Speed Walking Program for Broken Bones

(RIFLE Trial)

Recruiting at 1 trial location

Overseen By Brian Noehren, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Brian W. Noehren

Disqualifiers: Chronic pain, Brain injury, Amputation, others

Compensation: Varies

Number of Visits: 6

Duration: 19 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate speed high intensity interval training (HIIT) walking program following an orthopedic trauma.

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 data supports the effectiveness of the Speed Walking Program for Broken Bones treatment?

Research shows that exercise programs, including walking and resistance training, can improve strength and walking speed after hip fractures. High-intensity and center-based programs tend to be more effective, suggesting that a structured walking program could help improve recovery. ^{1 2 3 4 5}

Is speed walking or high-intensity interval training safe for humans?

High-intensity interval training (HIIT), which includes speed walking, is generally well-tolerated and considered safe for older adults and those with cardiovascular conditions, with few serious adverse events reported. Most adverse events are minor, such as muscle strains, and safety can be improved by starting with low intensity and gradually increasing it. ^{6 7 8 9 10}

How does the Speed Walking Intervention differ from other treatments for broken bones?

The Speed Walking Intervention is unique because it incorporates high-intensity interval training (HIIT), which is more time-efficient and can improve physical fitness and walking ability, unlike traditional treatments that may not focus on cardiovascular and aerobic capacity improvements. ^{11 12 13 14 15}

Research Team

Brian Noehren, Ph.D.

Principal Investigator

University of Kentucky

Eligibility Criteria

This trial is for English-speaking adults aged 18-50 who've had a femur or tibia fracture fixed with a rod. They must have been working at least part-time before the injury and be able to attend follow-up visits and therapy sessions without an assistive walking device.

Inclusion Criteria

I need surgery for a broken leg bone using a metal rod.

Exclusion Criteria

I cannot attend in-person follow-ups or therapy sessions.

I cannot put weight on my legs due to multiple injuries.

History of schizophrenia, dementia or neurologic disorder with peripheral dysfunction

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a speed HIIT walking program following an orthopedic trauma, focusing on femoral and tibial shaft fractures requiring surgical fixation.

19 weeks

Regular visits for physical therapy and HIIT sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of physical function, return to work rates, and psychosocial responses.

12 months

Periodic assessments at 6 and 12 months

Treatment Details

Interventions

• Speed Walking Intervention
• Standard of Care Physical Therapy Program

Trial Overview The study tests a high-intensity speed walking program against standard physical therapy for those recovering from leg fractures. It aims to see if this type of exercise can improve recovery outcomes after orthopedic trauma.

Participant Groups

Group I: Standard of Care Physical Therapy Program with Speed Walking Intervention Experimental Treatment 2 Interventions

Standard of care will follow best practice. The subjects and their physical therapists will be provided with a standardized set of exercises and guidance on what to cover during skilled physical therapy visits. Additionally, subjects will complete the speed walking intervention. Participants will perform at 2 minute warm up followed by 1 minute of walking at their fastest tolerable speed followed by 2 minutes of active recovery where they will walk at a speed of their choosing. The subjects will perform 4 cycles of this followed by a 2 minute cool down at the end.

Group II: Standard of Care Physical Therapy Program Placebo Group 1 Intervention

Standard of care will follow best practice. The subjects and their physical therapists will be provided with a standardized set of exercises and guidance on what to cover during skilled physical therapy visits.

Who Is Running the Clinical Trial?

Brian W. Noehren

Lead Sponsor

Trials

2

Recruited

120+

U.S. Army Medical Research and Development Command

Collaborator

Trials

296

Recruited

249,000+

Findings from Research

A meta-analysis of 11 randomized controlled trials involving 1068 hip fracture patients found that home-based exercise programs significantly improved leg strength in both the fractured and non-fractured legs, as well as performance on the Six-Minute Walk Test (6MWT).

However, these home exercise programs did not show significant improvements in overall physical health, gait speed, balance, or daily living activities, indicating that while they can enhance specific strength measures, their overall impact on physical function may be limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of home-based exercise programme on physical function after hip fracture: a systematic review and meta-analysis of randomised controlled trials. Chen, B., Hu, N., Tan, JH.[2021]

In a study of 352 hip fracture patients undergoing intensive rehabilitation, 84% were able to recover ambulation by discharge, highlighting the efficacy of rehabilitation in this population.

Higher comorbidity and impaired communication skills on admission were significant predictors of failure to regain ambulation, indicating that these factors should be closely monitored to improve rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of recovering ambulation after hip fracture inpatient rehabilitation. Cecchi, F., Pancani, S., Antonioli, D., et al.[2019]

Body weight-supported treadmill training (BWSTT) was found to be a feasible intervention for improving walking ability in patients recovering from hip fractures, with 51% of eligible patients agreeing to participate and no reported adverse events.

While BWSTT showed promise, future studies need to focus on improving patient compliance and retention, as only 67% of participants returned for follow-up assessments and some patients attended fewer training sessions than recommended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Body weight-supported treadmill training for patients with hip fracture: a feasibility study. Giangregorio, LM., Thabane, L., Debeer, J., et al.[2021]

In a study of 80 older inpatients (average age 81) recovering from hip fractures, both weight-bearing and non-weight-bearing exercise programs led to significant improvements (around 50%) in strength, balance, gait, and overall functional performance over two weeks.

While both exercise types were effective, the non-weight-bearing group showed greater strength gains in hip flexion and abduction, whereas the weight-bearing group had better functional outcomes, such as improved lateral step-ups and reduced need for walking aids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised trial of weight-bearing versus non-weight-bearing exercise for improving physical ability in inpatients after hip fracture. Sherrington, C., Lord, SR., Herbert, RD.[2019]

Progressive resistance training significantly improves muscle strength and gait speed in older adults after hip fracture surgery, with a notable effect size observed immediately after the rehabilitation program (SMD = 0.40).

Higher training intensity and center-based programs are linked to greater improvements in strength and gait speed, suggesting that these factors may enhance rehabilitation outcomes, although the long-term benefits appear limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progressive Resistance Training Program Characteristics in Rehabilitation Programs Following Hip Fracture: A Meta-Analysis and Meta-Regression. Ramadi, A., Ezeugwu, VE., Weber, S., et al.[2022]

In a randomized controlled trial involving 24 patients with acute pulmonary embolism, high-intensity interval training (HIIT) significantly improved exercise capacity (eV˙O2max increased by 65%), lung function (FEV1 improved by 17%), and right ventricular function (RV/LV ratio decreased by 27%) over 8 weeks.

The HIIT program was safe, with all participants tolerating the exercise without serious adverse events, while the control group showed no improvements and even a slight decline in lung function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Intensity Interval Training in Patients with Pulmonary Embolism: A Randomized Controlled Trial. Ghram, A., Jenab, Y., Soori, R., et al.[2023]

High-intensity interval training (HIIT) is as effective, if not more so, than traditional moderate-intensity continuous training (MICT) for patients with cardiovascular disease, based on a systematic review of 23 studies involving 1117 participants.

The safety profile of HIIT in cardiac rehabilitation is promising, with only one major cardiovascular adverse event reported per 17,083 training sessions, indicating that HIIT can be safely implemented in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Intensity Interval Training for Patients With Cardiovascular Disease-Is It Safe? A Systematic Review. Wewege, MA., Ahn, D., Yu, J., et al.[2021]

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]

A 12-week high-intensity interval training (HIIT) program using suspension exercises significantly improved body mass index (BMI) and gait speed in older adults compared to continuous intensity training and a control group, indicating its efficacy in enhancing physical health.

Participants in the HIIT group also experienced notable improvements in quality of life measures, including general health and vitality, suggesting that this exercise regimen can positively impact overall well-being in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suspension Training HIIT Improves Gait Speed, Strength and Quality of Life in Older Adults. Jiménez-García, JD., Martínez-Amat, A., De la Torre-Cruz, MJ., et al.[2022]

A scoping review of 69 studies on high-intensity interval training (HIIT) in older adults found that HIIT protocols are generally well-tolerated and can provide significant health benefits, particularly in improving cardiorespiratory fitness.

Most research has focused on healthy older adults, highlighting a need for larger studies and more investigation into HIIT's effects on older adults with various health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Intensity Interval Training in Older Adults: a Scoping Review. Marriott, CFS., Petrella, AFM., Marriott, ECS., et al.[2021]

A 3-month exergame training program improved walking speed and various gait parameters in older women, particularly at their self-selected walking speed, regardless of whether the exercises were performed at moderate or vigorous intensity.

Participants showed significant improvements in walking speed (from 112.1 cm/s to 124.8 cm/s) and several gait metrics, indicating that exergames can be an effective intervention for enhancing mobility in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Different Exergame Intensity Training on Walking Speed in Older Women. Pitta, A., Pereira, G., Lara, JPR., et al.[2020]

A 30 to 45-day physical training program significantly improved walking distance in 98 out of 105 patients with intermittent claudication, with some achieving 'functional remission' by increasing their walking distance from about 900 m to much greater distances.

The study highlights that while ankle pressures remained unchanged, non-hemodynamic factors, such as psychological motivation and reduced risk factors for atherosclerosis, played a crucial role in the patients' improvements, making exercise training a highly effective non-surgical treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Results of the physiotherapy of arterial disease at the stage of intermittent claudication by programmed efforts training (author's transl)]. Franco, A., Legrand, E., Guidicelli, H., et al.[2008]

A 3-month interval walking program significantly improved peak aerobic capacity in middle-aged sedentary individuals, increasing it from 20.4 to 26.0 mL/kg/min, which indicates better cardiovascular fitness.

The program also led to a reduction in resting systolic blood pressure from 127 to 119 mm Hg, demonstrating that even modest amounts of aerobic exercise can positively impact cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of interval walking on physical fitness in middle-aged individuals. Lalande, S., Okazaki, K., Yamazaki, T., et al.[2013]

High-intensity interval training (HIIT) has been shown to improve walking distances and peak oxygen uptake in patients with intermittent claudication (IC) within just 6 weeks, making it a promising alternative to traditional supervised exercise programs.

Compared to low-intensity exercise, HIIT provides significant benefits in a shorter time frame, suggesting that it could enhance recruitment and adherence rates for patients who struggle with longer exercise programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of high-intensity interval training as an exercise intervention for intermittent claudication. Pymer, S., Palmer, J., Harwood, AE., et al.[2020]

Exercise programs significantly improve pain-free and maximum walking distances in individuals with intermittent claudication, with high-quality evidence from 32 studies involving 1835 participants, showing improvements lasting up to two years.

While exercise did not affect ankle-brachial index (ABI) or reduce mortality and amputation rates, it may enhance quality of life, particularly in physical and mental health domains, compared to usual care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise for intermittent claudication. Lane, R., Harwood, A., Watson, L., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Efficacy of home-based exercise programme on physical function after hip fracture: a systematic review and meta-analysis of randomised controlled trials. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Predictors of recovering ambulation after hip fracture inpatient rehabilitation. [2019]

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

Body weight-supported treadmill training for patients with hip fracture: a feasibility study. [2021]

4. Australia pubmed.ncbi.nlm.nih.gov

A randomised trial of weight-bearing versus non-weight-bearing exercise for improving physical ability in inpatients after hip fracture. [2019]

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

Progressive Resistance Training Program Characteristics in Rehabilitation Programs Following Hip Fracture: A Meta-Analysis and Meta-Regression. [2022]

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

High-Intensity Interval Training in Patients with Pulmonary Embolism: A Randomized Controlled Trial. [2023]

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

High-Intensity Interval Training for Patients With Cardiovascular Disease-Is It Safe? A Systematic Review. [2021]

8. England pubmed.ncbi.nlm.nih.gov

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

9. Germany pubmed.ncbi.nlm.nih.gov

Suspension Training HIIT Improves Gait Speed, Strength and Quality of Life in Older Adults. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

High-Intensity Interval Training in Older Adults: a Scoping Review. [2021]

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

The Effects of Different Exergame Intensity Training on Walking Speed in Older Women. [2020]

12. France pubmed.ncbi.nlm.nih.gov

[Results of the physiotherapy of arterial disease at the stage of intermittent claudication by programmed efforts training (author's transl)]. [2008]

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

Effects of interval walking on physical fitness in middle-aged individuals. [2013]

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

A systematic review of high-intensity interval training as an exercise intervention for intermittent claudication. [2020]

15. England pubmed.ncbi.nlm.nih.gov

Exercise for intermittent claudication. [2023]