Exercise Programs for Limited Mobility

(TIME Trial)

Overseen By Chris Sciamanna, MD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Milton S. Hershey Medical Center

Disqualifiers: Chest pain, Cognitive impairment, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

620 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two home-based exercise programs to determine which better improves leg function in older adults with limited mobility. The FAST (Functional Activity Strength Training) program involves a brief daily strength training routine with personalized coaching. The other program, Band Together, consists of a 45-minute group exercise held three times a week over Zoom. Researchers aim to discover if the daily FAST program, especially with added motivation techniques, encourages more consistent use and effort than the group sessions. Suitable candidates for this trial are individuals aged 65 or older who struggle to walk a quarter mile and have internet access. As an unphased trial, this study allows participants to contribute to innovative research that could enhance mobility solutions 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.

What prior data suggests that these exercise programs are safe for older adults with limited mobility?

Research has shown that exercise programs like Band Together and FAST are generally safe for older adults. Band Together, similar to programs offered by Silver Sneakers, includes exercises to build strength and improve balance. Studies indicate that these exercises help older adults move better without causing major side effects.

FAST, which stands for Functional Activity Strength Training, focuses on resistance exercises using weights or bands. Research shows that this type of training helps older adults move more easily and reduces difficulties with daily activities. Most people find it manageable.

Both programs often use techniques like setting goals and tracking progress to help participants stick with the exercises. These methods are widely used and safe.

In summary, both Band Together and FAST use proven methods that are safe and beneficial for older adults seeking to improve their mobility. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the exercise programs under study for individuals with limited mobility because they explore new ways to enhance adherence and effectiveness. The Band Together (BT) and Functional Activity Strength Training (FAST) programs incorporate behavior change techniques like goal setting, self-monitoring, and personalized feedback to boost motivation and consistency in participants. Unlike current standard physical therapy options, these programs are delivered remotely via Zoom or personalized coaching, making them accessible and potentially more engaging for individuals. By integrating these innovative approaches, researchers hope to discover methods that improve outcomes and quality of life for those with limited mobility.

What evidence suggests that this trial's exercise programs could be effective for improving leg function in older adults with limited mobility?

Research shows that the Band Together program, similar to Silver Sneakers, helps older adults improve mobility through strength and balance exercises. One study found that these group exercises significantly enhance leg strength and reduce mobility issues. In this trial, participants may receive the Band Together program with or without additional behavior change techniques.

The FAST program, which uses functional resistance training, has helped older adults move more easily and lower their risk of falling. Studies suggest that these exercises improve physical abilities and reduce the fear of falling. Participants in this trial may receive the FAST program with or without behavior change techniques.

Both Band Together and FAST, when combined with techniques like setting goals and tracking progress, effectively encourage regular exercise. These methods are linked to increased physical activity, leading to better movement abilities. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals aged 65 or older who have trouble walking and can access the internet. Participants must be vaccinated against COVID-19 and not planning to move, undergo surgery, or join other physical activity research within a year. Those with chest pain during exercise or cognitive impairment cannot join.

Inclusion Criteria

I am 65 years old or older.

I have received the COVID vaccine.

Access to the Internet

Exclusion Criteria

I have difficulty with memory or thinking clearly.

Participating in another research project involving physical activity, falls or weight loss

I experience chest pain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to either the FAST or BAND TOGETHER exercise programs, with FAST being a daily home-based strength training program and BAND TOGETHER being a thrice-weekly group exercise program over Zoom.

12 months

Monthly virtual check-ins

Follow-up

Participants are monitored for safety, effectiveness, and adherence to the exercise programs, with assessments of walking ability, balance, and leg strength.

4 weeks

Stakeholder Consultation

Stakeholders, including patients and healthcare providers, are consulted to provide feedback and help make decisions throughout the study.

Ongoing throughout the study

What Are the Treatments Tested in This Trial?

Interventions

• Band Together
• Behavioral Change Technique
• FAST (Functional Activity Strength Training)

Trial Overview The TIME trial compares two home-based exercise programs: FAST (focused on strength training) and BAND TOGETHER (similar to Silver Sneakers with strength, balance, aerobic exercises). The goal is to see if FAST leads to better leg function by promoting consistency and effort in workouts.

How Is the Trial Designed?

Group I: FAST-BCT Experimental Treatment 1 Intervention

FAST exercise intervention without behavior change techniques applied. Daily exercise intervention including functional resistance training and personalized coaching.

Group II: FAST+BCT Experimental Treatment 2 Interventions

FAST exercise intervention with behavior change techniques applied. Daily exercise intervention including functional resistance training and personalized coaching with added reminders, education, goal setting, self monitoring, and feedback to encourage adherence and effort.

Group III: BT+BCT Active Control 2 Interventions

Band Together exercise intervention with behavior change techniques applied. 3 times weekly group exercise intervention held over Zoom featuring strength and balance exercises for 45 minutes with added reminders, education, goal setting, self monitoring, and feedback to encourage adherence and effort.

Group IV: BT-BCT Active Control 1 Intervention

Band Together exercise intervention without behavior change techniques applied. 3 times weekly group exercise intervention held over Zoom featuring strength and balance exercises for 45 minutes.

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Recruited

2,873,000+

Published Research Related to This Trial

Exercise resistance bands, commonly used for home workouts during the COVID-19 pandemic, can pose serious injury risks, including open skull fractures and complex eye injuries, as demonstrated in two case reports.

The first case involved a patient with a skull fracture from a recoiling band, while the second case involved ocular trauma from a tearing band, highlighting the need for caution when using these fitness tools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Resistance Band induced injuries during Covid 19 Pandemic Lockdown Training. Heyn, J., Strohm, P., Schöffl, V.[2023]

In a study involving 12 women, blood flow restriction (BFR) during resistance exercise showed similar neuromuscular fatigue responses for both a high-repetition (BFR-75) and a sets-to-failure (BFR-F) approach, indicating that both methods can effectively stimulate muscle adaptation.

The research found that muscle activation, measured by surface electromyography (sEMG), increased significantly during the first three sets of exercise but plateaued afterward, suggesting that optimal muscle engagement occurs early in the workout, regardless of the BFR method used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromuscular Responses to Failure vs Non-Failure During Blood Flow Restriction Training in Untrained Females. Proppe, CE., Aldeghi, TM., Rivera, PM., et al.[2023]

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]

A 12-week low-load resistance exercise program with blood flow restriction (BFR) significantly improved mechanical muscle function and gait speed in a patient with sporadic inclusion body myositis (sIBM).

The patient experienced a 19% increase in maximal horizontal gait speed and 38-92% improvements in various measures of muscle function, indicating that BFR training is a well-tolerated and effective intervention for enhancing physical capabilities in sIBM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of blood-flow-restricted resistance training on muscle function in a 74-year-old male with sporadic inclusion body myositis: a case report. Jørgensen, AN., Aagaard, P., Nielsen, JL., et al.[2022]

A 6-month resistance exercise program using elastic bands significantly improved knee and hip extension strength in 89 functionally limited elders aged 60 to 89, with increases of 16.7% and 20.5%, respectively.

Resistance training also showed trends towards improved lifting performance, suggesting that enhanced leg muscle power may lead to better functional outcomes in lifting tasks for disabled elders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lower-limb extensor power and lifting characteristics in disabled elders. Dancewicz, TM., Krebs, DE., McGibbon, CA.[2019]

Blood flow restriction training (BFRT) was safely applied to two female athletes with shoulder pain, resulting in significant improvements in shoulder function, range of motion, and muscle strength after 16 to 22 treatment sessions.

The study suggests that BFRT could be an effective addition to traditional rehabilitation methods for managing subacromial pain, although further research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood Flow Restriction Training for Subacromial Pain: Two Case Reports. Miller, M., Zeppieri, G., Farmer, KW., et al.[2023]

A community-based functional power training (FPT) program significantly improved physical function in frail older adults compared to usual activities, as shown by better results in the Short Physical Performance Battery test after 12 weeks.

The FPT program was successfully implemented in local senior centers, demonstrating good reach and effectiveness, making it a feasible intervention for enhancing the physical capabilities of frail older adults in their neighborhoods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Community-Delivered Functional Power Training Program for Frail and Pre-frail Community-Dwelling Older Adults: a Randomized Controlled Study. Tou, NX., Wee, SL., Seah, WT., et al.[2022]

A study involving 25 high school weightlifters showed that a practical blood flow restriction (BFR) training program significantly increased lower-body strength, specifically in the group using light weights with BFR, after 6 weeks of training.

In contrast, traditional high-load training did not result in significant strength gains, indicating that BFR training can be an effective alternative for enhancing strength in adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Practical Blood Flow Restriction Training on Adolescent Lower-Body Strength. Luebbers, PE., Witte, EV., Oshel, JQ., et al.[2019]

A 62-year-old woman with COPD showed significant improvements in lower limb strength (up to 521% for knee extensors) and functional exercise capacity after undergoing low-load blood flow restriction strength training (LL-BFRT) followed by high-load strength training, indicating that LL-BFRT can effectively prepare patients for more intense rehabilitation.

The patient experienced no adverse events during the training, suggesting that LL-BFRT is a safe and well-tolerated intervention that can enhance the effectiveness of pulmonary rehabilitation for individuals with COPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood-Flow-Restricted Strength Training Combined With High-Load Strength and Endurance Training in Pulmonary Rehabilitation for COPD: A Case Report. Kohlbrenner, D., Aregger, C., Osswald, M., et al.[2021]

Both dynamic and static band exercises significantly improved physical abilities and muscle topography in elderly females over a 12-week period, as measured by various physical tests and Moire measurement equipment.

Dynamic band exercises led to greater improvements compared to static exercises, suggesting that they may be more effective for enhancing physical fitness in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of elastic band exercises on physical ability and muscular topography of elderlyfemales. Lee, JW., Kim, SB., Kim, SW.[2020]

Low-load exercise training with blood flow restriction (BFR) has been shown to significantly increase muscle strength in clinical musculoskeletal rehabilitation, with a moderate effect size based on a systematic review of 20 studies involving various patient populations.

BFR training is more effective and tolerable than traditional low-load training, suggesting it could be a valuable rehabilitation tool, although it is less effective than heavy-load training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood flow restriction training in clinical musculoskeletal rehabilitation: a systematic review and meta-analysis. Hughes, L., Paton, B., Rosenblatt, B., et al.[2022]

Blood flow-restricted resistance (BFRR) training is effective for improving muscle strength and size while applying less mechanical stress, making it a popular rehabilitation method, especially in military settings.

Despite its benefits, BFRR training can lead to serious adverse effects, such as rhabdomyolysis, as demonstrated in a case involving an active duty Soldier who required hospitalization but ultimately made a full recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Case of Rhabdomyolysis Caused by Blood Flow-Restricted Resistance Training. Krieger, J., Sims, D., Wolterstorff, C.[2022]

A resistance-band functional exercise program significantly improved physical fitness and reaction times in older adults (average age 71.76 years), with notable enhancements in grip strength and arm strength compared to a recreational exercise program.

Participants in the functional exercise group showed better cognitive performance, with improvements in simple and choice reaction times, indicating that targeted strength training can enhance both physical and cognitive abilities in healthy older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of Two Different Exercise Programs on Physical Fitness and Cognitive Performance in Active Older Adults: Functional Resistance-Band Exercises vs. Recreational Oriented Exercises. Ponce-Bravo, H., Ponce, C., Feriche, B., et al.[2019]

Citations

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Testing Interventions for Mobility through Exercise (TIME) A randomized trial comparing a novel, brief home-based exercise program and a standard home-based group exercise for older adults with mobility disability.

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Challenges and opportunity in mobility among older adults The key determinants were found to be environmental, physical, cognitive, and psychosocial, which confirms the findings of previous studies.

7. ahrq.gov ahrq.gov/cahps/surveys-guidance/item-sets/mobility/index.html

CAHPS Item Sets for People with Mobility Impairments The CAHPS Item Sets for People with Mobility Impairments ask patients who have mobility impairments about their experiences with care and services.

8. sciencedirect.com sciencedirect.com/science/article/pii/S2590109523000678

Relationship of Age And Mobility Levels During Physical ... Our findings suggest that age and mobility level contribute to outcome prognostication, and can aide in clinical phenotyping and rehabilitative service ...

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Supporting physical activity for mobility in older adults with ... We propose a randomized controlled trial to assess the effect of a physical activity health coaching intervention on mobility in older adults with mobility ...