Functional Resistance Training for Limited Mobility

(FASTNIA Trial)

Recruiting at 1 trial location

Overseen By Jordan Kurth, Ph.SD.

Age: 65+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Milton S. Hershey Medical Center

Disqualifiers: Chest pain

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 24

Duration: 12 months

360 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether functional resistance training, known as Functional Activity Strength Training, can improve mobility in older adults who struggle to walk a quarter mile. Participants will begin the training either immediately or after 12 months. The training consists of five minutes of daily resistance exercises, guided by video coaching over a year. Eligible participants are those who find walking a quarter mile difficult. As a Phase 2/3 trial, this research measures the treatment's effectiveness in an initial group and represents the final step before FDA approval, offering participants a chance to contribute to groundbreaking mobility solutions.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this functional resistance training is safe for older adults?

Research has shown that the exercise program in this trial, known as functional training, can improve mobility in older adults. A review of 13 studies found that this type of exercise can ease daily activities.

These studies reported no negative side effects from the training, suggesting it is generally safe and well-tolerated. However, following the guidance of trained professionals during these programs is crucial to avoid any risks.

In summary, based on past research, functional resistance training appears to be a safe method to enhance strength and mobility in older adults. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for limited mobility?

Researchers are excited about Functional Activity Strength Training for limited mobility because it offers a unique approach compared to traditional physical therapy and exercise regimens. Unlike typical treatments that often require in-person sessions and extensive equipment, this method uses daily, short resistance training exercises supported by video coaching, making it more accessible and convenient for participants. This innovative delivery method empowers individuals with limited mobility to engage in consistent strength training at home, potentially leading to improved functional outcomes and greater independence.

What evidence suggests that functional resistance training is effective for improving lower extremity performance and walking ability?

Research has shown that functional resistance training can help older adults move better and gain strength. A review of 13 studies found that this type of exercise improves movement and eases daily activities. Another study found that participants increased strength in various exercises without special equipment. Exercise that builds muscle power is both safe and effective for boosting strength and muscle size. In this trial, participants in the Functional Activity Strength Training arm will perform 5 minutes of functional resistance training daily, supported by 24 video coaching sessions over 12 months. Participants in the Delayed Treatment arm will receive the intervention after 12 months. Overall, functional training positively impacts muscle strength, balance, and daily activities, supporting its potential to enhance mobility. ^{1 2 6 7 8}

Who Is on the Research Team?

Maggie Nellissery, Ph.D.

Principal Investigator

National Institute on Aging (NIA)

Are You a Good Fit for This Trial?

This trial is for older adults who have trouble walking or can't walk a quarter mile. They should not join if they experience chest pain during the Physical Activity Readiness Questionnaire (PAR-Q), which assesses fitness for exercise.

Inclusion Criteria

I struggle or can't walk a quarter mile.

Exclusion Criteria

I experience chest pain during physical activity.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants perform 5 minutes of functional resistance training daily, supported by 24 video coaching sessions over 12 months

12 months

24 video coaching sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Delayed Treatment

Participants in the control group receive the intervention after 12 months

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Functional Activity Strength Training

Trial Overview The study tests whether doing functional resistance training exercises for just five minutes daily over a year improves leg strength and walking in older adults with mobility issues, compared to those who receive delayed treatment.

How Is the Trial Designed?

Group I: Functional Activity Strength TRaining Experimental Treatment 1 Intervention

Participants will perform 5 minutes of functional resistance training daily, supported by 24 video coaching sessions over 12 months.

Group II: Delayed Treatment Active Control 1 Intervention

Participants will receive the intervention after 12 months.

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Recruited

2,873,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

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-restricted resistance training (BFR-RT) is safe and effective for improving systolic blood pressure in patients with coronary artery disease (CAD), showing a significant reduction of 10 mm Hg after 8 weeks of training.

BFR-RT combined with aerobic training did not negatively affect hemostatic markers, indicating it can be a beneficial addition to cardiac rehabilitation programs without adverse effects on blood clotting factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hemodynamic and Hemostatic Response to Blood Flow Restriction Resistance Exercise in Coronary Artery Disease: A Pilot Randomized Controlled Trial. Kambič, T., Novaković, M., Tomažin, K., et al.[2021]

In a review of 121 trials involving 6700 older adults, most adverse events related to progressive resistance strength training were musculoskeletal issues like muscle strains and joint pain, particularly in participants with pre-existing health conditions or those engaging in high-intensity training.

Adverse events were often underreported, highlighting the need for clearer definitions and consistent reporting in future studies to better inform practitioners about the risks and benefits of strength training in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events reported in progressive resistance strength training trials in older adults: 2 sides of a coin. Liu, CJ., Latham, N.[2010]

Participants with chronic health conditions expressed that adverse events (AEs) from resistance training (RT) significantly impact their willingness to engage in future exercise, highlighting the importance of understanding both the risks and benefits of RT.

The study identified that personal experiences, health conditions, and the environment in which RT occurs influence perceptions of safety and participation, suggesting that better communication about the risks of AEs is essential to encourage RT among individuals with chronic health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring participants' perspectives on adverse events due to resistance training: a qualitative study. El-Kotob, R., Pagcanlungan, JR., Craven, BC., et al.[2023]

Resistance training (RT) significantly reduces all-cause mortality and the incidence of cardiovascular disease while improving physical functioning in adults, based on an analysis of 11 systematic reviews involving over 382,000 participants.

Although adverse events were not consistently reported, serious adverse events related to RT were uncommon, suggesting that the benefits of resistance training outweigh the potential harms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resistance training and health in adults: an overview of systematic reviews. El-Kotob, R., Ponzano, M., Chaput, JP., et al.[2021]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11664925/

Is functional training functional? a systematic review of its ... A systematic review of 13 studies in 2014 showed that functional training improved older adults' mobility and reduced their ADL disability [14].

2. frontiersin.org frontiersin.org/journals/rehabilitation-sciences/articles/10.3389/fresc.2022.836655/full

Mobility Disability and Exercise: Health Outcomes of an ... Strength significantly increased across all four strength exercises regardless of equipment used. Increases in strength for all exercises ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10828358/

Functional mobility and physical fitness are improved ... Physical exercise, that develops muscle power, has been shown to be effective and safe in improving strength and muscle mass as well as ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1568163711000699

Review Effects of physical exercise therapy on mobility ... The results show that physical exercise therapy has a positive effect on mobility (SMD final value: 0.18; 95% CI: 0.05, 0.30; SMD change value: 0.82; 95% CI: ...

5. eurapa.biomedcentral.com eurapa.biomedcentral.com/articles/10.1007/s11556-014-0144-1

Systematic review of functional training on muscle strength ... Results show beneficial effects on muscle strength, balance, mobility, and activities of daily living, particularly when the training content ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9397740/

Health Outcomes of an Accessible Community-Based Center This study provides evidence that an individualized CBEP can significantly improve upper extremity strength and decrease pain for PwMD, as well ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0197457217302057

The impact of mobility limitations on health outcomes ... Higher levels of mobility limitations were strongly associated with negative health outcomes. Mobility-enhancing interventions could promote successful aging.

8. mdpi.com mdpi.com/2075-4663/11/6/116

High-Intensity Functional Training: Perceived ... Surveys and interviews were designed to examine changes to perceived health, and the elements of HIFT that promote sustained participation.