Effect of Treadmill Perturbation Training on Falls

NCT04733222 | Completed

• 1 other identifier: N-20200089
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

This parallel, randomized, controlled trial aims to quantify the effects of slip- and trip-perturbation training on fall rates collected over 12 months, compared to time-matched treadmill walking, among community-dwelling older adults (≥65 years). A sample size calculation estimated that 140 older community-dwelling older adults (≥65 years) are needed. Following baseline measures, the recruited participants will randomly be assigned to either the perturbation or the walking group. The participants in the perturbation group will be assigned to four perturbation training sessions. The walking group will perform four treadmill walking matching the exercise time of the perturbation training. Assessment of the primary outcome, fall rates, will be conducted continuously in 12 months from randomization. When a fall is reported in the fall calendar, a telephone interview will be conducted to assess the circumstances and consequences (e.g., fall-related fractures, fall-related hospital admissions) of the falls. Moreover, assessment of physical, cognitive, and social-psychological outcomes will be made at baseline, post-test, six-month, and 12-months reassessment.

Conditions

Accidental Fall; Accident Prevention

Keywords

Aged; Aged, 80 and over; Exercise; Perturbation training; Older adults

Outcome Measures

Primary Outcomes (1)

• Fall rate

  Falls are collected by daily recordings in calendar that is returned to the research group monthly

  Continuously for 12 months after the initial three training sessions

Secondary Outcomes (22)

• Proportion of participants with at least one fall

  Continuously for 12 months after the initial three training sessions

• Time to first fall

  Continuously for 12 months after the initial three training sessions

• Fall-related fracture rate

  Continuously for 12 months after the initial three training sessions

• Proportion of participants with at least one fall-related fractures

  Continuously for 12 months after the initial three training sessions

• Number of all-cause fractures

  At the 52-week follow-up

Study Arms (2)

Perturbation training

EXPERIMENTAL

Participants randomized to the treadmill perturbation training will initially perform three sessions performed within a week followed by a "booster"-session after six months.

Other: Perturbation training

Treadmill walking

ACTIVE COMPARATOR

Participants randomized to the walking group will undergo three initial sessions within a week and a "booster"-session after six months.

Other: Treadmill walking

Interventions

Perturbation training OTHER

The treadmill perturbation training will be performed on a computer-controlled treadmill. The perturbation will be induced by fast forward (slip) or backward (trip) accelerations of the treadmill at specific gait cycle timings. The perturbations will be delivered randomly to enhance the unpredictability. A ceiling-mounted body-harness ensures the safety of the participants. Participants will be assigned to three initial sessions of treadmill slip- and trip-perturbation training on two days separated by a week and a "booster"-session after six months. On day 1, participants will first undergo a session 1 with 40 slip perturbations and then a session 2 with 40 trip perturbations. On day 2, participants will undergo a session 3 with 20 slip and 20 trip perturbations in random order. The "booster"-session after six months will be similar to session 3 (20 of each perturbation in random order).

Perturbation training

Treadmill walking OTHER

Participants allocated to the walking group will walk at a self-selected pace on a computer-controlled treadmill for the same amount of time as the treadmill perturbation training participants.

Treadmill walking

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• ≥65 years old
• Community-dwelling
• Able to walk without a walking aid

You may not qualify if:

• Any of the following self-reported conditions: Any orthopedic surgery within the past 12 months, osteoporosis or history of osteoporosis-related fractures (low impact hip, spine, and wrist fracture), or progressive neurological disease (e.g., Parkinson, multiple sclerosis)
• An unstable medical condition that would prevent safe participation
• Severe cognitive impairment (a score \<8 in The Short Orientation-Memory-Concentration Test)
• Current participation in another fall prevention trial

Sponsors & Collaborators

• Aalborg University Hospital: lead
• Aalborg Municipality: collaborator
• Aalborg University: collaborator
• Odense University Hospital: collaborator
• University of Southern Denmark: collaborator

Study Sites (1)

Aalborg Municipality

Aalborg, Denmark

Location

Related Publications (3)

• Norgaard JE, Andersen S, Ryg J, Andreasen J, Oliveira ASC, Stevenson AJT, Danielsen MBB, Jorgensen MG. Perturbation-based balance training of older adults and effects on physiological, cognitive and sociopsychological factors: a secondary analysis from a randomised controlled trial with 12-month follow-up. BMJ Open. 2024 Aug 7;14(8):e080550. doi: 10.1136/bmjopen-2023-080550.

  PMID: 39117404 DERIVED

• Norgaard JE, Andersen S, Ryg J, Stevenson AJT, Andreasen J, Oliveira AS, Danielsen MB, Jorgensen MG. Effect of Treadmill Perturbation-Based Balance Training on Fall Rates in Community-Dwelling Older Adults: A Randomized Clinical Trial. JAMA Netw Open. 2023 Apr 3;6(4):e238422. doi: 10.1001/jamanetworkopen.2023.8422.

  PMID: 37079305 DERIVED

• Norgaard JE, Andersen S, Ryg J, Stevenson AJT, Andreasen J, Danielsen MB, Oliveira ASC, Jorgensen MG. Effects of treadmill slip and trip perturbation-based balance training on falls in community-dwelling older adults (STABILITY): study protocol for a randomised controlled trial. BMJ Open. 2022 Feb 7;12(2):e052492. doi: 10.1136/bmjopen-2021-052492.

  PMID: 35131823 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Jens Eg Nørgaard, MSc

  Aalborg University Hospital and Aalborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD-student, Cand.Scient.

Model Details: After the pre-training tests, participants will be randomly allocated to either the perturation or control group. To produce groups of similar size a permuted block randomization will be used. Allocation concealment will be maintained using random block sizes (4, 6, or 8) and by the randomization code only being available for non-blinded research staff. The perturbation group will undergo three initial training sessions on two days within a week, and a "booster"-session after six months. The active control group will perform treadmill walking at a preferred speed to match the training dose of the perturbations group.

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: February 2, 2021
• Study Start: April 1, 2021
• Primary Completion: November 15, 2022
• Study Completion: November 15, 2022
• Last Updated: February 1, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)