Fade to Fitness Program for Health-Related Quality of Life

Overseen By Guillermo M Wippold, PhD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of South Carolina

Disqualifiers: Other intervention, Special diet, Moving

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a program designed to boost the health and well-being of Black men by focusing on exercise, healthy eating, stress relief, and managing depression. The Fade to Fitness Program uses group discussions and support to empower participants and foster connection, with weekly meetings in community settings like barbershops. Men who identify as African American or Black American and can speak English are invited to join, provided they are not already part of another health program or on a special diet for serious health issues. As an unphased trial, this study offers a unique opportunity to enhance personal health and well-being in a supportive community environment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on improving health behaviors like physical activity and healthy eating.

What prior data suggests that the Fade to Fitness Program is safe?

Research shows that fitness programs like Fade to Fitness are generally safe and aim to improve quality of life. Because the program avoids drugs and medical procedures, the risk of serious side effects is lower.

The program relies on established principles of psychology and social support, emphasizing healthy lifestyle choices and encouragement. These programs typically include physical activity, healthy eating, and stress management, which most people find easy to follow.

Although specific data on negative effects for this program is unavailable, similar programs have proven safe and effective in enhancing overall well-being. Participants often feel more motivated and supported, leading to positive outcomes without significant risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Fade to Fitness Program because it offers a fresh approach to improving health-related quality of life by focusing on physical fitness. Unlike typical treatments that often rely on medication or therapy to manage symptoms, this program emphasizes a holistic, lifestyle-oriented method. The key feature that sets it apart is its focus on integrating fitness as a central component of daily life, which could lead to overall improved well-being and potentially reduce the need for more invasive interventions. This proactive strategy might inspire participants to adopt healthier habits that have long-lasting benefits beyond the scope of traditional treatments.

What evidence suggests that the Fade to Fitness Program is effective for improving health-related quality of life?

Research has shown that fitness programs can greatly improve quality of life. Regular exercise, whether frequent or occasional, enhances both physical and mental health. Studies have also found that participants perform better in fitness tests, such as walking or running, after engaging in these programs. Being active boosts overall health and helps manage stress and depression. This trial will evaluate the Fade to Fitness Program, which aims to improve health-related quality of life by focusing on key habits like exercise, healthy eating, and stress management. ^{2 5 6 7 8}

Who Is on the Research Team?

Guillermo M Wippold

Principal Investigator

University of South Carolina

Are You a Good Fit for This Trial?

The Fade to Fitness Program is for African American or Black American men aged 18-90 who speak English. It's not for those already in a health program, on strict diets for serious conditions, or planning to move within 6 months of starting the program.

Inclusion Criteria

I am an African American or Black American male aged 18-90.

Able to speak and understand English

Exclusion Criteria

Currently participating in another health promotion intervention

I am following a special diet for a serious health issue.

Intending to move within 6 months of participating in the intervention

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 1 week

Intervention

The Fade to Fitness Program is conducted with weekly sessions focusing on Physical Activity, Healthy Eating, Stress Management, and Depression Management.

5 months

Weekly sessions

Follow-up

Participants are monitored for changes in health behaviors and quality of life after the intervention.

5 months

What Are the Treatments Tested in This Trial?

Interventions

• The Fade to Fitness Program

Trial Overview

This trial tests the Fade to Fitness Program, aiming to boost overall health and life quality through physical activity, healthy eating, stress and depression management. The program includes weekly sessions with group discussions in barbershops.

How Is the Trial Designed?

Group I: The Fade to Fitness Program Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of South Carolina

Lead Sponsor

Trials

233

Recruited

122,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

The Exercise Harms Reporting Method (ExHaRM) was developed to systematically monitor and report adverse outcomes related to exercise in cancer survivors, addressing a gap in understanding the potential harms of exercise alongside its benefits.

ExHaRM provides a structured protocol for assessing and reporting exercise-related adverse outcomes, which can help clinicians and patients make informed decisions about exercise interventions in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practical suggestions for harms reporting in exercise oncology: the Exercise Harms Reporting Method (ExHaRM). Spence, RR., Sandler, CX., Jones, TL., et al.[2023]

Regular physical activity significantly reduces cardiovascular risk and mortality, with even low levels of exercise providing substantial health benefits for individuals, including those at high risk for cardiovascular events.

While exercise is generally safe, it can temporarily increase the risk of cardiovascular events during acute physical activity; however, these events are rare and can be mitigated through proper screening programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise: friend or foe? Dangardt, FJ., McKenna, WJ., Lüscher, TF., et al.[2022]

In a randomized controlled trial involving 209 elderly participants (average age 80), a home-based exercise program was found to be generally safe, with 151 adverse events reported, affecting 47% of participants.

Despite the program's safety, 14% of the adverse events were serious, highlighting that high levels of pre-existing morbidity in this population can pose challenges to maintaining consistent exercise participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in mobility-limited and chronically ill elderly adults participating in an exercise intervention study supported by general practitioner practices. Hinrichs, T., Bücker, B., Wilm, S., et al.[2015]

A six-month active retirement program for older Portuguese adults aims to improve health-related quality of life (HRQoL), body composition, and physical fitness through structured exercise, with assessments conducted before and after the program.

If effective, this program could be recommended for broader implementation in health and social services to promote physical activity and prevent diseases related to inactivity among older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Active Retirement Programme, a Randomized Controlled Trial of a Sensorimotor Training Programme for Older Adults: A Study Protocol. Cabo, CA., Fernandes, O., Mendoza-Muñoz, M., et al.[2023]

In a review of over 5,500 participants from 11 physical activity interventions, no serious study-related adverse events were reported, indicating a high level of safety in these exercise programs.

While minor musculoskeletal injuries were noted, the studies emphasized a 'start low and go slow' approach, suggesting that moderate-intensity physical activity is safe and effective for sedentary, chronically ill, or older populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. Ory, M., Resnick, B., Jordan, PJ., et al.[2022]

A study involving 52 older adults from diverse ethnic backgrounds revealed that factors such as class location, transportation, and facility quality significantly influence adherence to the Enhance Fitness program.

Social support from peers, family, and instructors, along with individual traits and past experiences, also play crucial roles in encouraging older adults to continue participating in exercise programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"It is our exercise family": experiences of ethnic older adults in a group-based exercise program. Chiang, KC., Seman, L., Belza, B., et al.[2021]

In a study of 167 older adults, those who continued resistance training after a structured program (TR group) showed significant long-term improvements in physical functioning and mental health compared to those who did not continue training (DT group).

The TR group maintained higher health-related quality of life (HRQOL) scores one year after the intervention, while the DT group experienced declines in several HRQOL measures, highlighting the importance of ongoing exercise for elderly individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The long-term effects of progressive resistance training on health-related quality in older adults. Inaba, Y., Obuchi, S., Arai, T., et al.[2019]

A 12-week lifestyle wellness program for 319 overweight and obese adults led to significant improvements in physiological health and health-related quality of life (HRQOL), with the exception of HDL levels.

Participants with diabetes (n=46) also experienced notable benefits, including weight loss and improved cardiovascular markers, highlighting the program's effectiveness, especially with higher attendance rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wellness in community living adults: the Weigh to Life program. Harrison, RL., Mattson, LK., Durbin, DM., et al.[2015]

Incorporating physical exercise into the care plans of cancer patients can significantly enhance their quality of life (QOL), suggesting that exercise is a beneficial component of cancer treatment.

The development of individualized exercise plans for cancer patients requires careful screening, assessment, and collaboration among healthcare professionals, highlighting the need for further research to establish effective exercise protocols in oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical exercise as an oncology nursing intervention to enhance quality of life. Smith, SL.[2007]

A systematic review of 18 randomized controlled trials involving older adults (aged 65 and over) found that exercise programs significantly reduced depressive symptoms, with a standardized mean difference of -0.36.

The same exercise interventions also led to notable improvements in quality of life (SMD 0.86) and self-esteem (SMD 0.49), indicating that tailored exercise programs can be an effective strategy for enhancing mental health and well-being in the elderly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of exercise programs on depressive symptoms, quality of life, and self-esteem in older people: a systematic review of randomized controlled trials. Park, SH., Han, KS., Kang, CB.[2022]

A randomized controlled trial involving 160 elderly participants showed that targeted exercise programs, such as adapted tai chi and cognition-action programs, helped maintain the ability to perform daily activities better than usual care over 12 months.

While the control group experienced a decline in health-related quality of life and worsening Neuropsychiatric Inventory scores, the intervention groups either maintained or improved their scores, indicating that these exercise programs can effectively support the well-being of institutionalized elderly individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of exercise programs to prevent decline in health-related quality of life in highly deconditioned institutionalized elderly persons: a randomized controlled trial. Dechamps, A., Diolez, P., Thiaudière, E., et al.[2010]

In a study of 217 participants (98 with type 2 diabetes and 119 without), those with diabetes reported lower health-related quality of life (HRQOL) scores, particularly in physical health and general health, compared to those without diabetes.

Higher levels of aerobic fitness were found to significantly improve HRQOL in individuals with type 2 diabetes, more so than reductions in body fat, suggesting that increasing fitness could be a key motivator for patients to engage in physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fatness and fitness: how do they influence health-related quality of life in type 2 diabetes mellitus? Bennett, WL., Ouyang, P., Wu, AW., et al.[2022]

A 12-week program of Thai Yoga significantly improved physical function and quality of life in sedentary adults over 60, with notable enhancements in chair-stand, arm-curl, and walking tests compared to a control group.

In contrast, Tai Chi did not show significant improvements over the control group, indicating that Thai Yoga may be a more effective low-intensity exercise option for this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thai Yoga improves physical function and well-being in older adults: A randomised controlled trial. Noradechanunt, C., Worsley, A., Groeller, H.[2018]

A 12-week supervised exercise program significantly improved walking ability in patients with arterial claudication compared to a home-based exercise program, with greater increases in claudication pain time and maximum walking time observed in the supervised group.

Both exercise programs led to improvements in quality of life as measured by the SF-36, but there were no significant differences between the groups in these quality of life measures, suggesting that home-based programs can be an effective alternative for patients with lower walking needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Value of a supervised exercise program for the therapy of arterial claudication. Patterson, RB., Pinto, B., Marcus, B., et al.[2019]

Researchers in resistance training studies often lack clear guidance and motivation for thorough adverse event (AE) reporting, which can lead to inconsistent practices.

There is a need for exercise-specific guidelines for AE reporting, as current standards are perceived as not applicable to exercise trials, highlighting the importance of tailored strategies to improve reporting consistency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Researchers' perspectives on adverse event reporting in resistance training trials: a qualitative study. El-Kotob, R., Pagcanlungan, JR., Craven, BC., et al.[2022]

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