Learning From Falling: Perturbation-based Training to Prevent Falls in Older Adults

NCT04770103 | Completed DMC

• 1 other identifier: DG020320
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will evaluate the difference between a commonly accepted paradigm of balance training (BT) and a more dynamic and task specific form of balance training, perturbation-based training (PBT) in older adults. BT is a key evidenced based strategy for preventing falls in older adults, however it needs to be regular (2hours/week) and long term (\>6moths) while the average effect is only moderate (24%). The reason for the moderate effect on falls is like to be the non-specific stimulus presented during BT. That is, training tends to be quasi-static and slow and largely based on movements described as strength training. However, when an individual loses balance, they are most often required to implement a rapid and dynamic response. Furthermore, while older adults who are unable to recover balance well have generally lower strength, our recent work has demonstrated that it is not their force producing capability that limits them. Rather it is the ability to access moderate levels of muscular force very rapidly and early in the recovery step that differentiates successful versus unsuccessful recovery of balance. Importantly, the ability to produce an effective and rapid recovery step is predicative of avoiding future real world falls. An emerging fall prevention training regimen is perturbation-based training (PBT). PBT involves rapidly disrupting balance requiring the participant to take rapid steps to recover balance. This is commonly achieved on a laboratory treadmill equipped with a safety harness to prevent actual falls during training. By simulating "real-world" balance challenges such as slips and trips, PBT provides a direct means for learning how to recover balance and avoid falls. It has been demonstrated that with only a few PBT sessions, older adults make rapid and dramatic improvements in balance recovery performance, retain the skills long-term and potentially suffer fewer falls over extended periods. This study builds on the previous published work of the PI that describes the key factors related to differences in balance recovery performance, the neuro-motor coordination strategies used during successful and unsuccessful recovery, and currently unpublished pilot studies indicating the efficacy of PBT. To date studies have not directly compared BT regimes recommended by the American College of Sports Medicine (ACSM) against PBT, nor have they evaluated the influence of training on the incidence of real-world falls. In part this may be because PBT currently requires the use of expensive, laboratory treadmills and as such is not accessible by the average independent, community dwelling older adults. A specific randomized study is required and our overall purpose for this study is to compare the balance recovery performance of older adults following either BT or PBT, evaluate differences in the incidence of real-world falls, and develop a safe, effective and portable device for use in future community PBT training studies. The short-term goals are to determine the effect of PBT versus BT and the neuro-motor mechanism of improved recovery behavior. Aim 1: To evaluate differences in balance recovery behavior in older adults following either balance training (BT) and perturbation-based training (PBT) and the incidence on real-world falls. H1: Balance recovery performance will improve in both BT and PBT groups but will be significantly better in those completing PBT when compared to BT. H2: Improvements in balance recovery behavior will be related to improved coordination and neuro-motor control strategies. H3: Real world loss of balance events will be similar in both BT and PBT but incidence of resulting falls will be lower in the PBT group.

Conditions

Accidental Falls

Keywords

Balance Recovery

Outcome Measures

Primary Outcomes (3)

• Margin of stability

  Margin of stability describes dynamic stability of an individual during stepping. It quantifies the location of the velocity adjusted center of mass compared to the base of support. Positive numbers reflect stability while negative numbers reflect instability. Margin of stability during balance recovery is related to future fall.

  3 months

• Step length

  Difference in the length of the recovery step differentiate individuals who can successfully recover balance compared to those who cannot.

  3 months

• Step time

  Difference in the time take to take a recovery step differentiate individuals who can successfully recover balance compared to those who cannot.

  3 months

Secondary Outcomes (3)

• Fall Incidence

  6 months

• Fear of Falling

  6 months

• Attitude towards exercise

  6 months

Study Arms (2)

Dynamic

EXPERIMENTAL

Participants within the dynamic arm will receive either traditional balance training within ACSM guidelines or Dynamic Step training known as Perturbation based training (PBT). Outcome measures assessed will be Margin of Stability during dynamic step recovery when subjected to a forward loss of balance, along with static postural sway ( a measure of postural control not requiring a step recovery). Participants motivation, mental wellness, attitudes to exercise and fear of falling will be assessed prior to the intervention and 6 months following the intervention.

Behavioral: Balance recovery

Static

EXPERIMENTAL

Participants within the static arm will receive only traditional balance training within ACSM guidelines. The outcome measure within the static arm is limited to static postural sway. Participants motivation, mental wellness, attitudes to exercise and fear of falling will be assessed prior to the intervention and 6 months following the intervention.

Behavioral: Postural Sway

Interventions

Balance recovery BEHAVIORAL

Balance recovery by stepping ascertains the capability of the participant to recover when subjected to a loss of balance in the forward direction. Attitudes towards exercise, fear of falling and mental wellness a psychosocial measures to ascertain the relationship between perceptions and physical capability.

Also known as: Attitudes towards exercise, Fear of falling, Mental Wellness

Dynamic

Postural Sway BEHAVIORAL

Postural sway is a pseudo-static measure of postural control that evaluates a participants balance recovery ability when the perturbation does not require a dynamic step recovery. Attitudes towards exercise, fear of falling and mental wellness a psychosocial measures to ascertain the relationship between perceptions and physical capability.

Also known as: Attitudes towards exercise, Fear of falling, Mental Wellness

Static

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to take part in this study, you must meet all of the following criteria:
• Are aged 60 to 80 years
• Are living in the community
• Are a Non-smoker
• Do not have a recent muscle or joint injury
• Do not have a progressive musculoskeletal condition (arthritis, osteoporosis etc)

You may not qualify if:

• You will not be able to take part in this study if you meet any one of the following criteria:
• If you regularly consume any analgesic or anti-inflammatory drug(s), prescription or non-prescription. If you are unsure about the drugs that you are taking, please ask us.
• You take medication that may make you dizzy or feel unbalanced, please consult with us regarding any prescribed medication you may be taking. Depending on the medication we may need screen you out of the study or ask that you to obtain clearance from your physician prior to being accepted into the study.
• A history of bone, joint, nerve, muscle problems or a current injury and are unable to obtain physician approval. This includes joint replacements or reconstructive surgery in the ankle, hip or knee joints.
• If you have had a stroke or have a heart condition for which moderate to vigorous exercise is contraindicated.
• If your doctor has told you that you should not do exercise.

Sponsors & Collaborators

• Montana State University: lead

Study Sites (1)

Montana State University, Department of Health and Human Development

Bozeman, Montana, 59717, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: February 25, 2021
• Study Start: January 11, 2021
• Primary Completion: April 30, 2022
• Study Completion: June 30, 2022
• Last Updated: May 10, 2023

Record last verified: 2023-05

Locations

US (1)