Study Stopped
two key faculty members are no longer part of the study and institution
3-month Aerobic and Resistance Exercise Intervention for Individuals Diagnosed With Melanoma
Feasibility and Safety Profile of a 3-month Aerobic and Resistance Exercise Intervention for Individuals Diagnosed With Melanoma
1 other identifier
interventional
1
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2019
CompletedFirst Posted
Study publicly available on registry
February 1, 2019
CompletedStudy Start
First participant enrolled
November 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 21, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 21, 2020
CompletedAugust 28, 2020
August 1, 2020
4 months
January 30, 2019
August 26, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Feasibility Assessment
Less than 20% attrition rate for the intervention group
12 weeks
Adherence Assessment
80% or higher of the exercise sessions completed
12 weeks
Secondary Outcomes (7)
FACT-M (Functional Assessment of Cancer Therapy - Melanoma)
6 and 12 weeks
6-minute Walk Test
12 weeks
Hand Grip
12 weeks
30-sec Chair Stand
12 weeks
Food Frequency Questionnaire
12 weeks
- +2 more secondary outcomes
Study Arms (2)
Exercise Intervention
ACTIVE COMPARATORSubjects 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.
Wellness Intervention
SHAM COMPARATORFor 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.
Interventions
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.
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.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Miami
Miami, Florida, 33136, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eduard Tiozzo, PhD
University of Miami
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Instructor
Study Record Dates
First Submitted
January 30, 2019
First Posted
February 1, 2019
Study Start
November 6, 2019
Primary Completion
February 21, 2020
Study Completion
February 21, 2020
Last Updated
August 28, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share