Arm-in-Arm Gait Training Trial (AAGaTT)

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Aging
• Intervention / Treatment: Other: Normal gait training; Other: Arm-in-arm gait training

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 Type: Interventional
• Enrollment (Estimated): 132
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Philippe Terrier, PhD; Phone Number: +41 32 930 12 55; Email: philippe.terrier@he-arc.ch
• Study Contact Backup: Name: Jeremy Torrent, MSc; Phone Number: +41 32 930 12 73; Email: jeremy.torrent@he-arc.ch

Study Locations

• Switzerland
  • Neuchâtel, Switzerland, 2000
    • Recruiting
    • Haute-Ecole Arc Santé
    • Contact: Philippe Terrier, PhD; Phone Number: +41 32 930 12 55; Email: aagatt@he-arc.ch
    • Contact: Jeremy Torrent, MSc; Phone Number: +41 32 930 12 73; Email: aagatt@he-arc.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Normal gait training; 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.	Other: Normal gait training; An older adult walk side-by-side, without contact, with a younger adult without step synchronization.
Experimental: Arm-in-arm gait training; 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.	Other: Arm-in-arm gait training; An older adult walk side-by-side, arm-in-arm with a younger adult while synchronizing steps.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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).	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).	Week 7 (follow-up)
Average step frequency	Average number of steps per second while walking at habitual (preferred) speed over 200m.	Baseline
Step frequency	Average number of steps per second while walking at habitual (preferred) speed over 200m.	Week 1
Step frequency	Average number of steps per second while walking at habitual (preferred) speed over 200m.	Week 2
Step frequency	Average number of steps per second while walking at habitual (preferred) speed over 200m.	Week 3
Step frequency	Average number of steps per second while walking at habitual (preferred) speed over 200m.	Week 4
Step frequency	Average number of steps per second while walking at habitual (preferred) speed over 200m.	Week 7 (follow-up)
Step length	Average step length while walking at habitual (preferred) speed over 200m.	Baseline
Step length	Average step length while walking at habitual (preferred) speed over 200m.	Week 1
Step length	Average step length while walking at habitual (preferred) speed over 200m.	Week 2
Step length	Average step length while walking at habitual (preferred) speed over 200m.	Week 3
Step length	Average step length while walking at habitual (preferred) speed over 200m.	Week 4
Step length	Average step length while walking at habitual (preferred) speed over 200m.	Week 7 (follow-up)
Step symmetry	Left / right symmetry of the gait assessed via the autocorrelation method. A high value shows a symmetric gait.	Baseline
Step symmetry	Left / right symmetry of the gait assessed via the autocorrelation method. A high value shows a symmetric gait.	Week 1
Step symmetry	Left / right symmetry of the gait assessed via the autocorrelation method. A high value shows a symmetric gait.	Week 2
Step symmetry	Left / right symmetry of the gait assessed via the autocorrelation method. A high value shows a symmetric gait.	Week 3
Step symmetry	Left / right symmetry of the gait assessed via the autocorrelation method. A high value shows a symmetric gait.	Week 4
Step symmetry	Left / right symmetry of the gait assessed via the autocorrelation method. A high value shows a symmetric gait.	Week 7 (follow-up)
Stride regularity	Left / right symmetry of the gait assessed via the autocorrelation method. A high value shows a symmetric gait.	Baseline
Stride regularity	Left / right symmetry of the gait assessed via the autocorrelation method. A high value shows a symmetric gait.	Week 1
Stride regularity	Regularity of the gait assessed via the autocorrelation method. A high value shows a less variable gait.	Week 2
Stride regularity	Regularity of the gait assessed via the autocorrelation method. A high value shows a less variable gait.	Week 3
Stride regularity	Regularity of the gait assessed via the autocorrelation method. A high value shows a less variable gait.	Week 4
Stride regularity	Regularity of the gait assessed via the autocorrelation method. A high value shows a less variable gait.	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.	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.	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.	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.	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.	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.	Week 7 (follow-up)
Gait attentional demand	Attractor complexity index. A high value indicates that less attention is dedicated to control gait (automated gait).	Baseline
Gait attentional demand	Attractor complexity index. A high value indicates that less attention is dedicated to control gait (automated gait).	Week 1
Gait attentional demand	Attractor complexity index. A high value indicates that less attention is dedicated to control gait (automated gait).	Week 2
Gait attentional demand	Attractor complexity index. A high value indicates that less attention is dedicated to control gait (automated gait).	Week 3
Gait attentional demand	Attractor complexity index. A high value indicates that less attention is dedicated to control gait (automated gait).	Week 4
Gait attentional demand	Attractor complexity index. A high value indicates that less attention is dedicated to control gait (automated gait).	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).	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).	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).	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).	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).	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).	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.	Baseline
Stride time variability	Variability of stride (gait cycle) duration over 200m walking. A high value shows a high stride-to-stride variability.	Week 1
Stride time variability	Variability of stride (gait cycle) duration over 200m walking. A high value shows a high stride-to-stride variability.	Week 2
Stride time variability	Variability of stride (gait cycle) duration over 200m walking. A high value shows a high stride-to-stride variability.	Week 3
Stride time variability	Variability of stride (gait cycle) duration over 200m walking. A high value shows a high stride-to-stride variability.	Week 4
Stride time variability	Variability of stride (gait cycle) duration over 200m walking. A high value shows a high stride-to-stride variability.	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	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	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	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	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	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	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Week 7 (follow-up)

Collaborators and Investigators

• Sponsor: Philippe Terrier
• Collaborators: Swiss National Science Foundation
• Investigators: Principal Investigator: Philippe Terrier, PhD, Haute-Ecole Arc

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2022
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 16, 2022
• First Submitted That Met QC Criteria: November 16, 2022
• First Posted (Actual): November 25, 2022

Study Record Updates

• Last Update Posted (Actual): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: physical activity; gait disorder; fall risk; complexity matching
• Other Study ID Numbers: 2022-01452

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: Study protocol will be published within 6 months after first recruitment. Anonymized dataset and acceleration data will be uploaded in parallel of result publications, within one year after the end of the study
• IPD Sharing Access Criteria: Study shared data will be publicly available on an open-access website following the FAIR (Findability, Accessibility, Interoperability, and Reuse) principles (zenodo.org).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No