Healthy AgingAAGaTTNCT05627453
Arm-in-Arm Gait Training Trial
A study testing Arm-in-arm gait training and Normal gait training in people with Healthy Aging, run by Philippe Terrier at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging
- What is being tested?
- Arm-in-arm gait training and Normal gait training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Jan 2022to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- Younger Participant
- Older than 18 years old but younger than 40 years old.
- No severe gait disorders from musculoskeletal or neurologic origin.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Haute-Ecole Arc Santé
Neuchâtel, 2000
Jeremy Torrent, MSc, +41 32 930 12 73, aagatt@he-arc.ch
Philippe Terrier, PhD, +41 32 930 12 55, aagatt@he-arc.ch
About this study
Official title: Helping Older People Recover Walking Abilities Through Arm-in-armg Gait Training: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Healthy Aging
- Being tested
- Arm-in-arm gait training, Normal gait training
- Keywords
- fall risk, gait disorder, physical activity, complexity matching
- Medical subject headings
- Mobility Limitation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm-in-arm gait trainingOther
An older adult walk side-by-side, arm-in-arm with a younger adult while synchronizing steps.
Normal gait trainingOther
An older adult walk side-by-side, without contact, with a younger adult without step synchronization.
| Study group | Role | What they receive |
|---|---|---|
| Normal gait training | Active comparator | 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. Receives: Other: Normal gait training |
| Arm-in-arm gait training | Experimental | 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. Receives: Other: Arm-in-arm gait training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking speed
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).
Measured: Week 4
Secondary outcomes (85)
Walking speed
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).
Measured: Baseline
Walking speed
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).
Measured: Week 1
Walking speed
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).
Measured: Week 2
Walking speed
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).
Measured: Week 3
Walking speed
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).
Measured: Week 7 (follow-up)
Average step frequency
Average number of steps per second while walking at habitual (preferred) speed over 200m.
Measured: Baseline
Step frequency
Average number of steps per second while walking at habitual (preferred) speed over 200m.
Measured: Week 1
Step frequency
Average number of steps per second while walking at habitual (preferred) speed over 200m.
Measured: Week 2
Step frequency
Average number of steps per second while walking at habitual (preferred) speed over 200m.
Measured: Week 3
Step frequency
Average number of steps per second while walking at habitual (preferred) speed over 200m.
Measured: Week 4
Step frequency
Average number of steps per second while walking at habitual (preferred) speed over 200m.
Measured: Week 7 (follow-up)
Step length
Average step length while walking at habitual (preferred) speed over 200m.
Measured: Baseline
Step length
Average step length while walking at habitual (preferred) speed over 200m.
Measured: Week 1
Step length
Average step length while walking at habitual (preferred) speed over 200m.
Measured: Week 2
Step length
Average step length while walking at habitual (preferred) speed over 200m.
Measured: Week 3
Step length
Average step length while walking at habitual (preferred) speed over 200m.
Measured: Week 4
Step length
Average step length while walking at habitual (preferred) speed over 200m.
Measured: Week 7 (follow-up)
Step symmetry
Left / right symmetry of the gait assessed via the autocorrelation method. A high value shows a symmetric gait.
Measured: Baseline
Step symmetry
Left / right symmetry of the gait assessed via the autocorrelation method. A high value shows a symmetric gait.
Measured: Week 1
Step symmetry
Left / right symmetry of the gait assessed via the autocorrelation method. A high value shows a symmetric gait.
Measured: Week 2
Step symmetry
Left / right symmetry of the gait assessed via the autocorrelation method. A high value shows a symmetric gait.
Measured: Week 3
Step symmetry
Left / right symmetry of the gait assessed via the autocorrelation method. A high value shows a symmetric gait.
Measured: Week 4
Step symmetry
Left / right symmetry of the gait assessed via the autocorrelation method. A high value shows a symmetric gait.
Measured: Week 7 (follow-up)
Stride regularity
Left / right symmetry of the gait assessed via the autocorrelation method. A high value shows a symmetric gait.
Measured: Baseline
Stride regularity
Left / right symmetry of the gait assessed via the autocorrelation method. A high value shows a symmetric gait.
Measured: Week 1
Stride regularity
Regularity of the gait assessed via the autocorrelation method. A high value shows a less variable gait.
Measured: Week 2
Stride regularity
Regularity of the gait assessed via the autocorrelation method. A high value shows a less variable gait.
Measured: Week 3
Stride regularity
Regularity of the gait assessed via the autocorrelation method. A high value shows a less variable gait.
Measured: Week 4
Stride regularity
Regularity of the gait assessed via the autocorrelation method. A high value shows a less variable gait.
Measured: Week 7 (follow-up)
Gait Stability
short-term Local dynamic stability (maximal Lyapunov exponent). A low value shows a more stable gait and a lower risk of fall.
Measured: Baseline
Gait Stability
short-term Local dynamic stability (maximal Lyapunov exponent). A low value shows a more stable gait and a lower risk of fall.
Measured: Week 1
Gait Stability
short-term Local dynamic stability (maximal Lyapunov exponent). A low value shows a more stable gait and a lower risk of fall.
Measured: Week 2
Gait Stability
short-term Local dynamic stability (maximal Lyapunov exponent). A low value shows a more stable gait and a lower risk of fall.
Measured: Week 3
Gait Stability
short-term Local dynamic stability (maximal Lyapunov exponent). A low value shows a more stable gait and a lower risk of fall.
Measured: Week 4
Gait Stability
short-term Local dynamic stability (maximal Lyapunov exponent). A low value shows a more stable gait and a lower risk of fall.
Measured: Week 7 (follow-up)
Gait attentional demand
Attractor complexity index. A high value indicates that less attention is dedicated to control gait (automated gait).
Measured: Baseline
Gait attentional demand
Attractor complexity index. A high value indicates that less attention is dedicated to control gait (automated gait).
Measured: Week 1
Gait attentional demand
Attractor complexity index. A high value indicates that less attention is dedicated to control gait (automated gait).
Measured: Week 2
Gait attentional demand
Attractor complexity index. A high value indicates that less attention is dedicated to control gait (automated gait).
Measured: Week 3
Gait attentional demand
Attractor complexity index. A high value indicates that less attention is dedicated to control gait (automated gait).
Measured: Week 4
Gait attentional demand
Attractor complexity index. A high value indicates that less attention is dedicated to control gait (automated gait).
Measured: Week 7 (follow-up)
Fractal index
Attentional demand measured via detrended fluctuation analysis (DFA). A high value indicates that less attention is dedicated to control gait (automated gait).
Measured: Baseline
Fractal index
Attentional demand measured via detrended fluctuation analysis (DFA). A high value indicates that less attention is dedicated to control gait (automated gait).
Measured: Week 1
Fractal index
Attentional demand measured via detrended fluctuation analysis (DFA).A high value indicates that less attention is dedicated to control gait (automated gait).
Measured: Week 2
Fractal index
Attentional demand measured via detrended fluctuation analysis (DFA).A high value indicates that less attention is dedicated to control gait (automated gait).
Measured: Week 3
Fractal index
Attentional demand measured via detrended fluctuation analysis (DFA).A high value indicates that less attention is dedicated to control gait (automated gait).
Measured: Week 4
Fractal index
Attentional demand measured via detrended fluctuation analysis (DFA).A high value indicates that less attention is dedicated to control gait (automated gait).
Measured: Week 7 (follow-up)
Stride time variability
Variability of stride (gait cycle) duration over 200m walking. A high value shows a high stride-to-stride variability.
Measured: Baseline
Stride time variability
Variability of stride (gait cycle) duration over 200m walking. A high value shows a high stride-to-stride variability.
Measured: Week 1
Stride time variability
Variability of stride (gait cycle) duration over 200m walking. A high value shows a high stride-to-stride variability.
Measured: Week 2
Stride time variability
Variability of stride (gait cycle) duration over 200m walking. A high value shows a high stride-to-stride variability.
Measured: Week 3
Stride time variability
Variability of stride (gait cycle) duration over 200m walking. A high value shows a high stride-to-stride variability.
Measured: Week 4
Stride time variability
Variability of stride (gait cycle) duration over 200m walking. A high value shows a high stride-to-stride variability.
Measured: Week 7 (follow-up)
Time to perform Timed up-and-go (TUG) test.
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
Measured: Baseline
Time to perform Timed up-and-go (TUG) test.
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
Measured: Week 1
Time to perform Timed up-and-go (TUG) test.
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
Measured: Week 2
Time to perform Timed up-and-go (TUG) test.
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
Measured: Week 3
Time to perform the Timed up-and-go (TUG) test.
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
Measured: Week 4
Time to perform the Timed up-and-go (TUG) test.
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
Measured: Week 7 (follow-up)
Average time held on a leg obtained following the Unipedal stance test
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.
Measured: Baseline
Average time held on a leg obtained following the Unipedal stance test
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.
Measured: Week 1
Average time held on a leg obtained following the Unipedal stance test
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.
Measured: Week 2
Average time held on a leg obtained following the Unipedal stance test
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.
Measured: Week 3
Average time held on a leg obtained following the Unipedal stance test
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.
Measured: Week 4
Average time held on a leg obtained accordion to the Unipedal stance test
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.
Measured: Week 7 (follow-up)
Score at the Geriatric Depression Scale (GDS)
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.
Measured: Baseline
Score at the Geriatric Depression Scale (GDS)
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.
Measured: Week 4
Score at the Geriatric Depression Scale (GDS)
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.
Measured: Week 7 (follow-up)
Score at the Falls Efficacy Scale International (FES-I)
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.
Measured: Baseline
Score at the Falls Efficacy Scale International (FES-I)
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.
Measured: Week 4
Score at the Falls Efficacy Scale International (FES-I)
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.
Measured: Week 7 (follow-up)
Level of physical activity over the last seven days
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:
- 150 minutes of PA (M, V or both) spread over at least 3 days of the last 7 days.
- 800 MET-min/week of PA (M, V, or both) spread over 2 days of the last 7 days.
- At least 20 minutes of V PA spread over 3 days of the last 7 days.
High LoPA:
- At least 1500 MET-min/week of V PA spread over 3 days of the last 7 days
- 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.
Measured: Baseline
Level of physical activity over the last seven days
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:
- 150 minutes of PA (M, V or both) spread over at least 3 days of the last 7 days.
- 800 MET-min/week of PA (M, V, or both) spread over 2 days of the last 7 days.
- At least 20 minutes of V PA spread over 3 days of the last 7 days.
High LoPA:
- At least 1500 MET-min/week of V PA spread over 3 days of the last 7 days
- 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.
Measured: Week 4
Level of physical activity over the last seven days
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:
- 150 minutes of PA (M, V or both) spread over at least 3 days of the last 7 days.
- 800 MET-min/week of PA (M, V, or both) spread over 2 days of the last 7 days.
- At least 20 minutes of V PA spread over 3 days of the last 7 days.
High LoPA:
- At least 1500 MET-min/week of V PA spread over 3 days of the last 7 days
- 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.
Measured: Week 7 (follow-up)
Measure of the quality of life and well-being
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.
Measured: Baseline
Measure of the quality of life and well-being
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.
Measured: Week 4
Number of falls over the past year
The number of falls over the past year will be use to determine the retrospective fall rate.
Measured: Baseline
Number of falls over three months
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.
Measured: Between 0 and 3 months after the end of the training program (week 4).
Number of falls over three month
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.
Measured: Between 3 and 6 months after the end of the training program (week 4).
Number of falls over three months
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.
Measured: Between 6 and 9 months after the end of the training program (week 4).
Number of falls over three months
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.
Measured: Between 9 and 12 months after the end of the training program (week 4).
Number of falls over three months
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.
Measured: Between 12 and 15 months after the end of the training program (week 4).
Number of falls over three months
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.
Measured: Between 12 and 18 months after the end of the training program (week 4).
Perception of the training program
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.
Measured: Week 4
Number of participants withdrawing from the study
The number of participants withdrawing from the study will be used to measure the adherence to the training program.
Measured: Week 7 (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2022
- Study start20 Jan 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philippe Terrier
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation
- Responsible party
- Sponsor-investigator, Philippe Terrier, Haute Ecole ARC Sante
- Investigators
- Philippe Terrier, PhD, Principal investigator, Haute-Ecole Arc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05627453
- Sponsor's protocol ID
- 2022-01452
- Acronym
- AAGaTT
- Status last verified
- Feb 2024
- First submitted
- 16 Nov 2022
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: At the end of the study, the final dataset will be anonymized. The anonymization process will constitute in the replacement of the participant unique ID (identification) by a random number. The acceleration data will be publicly shared on an online digital data repository (Zenodo: https://zenodo.org/). The shared data will not contain identification information; that is, shared personal data will be restricted to sex, body mass, body height, and age at time of the experiment (rounded year). Only the overall scores of questionnaires will be shared. Regarding the results of the qualitative study, only the anonymized transcripts will be shared. The audio files will be erased after the end of the study. The study protocol will be published in an open-access journal.
Publications
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.
PubMed 30271666Van 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.
PubMed 26126532Sherrington 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.
PubMed 30703272Almurad 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.
PubMed 30564149Terrier 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.
PubMed 28368823Terrier 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.
PubMed 30212783Bohannon 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.
PubMed 21820535Gigonzac 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.
PubMed 37674129
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helping Older People Recover Walking Abilities Through Arm-in-armg Gait Training: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05627453
- Acronym / sponsor ID
- AAGaTT / 2022-01452
- Conditions
- Healthy Aging
- Keywords
- fall risk, gait disorder, physical activity, complexity matching
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Philippe TerrierUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 25 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Normal gait training | Active comparator | Other: Normal gait trainingThe 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. |
| Arm-in-arm gait training | Experimental | Other: Arm-in-arm gait trainingThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Older Participant
- Younger Participant
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm-in-arm gait trainingAn older adult walk side-by-side, arm-in-arm with a younger adult while synchronizing steps. | Other | Arm-in-arm gait training |
| Normal gait trainingAn older adult walk side-by-side, without contact, with a younger adult without step synchronization. | Other | Normal gait training |
Primary outcome
Walking speed
Time frame: 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).
85 secondary outcomes
Walking speed
Time frame: Baseline
Walking speed
Time frame: Week 1
Walking speed
Time frame: Week 2
Walking speed
Time frame: Week 3
Walking speed
Time frame: Week 7 (follow-up)
Average step frequency
Time frame: Baseline
Step frequency
Time frame: Week 1
Step frequency
Time frame: Week 2
Step frequency
Time frame: Week 3
Step frequency
Time frame: Week 4
Step frequency
Time frame: Week 7 (follow-up)
Step length
Time frame: Baseline
Step length
Time frame: Week 1
Step length
Time frame: Week 2
Step length
Time frame: Week 3
Step length
Time frame: Week 4
Step length
Time frame: Week 7 (follow-up)
Step symmetry
Time frame: Baseline
Step symmetry
Time frame: Week 1
Step symmetry
Time frame: Week 2
Step symmetry
Time frame: Week 3
Step symmetry
Time frame: Week 4
Step symmetry
Time frame: Week 7 (follow-up)
Stride regularity
Time frame: Baseline
Stride regularity
Time frame: Week 1
Stride regularity
Time frame: Week 2
Stride regularity
Time frame: Week 3
Stride regularity
Time frame: Week 4
Stride regularity
Time frame: Week 7 (follow-up)
Gait Stability
Time frame: Baseline
Gait Stability
Time frame: Week 1
Gait Stability
Time frame: Week 2
Gait Stability
Time frame: Week 3
Gait Stability
Time frame: Week 4
Gait Stability
Time frame: Week 7 (follow-up)
Gait attentional demand
Time frame: Baseline
Gait attentional demand
Time frame: Week 1
Gait attentional demand
Time frame: Week 2
Gait attentional demand
Time frame: Week 3
Gait attentional demand
Time frame: Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Background: PubMed 30271666Ghai 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.
- Background: PubMed 26126532Van 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.
- Background: PubMed 30703272Sherrington 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.
- Background: PubMed 30564149Almurad 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.
- Background: PubMed 28368823Terrier 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.
- Background: PubMed 30212783Terrier 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.
- Background: PubMed 21820535Bohannon 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.
- Derived from this study: PubMed 37674129Gigonzac 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.
- Individual participant dataSharing planned: Yes. At the end of the study, the final dataset will be anonymized. The anonymization process will constitute in the replacement of the participant unique ID (identification) by a random number. The acceleration data will be publicly shared on an online digital data repository (Zenodo: https://zenodo.org/). The shared data will not contain identification information; that is, shared personal data will be restricted to sex, body mass, body height, and age at time of the experiment (rounded year). Only the overall scores of questionnaires will be shared. Regarding the results of the qualitative study, only the anonymized transcripts will be shared. The audio files will be erased after the end of the study. The study protocol will be published in an open-access journal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Philippe Terrier, PhD principal investigator
Haute-Ecole Arc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm-in-arm gait training and Normal gait training in people with Healthy Aging, run by Philippe Terrier at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philippe Terrier, PhD (+41 32 930 12 55, philippe.terrier@he-arc.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking speed (time frame: Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05627453, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.