Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

3-month Aerobic and Resistance Exercise Intervention for Individuals Diagnosed With Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03825913
Recruitment Status : Not yet recruiting
First Posted : February 1, 2019
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Eduard Tiozzo, PhD, University of Miami

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).


Condition or disease Intervention/treatment Phase
Melanoma Behavioral: Exercise Intervention Behavioral: Wellness Intervention Not Applicable

Detailed Description:

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Feasibility and Safety Profile of a 3-month Aerobic and Resistance Exercise Intervention for Individuals Diagnosed With Melanoma
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : December 1, 2020


Arm Intervention/treatment
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.

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.


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: 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.




Primary Outcome Measures :
  1. Feasibility Assessment [ Time Frame: 12 weeks ]
    Less than 20% attrition rate for the intervention group

  2. Adherence Assessment [ Time Frame: 12 weeks ]
    80% or higher of the exercise sessions completed


Secondary Outcome Measures :
  1. FACT-M (Functional Assessment of Cancer Therapy - Melanoma) [ Time Frame: 6 and 12 weeks ]
    Quality of Life

  2. 6-minute Walk Test [ Time Frame: 12 weeks ]
    Cardiorespiratory Fitness

  3. Hand Grip [ Time Frame: 12 weeks ]
    Muscular Strength

  4. 30-sec Chair Stand [ Time Frame: 12 weeks ]
    Functional Status

  5. Food Frequency Questionnaire [ Time Frame: 12 weeks ]
    Nutritional Intake

  6. SEBI (Sun Exposure and Behavior Inventory) [ Time Frame: 12 weeks ]
    Sun Exposure

  7. FACIT (Functional Assessment of Chronic Illness Therapy [ Time Frame: 6 and 12 weeks ]
    Fatigue



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03825913


Locations
Layout table for location information
United States, Florida
University of Miami Not yet recruiting
Miami, Florida, United States, 33136
Contact: Eduard Tiozzo, PhD    305-243-6912    etiozzo@miami.edu   
Principal Investigator: Eduard Tiozzo, PhD         
Sponsors and Collaborators
University of Miami
Investigators
Layout table for investigator information
Principal Investigator: Eduard Tiozzo, PhD University of Miami

Layout table for additonal information
Responsible Party: Eduard Tiozzo, PhD, Instructor, University of Miami
ClinicalTrials.gov Identifier: NCT03825913     History of Changes
Other Study ID Numbers: 20180174
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eduard Tiozzo, PhD, University of Miami:
Melanoma

Additional relevant MeSH terms:
Layout table for MeSH terms
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas