Exercise Program for Aging

Overseen By Joseph Mikels, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: DePaul University

Disqualifiers: Joint injections, Recent surgery, Arthritis, Uncontrolled diabetes, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify effective methods to encourage older adults to exercise regularly, which can benefit physical, cognitive, and mental health and may protect against Alzheimer's disease and other dementias. The study focuses on how positive feelings and social interactions can motivate older adults to start and maintain an exercise routine. Participants will join the "Fit and Strong" program, which includes exercises for flexibility, aerobics, and strength, with sessions three times a week for eight weeks. This trial may suit older adults who are currently not very active, experience dizziness or unsteadiness while moving, and have a history of high blood pressure. As an unphased trial, this study offers a unique opportunity for participants to contribute to research that could enhance the quality of life for older adults.

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 mentions that your physician will be contacted for clearance if you have certain health conditions, but it doesn't say anything about stopping medications.

What prior data suggests that this exercise program is safe for older adults?

Research has shown that the Fit and Strong! program is safe for older adults. Studies have found that this program, which includes exercises like aerobics and strength training, improves strength and movement without causing harm. It has been particularly beneficial for people with arthritis, reducing pain and stiffness while encouraging more physical activity.

Exercise is generally safe, and the Fit and Strong! program supports this by demonstrating benefits like reduced fatigue and depression. Participants often feel better and have more energy. Overall, evidence suggests that the Fit and Strong! program is well-received and offers many health benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Fit and Strong" exercise program because it offers a comprehensive and structured approach to improving physical activity among older adults. Unlike standard exercise recommendations that can be vague, this program provides specific, measurable goals with a focus on flexibility, aerobic capacity, and strength. By incorporating low-impact aerobic routines and progressive strength training, it aims to enhance self-efficacy, making it easier for participants to maintain physical activity beyond the program. Additionally, the use of physical activity logs allows for personalized tracking and increased motivation, which can lead to better long-term health outcomes.

What evidence suggests that this exercise program is effective for aging?

Research shows that Fit and Strong!, the program under study in this trial, improves physical health in older adults. Studies have found it significantly boosts leg strength and mobility, with benefits lasting up to 18 months. Participants report less stiffness and joint pain, easing daily activities. Fit and Strong! promotes regular physical activity by boosting confidence in exercising and reducing barriers to staying active. The program is particularly beneficial for those with mild to moderate osteoarthritis, providing a balanced approach to enhancing strength and flexibility. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for older adults who can potentially benefit from exercise to improve physical, cognitive, and mental health. Participants must have previously joined Experiment 4A and meet the Fit & Strong! study criteria. They need physician clearance if they have high blood pressure or experience certain symptoms during physical activity.

Inclusion Criteria

Participants must comply with the exclusion protocol implemented in earlier Fit & Strong! studies, and their physician will be contacted for further health clearance if they report having high blood pressure or experiences of dizziness, lightheadedness, chest pain/pressure while physically active

To be eligible for Experiment 4B, you must have already taken part in Experiment 4A.

Exclusion Criteria

Experiment 4B: Participants who did not participate in Experiment 4A are not eligible to participate in Experiment 4B.

Experiment 4A: Participants will be excluded for joint steroid injections within 3 months, knee or hip surgery within the previous 6 months or next year, rheumatoid arthritis or other systemic inflammatory arthritis, or uncontrolled diabetes. The participant's physician will be contacted for clearance if they have a history of high blood pressure, or experience dizziness, lightheadedness, or chest pain or pressure during physical activities. Physicians will also be contacted if participants indicate that they fall, feel unsteady, or use an assistive walking or standing device.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Experiment 1

Laboratory-based experiment examining affective reactions, evaluations, and behavioral intentions in response to framed messages

4-6 weeks

Experiment 2

Field-based experiment examining affective reactions, evaluations, and behavioral intentions when people exercise alone or with another person

4-6 weeks

Experiment 4A & 4B

Participants attend 3 sessions/week for 8 weeks in an evidence-based fitness program, Fit & Strong!, focusing on flexibility, aerobics, strengthening, and physical activity logs

8 weeks

3 sessions per week

Follow-up

Participants are monitored for continued physical activity and social and emotional influences one year after the program ends

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Fit and Strong

Trial Overview The 'Fit and Strong' intervention is being tested to see how shared interpersonal positivity affects decision-making in exercising among older adults. The study explores motivational factors relevant at different stages of behavior change.

How Is the Trial Designed?

Group I: Experiment 4A & 4B Experimental Treatment 1 Intervention

Participants will attend for 3 sessions/week for 8 weeks. Instructors will conduct classes and maintain participant attendance records. Exercise components include flexibility, aerobics, strengthening, and physical activity logs. Classes begin and end with 10-minute warmups and cool downs. Participants are taught low-impact aerobic routines to maximize self-efficacy for physical activity maintenance after the program. This will include fitness walking that will progress from each participant's maximum capacity to the goal of 20 minutes of sustained walking. Participants will be instructed on how to gauge their exercise intensity and physical exertion. The strengthening focus of the program will improve independent functioning by targeting lower extremity strength with a graded, task-specific approach. Resistance will be progressively increased over the course of the program by adding weight. At the end of each exercise session, participants will log physical activity.

Who Is Running the Clinical Trial?

DePaul University

Lead Sponsor

Trials

9

Recruited

8,500+

Published Research Related to This Trial

Strength-training exercises, performed regularly (2 to 3 days per week), can effectively combat sarcopenia in older adults by building muscle strength and mass, preserving bone density, and enhancing overall vitality.

These exercises not only reduce the risk of osteoporosis but also alleviate symptoms of chronic diseases like heart disease and type 2 diabetes, while improving sleep and reducing depression, highlighting their broad health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The benefits of strength training for older adults. Seguin, R., Nelson, ME.[2022]

In a study involving 71 older hospitalized patients, those who participated in progressive resistance strength training showed significant improvements in walking speed and mobility tasks compared to the control group, indicating potential benefits of this training method.

While both groups improved in various functional measures, the treatment group demonstrated greater overall improvements, suggesting that adding strength training to standard care may enhance rehabilitation outcomes for older patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does progressive resistance strength training as additional training have any measured effect on functional outcomes in older hospitalized patients? A single-blinded randomized controlled trial. Tibaek, S., Andersen, CW., Pedersen, SF., et al.[2019]

Resistance training (RT) is the only non-drug method proven to effectively counteract age-related declines in muscle mass, strength, and power, while also reducing risks of various health issues like cardiovascular disease and depression.

Minimal-dose RT strategies, which involve lower training volumes and can be performed with minimal equipment, are effective in improving strength and functional ability, making it easier for more people to participate and potentially enhancing overall health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimal-Dose Resistance Training for Improving Muscle Mass, Strength, and Function: A Narrative Review of Current Evidence and Practical Considerations. Fyfe, JJ., Hamilton, DL., Daly, RM.[2022]

Citations

1. fitandstrong.uic.edu fitandstrong.uic.edu/about-fit-strong/evidence/

Fit & Strong! Works - Here's the Evidence Fit & Strong! reverses this trend in groups at high risk for disability at enrollment and shows significant improved LE strength and mobility out to 18 months.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3981882/

Fit and Strong! Plus: Design of a Comparative Effectiveness ... Fit and Strong! has demonstrated improvements in LE joint stiffness, pain and function as well as LE strength and mobility up to 24 months and has been ...

3. ncoa.org ncoa.org/article/evidence-based-program-fit-strong/

Evidence-Based Program: Fit & Strong! Published findings demonstrate Fit & Strong! significantly improves engagement and maintenance of PA. If people exercise other good things ...

4. ruralhealthinfo.org ruralhealthinfo.org/project-examples/726

Rural Project Summary: Fit & Strong!® Results: Participants gained confidence with increased exercise, lessened stiffness, improved joint pain and improved lower extremity strength and mobility.

5. acl.gov acl.gov/sites/default/files/programs/2017-03/Fit_and_Strong.pdf

Fit and Strong! Fit and Strong! is a multicomponent physical activity and behavior change program for older adults with mild to moderate osteoarthritis in their lower ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4410419/

Fit & Strong! Promotes Physical Activity and Well-Being in ... Physical activity reduces fatigue and depression while improving quality of life in cancer survivors. Exercise is generally considered safe ...

7. ebccp.cancercontrol.cancer.gov ebccp.cancercontrol.cancer.gov/programDetails.do?programId=2521570

Fit & Strong! | Evidence-Based Cancer Control Programs ... The study showed an increase in exercise and decreases in pain and stiffness. Program Highlights. Purpose: Designed to increase physical activity among adults ( ...