Healthy Aging
Conditions
Keywords
fall risk, gait disorder, physical activity, complexity matching
Brief summary
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.
Detailed 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.
Interventions
OTHERArm-in-arm gait training
An older adult walk side-by-side, arm-in-arm with a younger adult while synchronizing steps.
OTHERNormal gait training
An older adult walk side-by-side, without contact, with a younger adult without step synchronization.
Sponsors
Swiss National Science Foundation
Philippe Terrier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
Blinding is not possible due to the nature of the intervention
Intervention model description
The AAGaTT study, is a monocentric, two-arm, open-label, randomized controlled trial. The superiority of arm-in-arm synchronized gait training will be assessed versus standard walking (i.e., walking side-by-side without gait synchronization).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Walking speed | Week 4 | Habitual (preferred) walking speed to cover 200m. Normal values for older men: 1.21m/s -1.32m/s), older women 1.07m/s -1.19m/s). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average step frequency | Baseline | Average number of steps per second while walking at habitual (preferred) speed over 200m. |
| Step frequency | Week 1 | Average number of steps per second while walking at habitual (preferred) speed over 200m. |
| Step length | Baseline | Average step length while walking at habitual (preferred) speed over 200m. |
| Step symmetry | Baseline | Left / right symmetry of the gait assessed via the autocorrelation method. A high value shows a symmetric gait. |
| Fractal index | Baseline | Attentional demand measured via detrended fluctuation analysis (DFA). A high value indicates that less attention is dedicated to control gait (automated gait). |
| Stride regularity | Baseline | Left / right symmetry of the gait assessed via the autocorrelation method. A high value shows a symmetric gait. |
| Gait Stability | Baseline | short-term Local dynamic stability (maximal Lyapunov exponent). A low value shows a more stable gait and a lower risk of fall. |
| Gait attentional demand | Baseline | Attractor complexity index. A high value indicates that less attention is dedicated to control gait (automated gait). |
| Stride time variability | Baseline | Variability of stride (gait cycle) duration over 200m walking. A high value shows a high stride-to-stride variability. |
| Time to perform Timed up-and-go (TUG) test. | Baseline | The Timed Up and Go (TUG) test is a clinical test used to assess balance and walking ability in older populations. The test measures the time a participant take to get up from an armed chair, walk three meters to a line drawn on the floor, turn around and sit back down in the same chair. The time is measured in seconds. The results can be interpreted the following way: * ≤ 10 seconds = normal, good general health * ≤ 20 seconds = good mobility, can go out alone, mobile without a gait aid * \> 30 seconds = difficulties, cannot go outside alone, requires a gait aid |
| Time to perform the Timed up-and-go (TUG) test. | Week 4 | The Timed Up and Go (TUG) test is a clinical test used to assess balance and walking ability in older populations. The test measures the time a participant take to get up from an armed chair, walk three meters to a line drawn on the floor, turn around and sit back down in the same chair. The time is measured in seconds. The results can be interpreted the following way: * ≤ 10 seconds = normal, good general health * ≤ 20 seconds = good mobility, can go out alone, mobile without a gait aid * \> 30 seconds = difficulties, cannot go outside alone, requires a gait aid |
| Walking speed | Baseline | Habitual (preferred) walking speed to cover 200m. Normal values for older men: 1.21m/s -1.32m/s), older women 1.07m/s -1.19m/s). |
| Average time held on a leg obtained accordion to the Unipedal stance test | Week 7 (follow-up) | The Unipedal stance test measure the ability to stand on one leg and maintain balance. The participants are asked to stand as long as possible on one leg. The exercise is repeated three times for each leg. The time is measure in seconds. The average of the scores is calculated. The mean time held for people aged 70-79 is 14.2 +/- 9.3 seconds. |
| Score at the Geriatric Depression Scale (GDS) | Baseline | The Geriatric Depression Scale (GDS) is a self-rating scale designed for rating depression in older adults. The GDS questionnaire is composed of 15 questions. 10 of the questions indicate the presence of depression when answered positively, the 5 others indicate the presence of depression if answered negatively. * A score between 0 and 5 indicate a normal state. * A score between 5 and 11 indicate a mild to moderate depression. * A score between 11 and 15 indicate a severe depression. |
| Score at the Falls Efficacy Scale International (FES-I) | Baseline | The FES-I questionnaire measure the concern about falling. The questionnaire is composed of 16 questions with 4 choices valued from 1 to 4: not at all concerned (1), a little concerned (2), somewhat concerned (3), and very concerned (4). The minimum score is 16 and the highest 64. * A score between 16 and 19 indicate a low concern about falling. * A score between 20 and 27 indicates a moderate concern about falling. * A score above 28 indicates a high concern about falling. |
| Level of physical activity over the last seven days | Baseline | The Questionnaire d'activité physique pour les personnes âgées (QAPPA) evaluates the level of physical activity (LoPA) over the last 7days. Moderate (M) and Vigorous (V) physical activity (PA) are distinguished. The time spent per week (minutes) is multiplied by 8 for V activities and by 4 for the M activities and indicate the level of MET-min/week (Metabolic Equivalent of Task). Moderate LoPA: 1. 150 minutes of PA (M, V or both) spread over at least 3 days of the last 7 days. 2. 800 MET-min/week of PA (M, V, or both) spread over 2 days of the last 7 days. 3. At least 20 minutes of V PA spread over 3 days of the last 7 days. High LoPA: 1. At least 1500 MET-min/week of V PA spread over 3 days of the last 7 days 2. At least 3000 MET-min/week of M, V, or both, PA spread over 3 days of the last 7 days. Low LoPA: cases that do not meet the classification for moderate or high level of activity. |
| Measure of the quality of life and well-being | Baseline | The Investigating Choice Experiments for the Preferences of Older People (ICEPOP) CAPability (ICECAP-O) is a capability-based measure of the general quality of life of older people (≥ 65 years old). The ICECAP-O measures 5 attributes,each attribute has 4 level of answers. The 20 ICECAP-O attribute levels are estimated independently of one another such as the lowest level of capability (no capability on all attributes) was given a total value of 0 and the highest level of capability (full capability on all attributes) was given a total value of 1. The ICEPCAP-O range on a scale from 0 to 1. |
| Number of falls over the past year | Baseline | The number of falls over the past year will be use to determine the retrospective fall rate. |
| Number of falls over three months | Between 0 and 3 months after the end of the training program (week 4). | The number of falls over three month will be used to determine the prospective fall rate. The measure will be taken every three month until 18 moths after the beginning of the training program or in the case the participants felt two times between the measure and the end of the training program. |
| Number of falls over three month | Between 3 and 6 months after the end of the training program (week 4). | The number of falls over three month will be used to determine the prospective fall rate. The measure will be taken every three month until 18 moths after the beginning of the training program or in the case the participants felt two times between the measure and the end of the training program. |
| Perception of the training program | Week 4 | Narrative feedback after transcription of semi-structured interviews. Quotes will be chosen to demonstrate themes which were common, or which represented a summary of a topic. |
| Number of participants withdrawing from the study | Week 7 (follow-up) | The number of participants withdrawing from the study will be used to measure the adherence to the training program. |
| Average time held on a leg obtained following the Unipedal stance test | Baseline | The Unipedal stance test measure the ability to stand on one leg and maintain balance. The participants are asked to stand as long as possible on one leg. The exercise is repeated three times for each leg. The time is measure in seconds. The average of the scores is calculated. The mean time held for people aged 70-79 is 14.2 +/- 9.3 seconds. |
Countries
Switzerland
Contacts
Primary ContactPhilippe Terrier, PhD
Backup ContactJeremy Torrent, MSc
Outcome results
None listed