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

Trial Summary

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 data supports the effectiveness of the Fade to Fitness Program treatment?

Research shows that exercise programs can improve quality of life in various groups, such as people with cancer, older adults, and those with type 2 diabetes. These findings suggest that the Fade to Fitness Program, which likely includes exercise, could also help improve health-related quality of life. ^{1 2 3 4 5}

Is the Fade to Fitness Program safe for participants?

Exercise programs, like the Fade to Fitness Program, are generally safe for most people, including those with chronic illnesses or limited mobility. While minor injuries, such as muscle strains, can occur, serious problems are rare and often preventable with proper screening and gradual increase in activity levels. ^{6 7 8 9 10}

How does the Fade to Fitness Program treatment differ from other treatments for improving health-related quality of life?

The Fade to Fitness Program is unique because it focuses on a group-based exercise approach, which can enhance social support and motivation among participants, especially ethnic older adults. This social aspect may help improve adherence to the program compared to other individual-based exercise treatments. ^{11 12 13 14 15}

What is the purpose of this trial?

The Fade to Fitness Program is a targeted intervention designed to improve the holistic health and quality of life among Black men. This comprehensive initiative focuses on four key health behaviors: Physical Activity, Healthy Eating, Stress Management, and Depression Management. It is grounded in psychological and social theories like Self-Determination Theory, Motivational Interviewing, and Social Cognitive Theory. The program emphasizes the importance of making informed choices, feeling competent and connected, and learning through observation and modeling. Facilitators play a pivotal role, leading group discussions, providing support, and fostering an inclusive atmosphere. The program is structured into weekly sessions that tackle each health behavior, interspersed with off weeks; for community engagement, especially in barbershops, to discuss health topics and promote a healthier lifestyle.

Research Team

Guillermo M Wippold

Principal Investigator

University of South Carolina

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Value of a supervised exercise program for the therapy of arterial claudication. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. United States 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. [2022]

4. United States 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. [2010]

5. England pubmed.ncbi.nlm.nih.gov

Fatness and fitness: how do they influence health-related quality of life in type 2 diabetes mellitus? [2022]

6. England pubmed.ncbi.nlm.nih.gov

Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Practical suggestions for harms reporting in exercise oncology: the Exercise Harms Reporting Method (ExHaRM). [2023]

8. Canada pubmed.ncbi.nlm.nih.gov

Researchers' perspectives on adverse event reporting in resistance training trials: a qualitative study. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Exercise: friend or foe? [2022]

10. United States 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. [2015]

11. United States pubmed.ncbi.nlm.nih.gov

"It is our exercise family": experiences of ethnic older adults in a group-based exercise program. [2021]

12. England pubmed.ncbi.nlm.nih.gov

The long-term effects of progressive resistance training on health-related quality in older adults. [2019]

13. Ireland pubmed.ncbi.nlm.nih.gov

Wellness in community living adults: the Weigh to Life program. [2015]

14. Australia pubmed.ncbi.nlm.nih.gov

Thai Yoga improves physical function and well-being in older adults: A randomised controlled trial. [2018]

15. Switzerland pubmed.ncbi.nlm.nih.gov

An Active Retirement Programme, a Randomized Controlled Trial of a Sensorimotor Training Programme for Older Adults: A Study Protocol. [2023]