Arm-in-Arm Gait Training Trial (AAGaTT)

Philippe Terrier

Status: Enrolling

Conditions: Healthy Aging

Treatments: Other: Arm-in-arm gait training; Other: Normal gait training

Study type: Interventional

Funder types: Other

Identifiers

NCT05627453

2022-01452

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 132 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. 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.

2. Younger Participant

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

Exclusion criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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132 participants in 2 patient groups

Normal gait training

Active Comparator group

Description:

The gait training session will consist in 30 min walking side-by-side. If any, the session will take place along an indoor circuit to avoid unfavorable weather conditions. The participants will walk side by side without contact and without instructions about gait synchronisation. They will have to agree on a comfortable pace for the older participant. The gait training session will be repeated three times a week for four weeks. The last session of each week will also include an assessement of gait quality.

Treatment:

Other: Normal gait training

Arm-in-arm gait training

Experimental group

Description:

The gait training session will consist in 30 min walking side-by-side. If any, the session will take place along an indoor circuit to avoid unfavorable weather conditions. The participants will be asked to walk arm-in-arm while synchronizing their steps. They will have to agree on a comfortable pace for the older participant. The gait training session will be repeated three times a week for four weeks. The last session of each week will also include an assessement of gait quality.

Treatment:

Other: Arm-in-arm gait training