EORTC QLQ-BR30) consists of 30 items assessing functional domains and symptoms related to breast cancer. Scores are linearly transformed to a 0-100 scale. For functional scales and global health status/quality of life scales, higher scores indicate better functioning or quality of life. For symptom scales, higher scores indicate greater symptom burden. Unit of measure: Score (0-100) |
From enrollment to the end of 12 weeks of physical exercise intervention.
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Health-related quality of life assessed by the european organisation for research and treatment of cancer quality of life questionnaire prostate cancer module (EORTC QLQ-PR25)
Časové okno: From enrollment to the end of 12 weeks of physical exercise intervention.
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The european organisation for research and treatment of cancer quality of life questionnaire prostate cancer module (EORTC QLQ-PR25) consists of 25 items assessing urinary, bowel, hormonal treatment-related, and sexual symptoms and functioning in patients with prostate cancer. Scores are linearly transformed to a 0-100 scale. For functional scales, higher scores indicate better functioning. For symptom scales, higher scores indicate greater symptom burden. Unit of measure: Score (0-100) |
From enrollment to the end of 12 weeks of physical exercise intervention.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Maximal aerobic capacity
Časové okno: From enrollment to the end of 12 weeks of physical exercise intervention.
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Maximal aerobic capacity will be assessed using a maximal treadmill exercise test performed at a fixed speed with 1% incline increments until voluntary exhaustion.
Peak oxygen uptake (VO₂peak) will be recorded in ml·kg-¹·min-¹.
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From enrollment to the end of 12 weeks of physical exercise intervention.
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Lower limb functional strength
Časové okno: From enrollment to the end of the 12-week physical exercise intervention.
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Lower limb functional strength will be assessed using the 30-second sit-to-stand test.
The outcome will be the number of completed sit-to-stand repetitions within 30 seconds.
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From enrollment to the end of the 12-week physical exercise intervention.
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Functional mobility
Časové okno: From enrollment to the end of the 12-week physical exercise intervention.
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Functional mobility will be assessed using the timed up and go (TUG) test performed at habitual speed and maximum speed.
The outcome will be the time required to complete the test, measured in seconds.
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From enrollment to the end of the 12-week physical exercise intervention.
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Handgrip strength
Časové okno: From enrollment to the end of the 12-week physical exercise intervention.
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Handgrip strength will be assessed through maximal voluntary isometric contraction using a hand dynamometer.
The outcome will be recorded in kilograms-force (kgf).
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From enrollment to the end of the 12-week physical exercise intervention.
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Systolic blood pressure
Časové okno: Baseline and after 12 weeks of intervention.
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Systolic blood pressure (SBP) will be measured using an OMRON automatic monitor (HEM-7113, Brazil). Unit of measure: mmhg |
Baseline and after 12 weeks of intervention.
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Diastolic blood pressure
Časové okno: Baseline and after 12 weeks of intervention.
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Diastolic blood pressure (DBP) will be measured using an OMRON automatic monitor (HEM-7113, Brazil). Unit of measure: mmhg |
Baseline and after 12 weeks of intervention.
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Flow-mediated dilation
Časové okno: Baseline and after 12 weeks of intervention.
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Vascular function will be assessed by flow-mediated dilation using a LOGIQ S7 expert ultrasound device (GE Healthcare). Unit of measure: % |
Baseline and after 12 weeks of intervention.
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Carotid intima-media thickness
Časové okno: Baseline and after 12 weeks of intervention.
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Carotid intima-media thickness will be assessed by B-mode ultrasound using a versana active device (GE Healthcare). Unit of measure: mm |
Baseline and after 12 weeks of intervention.
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Heart rate variability
Časové okno: Baseline and after 12 weeks of intervention.
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Cardiac autonomic modulation will be assessed through heart rate variability analysis. Unit of measure: (especificar o índice principal: RMSSD em ms, SDNN em ms, HF em ms² etc.). |
Baseline and after 12 weeks of intervention.
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24-hour ambulatory blood pressure
Časové okno: Baseline and after 12 weeks of intervention.
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Ambulatory blood pressure will be assessed over 24 hours using the dyna-MAPA device (Cardios). Unit of measure: mmhg |
Baseline and after 12 weeks of intervention.
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Body composition
Časové okno: From enrollment to the end of the 12-week physical exercise intervention
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Body composition will be assessed using dual-energy X-ray absorptiometry (DXA).
Outcomes will include total body fat percentage (%), fat mass (kg), lean mass (kg), and bone mineral density (g/cm²).
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From enrollment to the end of the 12-week physical exercise intervention
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Usual physical activity level
Časové okno: From enrollment to the end of the 12-week physical exercise intervention.
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Usual physical activity level will be assessed using a triaxial accelerometer.
Outcomes will include daily step count (steps/day), sedentary time (minutes/day), and time spent in moderate-to-vigorous physical activity (minutes/day).
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From enrollment to the end of the 12-week physical exercise intervention.
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Nutritional monitoring
Časové okno: From enrollment to the end of the 12-week physical exercise intervention.
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Diet quality will be assessed using the questionnaire "How is your diet?".
The outcome will be the total questionnaire score (points).
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From enrollment to the end of the 12-week physical exercise intervention.
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Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- Proactive study
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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