Arm-in-Arm Gait Training Trial

Официальное название

Helping Older People Recover Walking Abilities Through Arm-in-armg Gait Training: a Randomized Controlled Trial

Обзор

The AAGaTT study, is a monocentric, two-arm, open-label, randomized controlled trial. The objective is to assess the efficacy of an arm-in-arm walking program for older people at risk of falling. Gait training imply that the older participants must walk while synchronizing steps with a younger partner.

Подробное описание

A high level of physical activity is the cornerstone of healthy aging. Falls are a major issue in elderly population, and exercising can mitigate their occurrence. However, the type of exercise-and the optimal way to deliver it-that maximises efficacy is still unknown. The ideal-most efficient-exercise intervention should have the following characteristics: it should have a specific effect on fall risk mitigation, it should be of sufficient intensity to improve cardiovascular fitness and muscle strength, it should be safe, it should not induce high costs, and it should be sufficiently enjoyable and motivational to induce a high adherence and compliance. The present trial aims at testing an innovative exercise intervention that may exhibit all these advantages.

The intervention will consist in four weeks of 30min arm-in-arm synchronized gait training three times a week. Convincing evidence from the literature supports the use of rhythmic externals cues, either auditory or visual, to improve the efficacy of gait training for fall risk reduction in seniors. Synchronizing gait with a younger partner may bring further benefits.

We will focus on clinically relevant outcomes to highlight potential benefits of the intervention in term of gait quality, balance, fall risk mitigation, physical activity level, mood, and well-being.

Gait quality will be assessed through two inertial sensors attached to the low back and foot. Six gait assessement sessions are planned: at baseline (before randomization), at the end of each training week, and at week 7 (follow-up). Participants will walk at their preferred speed over 200m.

We will also include functional tests and self-filled questionnaires to evaluate participant's abilities and mood.

Falls occuring within 18 months after inclusion will be tracked via an online questionnaire every three months.

We will assess the superiority of arm-in-arm gait training compared to standard walking (without gait synchronisation) via a randomized-controlled design. The perception of the intervention by elderly participants will be explored via a qualitative analysis.

Вмешательства

• Другое Arm-in-arm gait training
  An older adult walk side-by-side, arm-in-arm with a younger adult while synchronizing steps.
• Другое Normal gait training
  An older adult walk side-by-side, without contact, with a younger adult without step synchronization.

Первичные конечные точки

• Walking speed [Срок оценки: Week 4]

Вторичные конечные точки (12)

• Walking speed [Срок оценки: Baseline]
• Walking speed [Срок оценки: Week 1]
• Walking speed [Срок оценки: Week 2]
• Walking speed [Срок оценки: Week 3]
• Walking speed [Срок оценки: Week 7 (follow-up)]
• Average step frequency [Срок оценки: Baseline]
• Step frequency [Срок оценки: Week 1]
• Step frequency [Срок оценки: Week 2]
• Step frequency [Срок оценки: Week 3]
• Step frequency [Срок оценки: Week 4]
• Step frequency [Срок оценки: Week 7 (follow-up)]
• Step length [Срок оценки: Baseline]

Критерии участия

Критерии включения

• Older Participant

• Older than 70 years old
• Able to walk continuously during 15 minutes without walking aids.
• Must have experienced a fall during the last year before the recruitment.
• Health certificate that attests no contraindication to walking
• No severe gait disorders from orthopedic or neurologic origins (such as lower-limb amputation or severe hemiparesis). Mild gait abnormalities (for example, mild limping due to knee arthritis, or slight gait asymmetry due to limited hemiparesis) will be tolerated.
• Younger Participant

• Older than 18 years old but younger than 40 years old.
• No severe gait disorders from musculoskeletal or neurologic origin.

Критерии исключения

• Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc.;
• Inability or contraindications to undergo the investigated intervention.
• Vulnerable persons, in sense of swiss Human Research Act art. 21-24.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Швейцария · 1 центр

• Haute-Ecole Arc Santé — Neuchâtel

Публикации

• Ghai S, Ghai I, Effenberg AO. Effect of Rhythmic Auditory Cueing on Aging Gait: A Systematic Review and Meta-Analysis. Aging Dis. 2018 Oct 1;9(5):901-923. doi: 10.14336/AD.2017.1031. eCollection 2018 Oct. PMID 30271666
• Van Abbema R, De Greef M, Craje C, Krijnen W, Hobbelen H, Van Der Schans C. What type, or combination of exercise can improve preferred gait speed in older adults? A meta-analysis. BMC Geriatr. 2015 Jul 1;15:72. doi: 10.1186/s12877-015-0061-9. PMID 26126532
• Sherrington C, Fairhall NJ, Wallbank GK, Tiedemann A, Michaleff ZA, Howard K, Clemson L, Hopewell S, Lamb SE. Exercise for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2019 Jan 31;1(1):CD012424. doi: 10.1002/14651858.CD012424.pub2. PMID 30703272
• Almurad ZMH, Roume C, Blain H, Delignieres D. Complexity Matching: Restoring the Complexity of Locomotion in Older People Through Arm-in-Arm Walking. Front Physiol. 2018 Dec 4;9:1766. doi: 10.3389/fphys.2018.01766. eCollection 2018. PMID 30564149
• Terrier P, Le Carre J, Connaissa ML, Leger B, Luthi F. Monitoring of Gait Quality in Patients With Chronic Pain of Lower Limbs. IEEE Trans Neural Syst Rehabil Eng. 2017 Oct;25(10):1843-1852. doi: 10.1109/TNSRE.2017.2688485. Epub 2017 Mar 28. PMID 28368823
• Terrier P, Reynard F. Maximum Lyapunov exponent revisited: Long-term attractor divergence of gait dynamics is highly sensitive to the noise structure of stride intervals. Gait Posture. 2018 Oct;66:236-241. doi: 10.1016/j.gaitpost.2018.08.010. Epub 2018 Aug 14. PMID 30212783
• Bohannon RW, Williams Andrews A. Normal walking speed: a descriptive meta-analysis. Physiotherapy. 2011 Sep;97(3):182-9. doi: 10.1016/j.physio.2010.12.004. Epub 2011 May 11. PMID 21820535
• Gigonzac M, Terrier P. Restoring walking ability in older adults with arm-in-arm gait training: study protocol for the AAGaTT randomized controlled trial. BMC Geriatr. 2023 Sep 6;23(1):542. doi: 10.1186/s12877-023-04255-9. PMID 37674129

Идентификаторы

NCT: NCT05627453 · 2022-01452

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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