Melanoma Clinical Trial
Official title:
Feasibility and Safety Profile of a 3-month Aerobic and Resistance Exercise Intervention for Individuals Diagnosed With Melanoma
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. Eligible
participants (n=24) will be randomized into 3 months of wellness education (n=12) or
structured exercise (n=12).
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.
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