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

Trial Summary

What is the purpose of this trial?

In this study, we will randomly assign 360 older adults to 12 months of 5 minutes per day of functional resistance training or to a delayed treatment control condition, and measure the impact of the training on measures of lower extremity performance and walking ability.

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 data supports the effectiveness of the treatment Functional Activity Strength Training for improving mobility?

Research shows that resistance training, which is a key part of Functional Activity Strength Training, can improve muscle strength and coordination in older adults and those with disabilities. This type of training has been effective in enhancing functional performance in tasks like lifting and improving mobility in conditions such as stroke and cerebral palsy. ^{1 2 3 4 5}

Is functional resistance training safe for people with limited mobility?

Resistance training, including functional resistance training, is generally safe for adults, but adverse events (unwanted side effects) can occur. Serious adverse events are not common, but it's important to have trained supervision and proper guidance to minimize risks. People with chronic health conditions should be aware of potential risks and discuss them with healthcare providers before starting such training. ^{6 7 8 9 10}

How is Functional Activity Strength Training different from other treatments for limited mobility?

Functional Activity Strength Training is unique because it combines resistance exercises with functional tasks, aiming to improve both strength and coordination in everyday activities. This approach is particularly beneficial for older adults and those with limited mobility, as it focuses on enhancing the ability to perform daily tasks more efficiently, unlike traditional resistance training that may not directly target functional improvements. ^{1 2 11 12 13}

Research Team

Maggie Nellissery, Ph.D.

Principal Investigator

National Institute on Aging (NIA)

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

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

Efficacy of resistance and task-specific exercise in older adults who modify tasks of everyday life. [2019]

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

Lower-limb extensor power and lifting characteristics in disabled elders. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Task-oriented progressive resistance strength training improves muscle strength and functional performance in individuals with stroke. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Effectiveness of functional progressive resistance exercise strength training on muscle strength and mobility in children with cerebral palsy: a randomized controlled trial. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Longitudinal comparison of low- and high-velocity resistance training in relation to body composition and functional fitness of older adults. [2019]

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

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

7. Canada pubmed.ncbi.nlm.nih.gov

Resistance training and health in adults: an overview of systematic reviews. [2021]

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

Exploring participants' perspectives on adverse events due to resistance training: a qualitative study. [2023]

9. Canada pubmed.ncbi.nlm.nih.gov

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

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

Hemodynamic and Hemostatic Response to Blood Flow Restriction Resistance Exercise in Coronary Artery Disease: A Pilot Randomized Controlled Trial. [2021]

11. England pubmed.ncbi.nlm.nih.gov

The Impact of Functional Strength Training on Muscle Strength and Mobility in Children with Spastic Cerebral Palsy - A Systematic Review and Meta-Analysis. [2023]

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

A comparison of two 3-week resistance training programmes commonly used in short-term military rehabilitation. [2019]

13. Korea (South) pubmed.ncbi.nlm.nih.gov

Functional resistance training can increase strength, knee torque ratio, and functional performance in elderly women. [2023]