Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
Inclusion criteria:(a) men and women (≥ 18 years of age) with a diagnosis of melanoma cancer within one year from diagnosis, (b) not meeting the guidelines for physical activity (less than 150 minutes of moderate intensity activity or 75 minutes of vigorous intensity activity a week for 6 weeks prior the enrollment) (c) a commitment to two weekly supervised exercise sessions or bi-monthly educational sessions for three months at University of Miami Miller School of Medicine (d) and able to understand, read and write English.
Exclusion criteria:(a) participants for whom physical activity is contraindicated because of comorbid conditions, (b) participants with dementia, altered mental status or psychiatric condition and (c) participants who are unwilling or unable to provide informed consent.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|University of Miami|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Eduard Tiozzo, PhD|
|Principal Investigator Affiliation||University of Miami|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Our proposed study will focus on addressing the feasibility, safety and benefits of a 3-month exercise intervention among individuals diagnosed with melanoma. The study will be conducted at University of Miami Miller School of Medicine. The eligible participants will meet the following inclusion and exclusion criteria. Inclusion criteria: (a) men and women (≥ 18 years of age) with melanoma cancer within one year from diagnosis, (b) not meeting the guidelines for physical activity (less than 150 minutes of moderate intensity activity or 75 minutes of vigorous intensity activity a week for 6 weeks prior the enrollment) (c) a commitment to two weekly supervised exercise sessions or bi-monthly educational sessions for three months at University of Miami Miller School of Medicine and (d) able to understand, read and write English. Exclusion criteria: (a) participants for whom physical activity is contraindicated because of comorbid conditions, (b) participants with dementia, altered mental status or psychiatric condition and (c) participants who are unwilling or unable to provide informed consent. The participants (n=24) will be randomized into 3 months of: 1) wellness education (n=12) or 2) structured exercise (n=12). All participants will receive standard treatment as directed by their oncologists. Individuals in the wellness education group will attend bi-monthly sessions where they will receive general wellness information pertaining to physical activity, nutrition, sleep, weight management and mindfulness. Individuals in the structured exercise group will attend supervised exercise sessions twice per week and receive a tailored daily walking plan using physical activity trackers. A comprehensive assessment will be conducted at baseline and 3-months, which will include demographics, medical and treatment history, anthropometrics, quality of life, physical fitness, past and current sun exposure, fatigue, and nutritional status. We plan the following specific aims: Aim 1: To assess feasibility, adherence, and safety of a 3-month supervised exercise program in melanoma patients. Aim 2: To evaluate the impact of a 3-month supervised exercise program on quality of life in melanoma patients. Aim 3: To evaluate the effect of a 3-month supervised exercise program on cardiorespiratory fitness and muscular strength in melanoma patients.
Active Comparator: Exercise Intervention
Subjects in the exercise group will participate in a 3-month exercise program at the University of Miami UHealth Fitness and Wellness Center. Participants will complete two exercise sessions a week, each 45-60 minutes long and on a one-on-one basis. In addition to two site visits, the participants will receive a tailored daily home-based walking plan. The participants will use physical activity trackers (Fitbit®), with an ultimate goal of achieving 10,000 steps by the end of the intervention. Participants in the exercise intervention will complete 24 sessions.
Sham Comparator: Wellness Intervention
For 3 months, the wellness education group will not be offered any form of supervised exercise program or receive any specific instructions on physical activity as part of the study. The participants in this group will attend educational sessions about different wellness topics, such as nutrition, sleep, weight management, mindfulness, and the overall benefits of increased physical activity. The wellness visits will be held two times per month, and similar to the exercise sessions of the intervention arm, they will be 45-60 minutes long and on a one-on-one basis. Participants in the wellness education group will complete 6 sessions.
Behavioral: - Exercise Intervention
Training sessions will include a split routine based on the day of the week. Session 1 (e.g. Tuesday) - aerobic exercise (20-30 min) followed by resistance training (10 stacked-weight machines: leg press, leg extension, leg curl, chest press, latissimus pull, shoulder press, seated row, triceps press, biceps curl, and chest fly) for 1-2 sets of 8-12 repetitions. Session 2 (e.g. Thursday) - resistance bands and body weight exercises (4-6 exercises, 2 sets of 10-20 repetitions) followed by core exercises (2-3 sets of 10-20 repetitions) and aerobic training (20-30 min) at the end. The starting training intensities will be at 50-55% of each individual's estimated maximum heart rate for aerobic exercise and one-repetition maximum for resistance training (assessed at baseline only for chest press and leg press). We plan a 5% monthly increase in the intensity to reach 65-70%% of one's maximum efforts by the end of the intervention.
Behavioral: - Wellness Intervention
In our setting, ten lectures in nutrition, exercise and various complementary and integrative medicine topics (e.g. acupuncture and Chinese medicine, mindfulness, quality sleep, etc.) were implemented among non-cancer individuals and modified based on their feedback.
Contact a Trial Team
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