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The investigators will assess feasibility and acceptability of the Tele-Tai Chi (TC) intervention; explore changes in clinically relevant outcome measures including: physical activity, self-efficacy, quality of life, cognitive function, balance, gait, and evaluate changes in TC proficiency. To achieve this, the investigators are running a single-arm study for older adults that involves a 12-week home-based Tai Chi intervention. Study participation includes four remote and/or in-person (at Spaulding Rehabilitation Hospital) visits to evaluate study participants (mobility tests and questionnaires).
The overall goal of the study is to test the delivery of a novel Tele-Tai Chi (TC) intervention in a single-arm feasibility study for community-dwelling TC-naïve older adults. The investigators will assess feasibility and acceptability of the Tele-TC intervention and its specific components through both qualitative and quantitative feedback, as well as the systematic tracking of adherence data to inform future trials and potential clinical use of the Tele-TC system. The investigators will also explore changes in outcome measures including physical activity, self-efficacy, quality of life, cognition, balance and gait, and evaluate changes in TC proficiency.
Participants will be assessed at 4 timepoints over the course of the 12-week Tele-TC intervention: at baseline, at 4 weeks, at 8 weeks, and at 12 weeks.
Study participants will be instructed to train on their own at least three times a week and to participate in one-on-one live sessions with TC instructors two or more times during the study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tele-Tai Chi | Experimental | Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via a mobile application. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tele-Tai Chi | Device | Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via an application installed on a tablet. The intervention emphasizes essential TC movements that are easily comprehensible and can be performed repetitively in a flowing manner. The protocol includes up to six core TC movements based on the traditional Cheng Man-Ch'ing's Yang-style short form. Additionally, a set of traditional TC warm-up exercises that focus on loosening the physical body, incorporating mindfulness and imagery into movement, promoting overall relaxation, and coordinating breathing awareness are included. Chairs are used in the protocol for a subset of seated warm-up exercises, as well as for stability and rest as needed. Participants will be asked to practice the protocol (45-60 min) at home for at least 3 days a week for 12 weeks. The TC program will also include 2 or more live instructional sessions via Zoom with a TC instructor. |
| Measure | Description | Time Frame |
|---|---|---|
| Protocol Adherence | The percentage of Tele-Tai-Chi practice sessions completed by participants. | Percentage at post-intervention (after 12 weeks) |
| Retention of Study Participants | The percentage of participants who complete the study. | At study completion, 12 weeks from the beginning of the study |
| System Usability Scale | The scale is based on a 10-item questionnaire with five response options (from Strongly agree to Strongly disagree) in which participants rate the usability of the system. The scale ranges from 0 to 100, with higher scores indicating greater usability. | At post-intervention (after 12 weeks) |
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| Measure | Description | Time Frame |
|---|---|---|
| Ease of Use of the Tele-Tai Chi Platform (Qualitative Interview) | Qualitative interview about ease of use of the Tele-Tai Chi platform. | At post-intervention (after 12 weeks) |
| Activities-specific Balance Confidence (ABC) Scores |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paolo Bonato, PhD | Spaulding Rehabilitation Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaulding Rehabilitation Hospital | Boston | Massachusetts | 02129 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tele-Tai Chi | Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via a mobile application. Tele-Tai Chi: Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via an application installed on a tablet. The intervention emphasizes essential TC movements that are easily comprehensible and can be performed repetitively in a flowing manner. The protocol includes up to six core TC movements based on the traditional Cheng Man-Ch'ing's Yang-style short form. Additionally, a set of traditional TC warm-up exercises that focus on loosening the physical body, incorporating mindfulness and imagery into movement, promoting overall relaxation, and coordinating breathing awareness are included. Chairs are used in the protocol for a subset of seated warm-up exercises, as well as for stability and rest as needed. Participants will be asked to practice the protocol (45-60 min) at home for at least 3 days a week for 12 weeks. The TC program will also include 2 or more live instructional sessions via Zoom with a TC instructor. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tele-Tai Chi | Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via a mobile application. Tele-Tai Chi: Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via an application installed on a tablet. The intervention emphasizes essential TC movements that are easily comprehensible and can be performed repetitively in a flowing manner. The protocol includes up to six core TC movements based on the traditional Cheng Man-Ch'ing's Yang-style short form. Additionally, a set of traditional TC warm-up exercises that focus on loosening the physical body, incorporating mindfulness and imagery into movement, promoting overall relaxation, and coordinating breathing awareness are included. Chairs are used in the protocol for a subset of seated warm-up exercises, as well as for stability and rest as needed. Participants will be asked to practice the protocol (45-60 min) at home for at least 3 days a week for 12 weeks. The TC program will also include 2 or more live instructional sessions via Zoom with a TC instructor. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Protocol Adherence | The percentage of Tele-Tai-Chi practice sessions completed by participants. | Data analysis was limited only to subjects who participated in the intervention and completed both baseline and post-intervention assessments. | Posted | Mean | Standard Deviation | percentage of sessions completed | Percentage at post-intervention (after 12 weeks) |
|
Adverse events were collected throughout the intervention period (approx. 12 weeks).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tele-Tai Chi | Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via a mobile application. Tele-Tai Chi: Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via an application installed on a tablet. The intervention emphasizes essential TC movements that are easily comprehensible and can be performed repetitively in a flowing manner. The protocol includes up to six core TC movements based on the traditional Cheng Man-Ch'ing's Yang-style short form. Additionally, a set of traditional TC warm-up exercises that focus on loosening the physical body, incorporating mindfulness and imagery into movement, promoting overall relaxation, and coordinating breathing awareness are included. Chairs are used in the protocol for a subset of seated warm-up exercises, as well as for stability and rest as needed. Participants will be asked to practice the protocol (45-60 min) at home for at least 3 days a week for 12 weeks. The TC program will also include 2 or more live instructional sessions via Zoom with a TC instructor. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Delayed onset muscle pain | Musculoskeletal and connective tissue disorders | SNOMED CT | Non-systematic Assessment | Several subjects reported muscle soreness. Some attributed the muscle soreness to physical activity, including practicing Tai Chi. All instances resolved without intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paolo Bonato, PhD | Spaulding Rehabilitation Hospital | 617-952-6319 | pbonato@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 19, 2022 | Aug 2, 2024 | Prot_SAP_001.pdf |
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|
This is 16-item self-report measure in which participants rate their balance confidence to perform motor activities. The minimum score is 0. The maximum score is 100. Positive changes (i.e., higher scores post-intervention) would represent a positive outcome.
| Changes from baseline at 12 weeks (post-intervention) |
| Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Scores | The PROMIS 29 instrument is a 29-item questionnaire assessing each of the following domains: anxiety, depression, fatigue, physical function, pain interference, pain intensity, sleep disturbance, and ability to participate in social roles and activities. The minimum score is 4 per domain, except for pain intensity for which the minimum score is 0. The maximum score per domain is 20, except for pain intensity for which the maximum score is 10. For the physical function and the ability to participate in social roles and activities domains a high score is indicative of positive outcome. For the anxiety, depression, fatigue, sleep disturbance, pain interference, and pain intensity a low score is indicative of positive outcome. | Changes from baseline at 12 weeks (post-intervention) |
| Physical Activity Scale for the Elderly (PASE) | Self-reported level of physical activity in individuals aged 65 years or older during the previous 7 days. The score accounts for the type of activities performed and the time of performance of each activity. The minimum score is 0. The scale has theoretical maximum value of 864, if subjects spent 24 hours per day over 7 days engaged in vigorous activities. However, as this is not possible, a maximum value of 400 is typically considered as that would correspond to being engage in vigorous activities for 8 hours per day + more moderate activities for 4.5 hours per day. | Changes from baseline to post-intervention (at 12 weeks) |
| Trail Making Test A/B Scores | The test to assess executive cognitive function. It has two parts: TMT A (number sequence only) considers visual search, and TMT B (alternating numbers and letters) evaluates executive control. The participant is asked to draw a line between 24 circles randomly arranged on a page that have to be linked in consecutive order. The TMT is scored by how long it takes to complete the test. | Changes from baseline at 12 weeks (post-intervention) |
| Self-Efficacy Exercise (SEE) Questionnaire | 9-item questionnaire that focuses on the self-efficacy expectations for exercise for older adults. The minimum score is 0. The maximum score is 90. Positive changes (i.e., higher scores post-intervention) would represent a positive outcome. | Changes from baseline at 12 weeks (post-intervention) |
| Change in Tai Chi Proficiency Score | Tai Chi experts will use video recordings to score proficiency using a developed instrument to score each of the six Tai Chi movements performed by participants. The minimum score is 6. The maximum score is 30 per Tai Chi exercise. Positive changes (i.e., higher scores post-intervention) would represent a positive outcome. The change in Tai Chi proficiency score ranges from -24 to +24. A change equal to 0 represents no change in proficiency. | Changes from baseline at 12 weeks (post-intervention) |
| Timed-Up-and-Go | Test routinely used in clinical practice to determine fall risk. The participant is asked to stand up from a chair, walk 3 meters, turns 180°, walk 3 meters back, and sits back down with back resting against the chair. | Changes from baseline at 12 weeks (post-intervention) |
| Timed-Up-and-Go Dual Task | Test routinely used in clinical practice to determine fall risk and ambulation status. The participant is asked to stand up from a chair, walk 3 meters, turns 180°, walk 3 meters back, and sits back down with back resting against the chair while counting backwards by three. | Changes from baseline at 12 weeks (post-intervention) |
| Single Leg Stance | Measured with a motion capture system. Balance on each leg (two trials): The participant is asked to stand on one leg for as long as they can up to a maximum of 30 seconds. | Changes from baseline at 12 weeks (post-intervention) |
| Sit-to-Stand Performance | Measure of fall risks. The participant is asked to stand up from a chair while keeping their arms crossed across their chest and repeat the task as many times as possible during a period of 30 seconds. | Changes from baseline at 12 weeks (post-intervention) |
| Postural Sway and Balance | Participants are instructed to perform two tasks: 1) stand on both legs with feet shoulder-width apart for approximately 20 seconds, and 2) stand on both legs with feet close to each other again for approximately 20 seconds. A sensor positioned at the waist is used to track the displacement of the center of mass during the 20 second data collection (for each task). The root mean square (RMS) value of the acceleration data collected using the sensor positioned at the waist is estimated in the antero-posterior (AP) and medio-lateral (ML) directions for the middle 15 seconds of each experiment. Data is gathered at baseline and post-intervention and derived for each condition for a total of 8 variables. | Baseline and post-intervention (approximately 12 weeks) |
| Normalized-to-height Stride Length | Study participants undergo an instrumented gait evaluation. Stride length is defined as the distance from ipsilateral foot contact to the next ipsilateral foot contact during gait. Normalized-to-height stride length is derived by computing the stride length and dividing such value by the height of the study participant. | Baseline and post-intervention (approximately 12 weeks) |
| Activity Level | Physical activity (e.g. number of steps per day) derived using a wrist-worn activity monitor. | Changes from baseline at 12 weeks (post-intervention) |
| Mini-Balance Evaluation Systems Test (MiniBEST) | MiniBEST Test: Test to assess dynamic balance. It is a 14-item test scored using a three-level ordinal scale. This test will be performed only in individuals who are willing to be tested in the laboratory (as opposed to via a remote visit). The minimum score is 0. The maximum score is 28. Positive changes (i.e., higher scores post-intervention) would represent a positive outcome. | Changes from baseline at 12 weeks (post-intervention) |
| Controlled Oral Word Association Test (COWAT) Scores | The test examines working memory span. COWAT requires the participant to produce as many words as possible that begin with a given letter of the alphabet (F,A,S). There is 1 minute allowed for each of the three letters. The score is the sum of all acceptable words produced in the three trials. | Changes from baseline at 12 weeks (post-intervention) |
| Change in Digit Span Test Score | The test assesses short-term memory by asking participants to memorize and recall in correct serial order a number of digits (i.e., numerals from 0 to 9). The test start asking participants to memorize fewer digits and then the number of digits is increased. The number sequences get progressively more difficult. Scores are based on the number of sequences correctly recalled (i.e., until the participant consecutively fails two trials of the same digit span length). | Changes from baseline at 12 weeks (post-intervention) |
| Change in Grip Strength | Investigators measure the grip strength of both upper limbs using a hand grip dynamometer. They repeat the measure three times (per side) for a total of six trials. The average value of the six trials is derived. Measures are gather at baseline and post-intervention. The difference in mean values (post-intervention minus baseline) is reported. | Changes from baseline at 12 weeks (post-intervention) |
| Stride Time Variability | Study participants undergo an instrumented gait evaluation. Stride time is measured as the time from foot contact to the next foot contact of the same leg. Stride time variability is defined as the standard deviation of the stride time values estimated for a session. | Baseline and post-intervention (approximately 12 weeks) |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Retention of Study Participants | The percentage of participants who complete the study. | Please note that 1 participant who was found not eligible after consent. | Posted | Number | percentage of subjects retained | At study completion, 12 weeks from the beginning of the study |
|
|
|
| Primary | System Usability Scale | The scale is based on a 10-item questionnaire with five response options (from Strongly agree to Strongly disagree) in which participants rate the usability of the system. The scale ranges from 0 to 100, with higher scores indicating greater usability. | Data analysis was limited only to subjects who participated in the intervention and completed both baseline and post-intervention assessments. | Posted | Mean | Standard Deviation | score on a scale | At post-intervention (after 12 weeks) |
|
|
|
| Other Pre-specified | Ease of Use of the Tele-Tai Chi Platform (Qualitative Interview) | Qualitative interview about ease of use of the Tele-Tai Chi platform. | 1 of the 8 participants was found ineligible after providing consent. 1 additional participant did not provide feedback about the ease of use of the Tai Chi platform. The remaining 6 subjects provided positive feedback. | Posted | Number | percentage of participants | At post-intervention (after 12 weeks) |
|
|
|
| Other Pre-specified | Activities-specific Balance Confidence (ABC) Scores | This is 16-item self-report measure in which participants rate their balance confidence to perform motor activities. The minimum score is 0. The maximum score is 100. Positive changes (i.e., higher scores post-intervention) would represent a positive outcome. | Data analysis was limited only to subjects who participated in the intervention and completed both baseline and post-intervention assessments. | Posted | Mean | Standard Deviation | score on a scale | Changes from baseline at 12 weeks (post-intervention) |
|
|
|
| Other Pre-specified | Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Scores | The PROMIS 29 instrument is a 29-item questionnaire assessing each of the following domains: anxiety, depression, fatigue, physical function, pain interference, pain intensity, sleep disturbance, and ability to participate in social roles and activities. The minimum score is 4 per domain, except for pain intensity for which the minimum score is 0. The maximum score per domain is 20, except for pain intensity for which the maximum score is 10. For the physical function and the ability to participate in social roles and activities domains a high score is indicative of positive outcome. For the anxiety, depression, fatigue, sleep disturbance, pain interference, and pain intensity a low score is indicative of positive outcome. | Data analysis was limited only to subjects who participated in the intervention and completed both baseline and post-intervention assessments. | Posted | Mean | Standard Deviation | score on a scale | Changes from baseline at 12 weeks (post-intervention) |
|
|
|
| Other Pre-specified | Physical Activity Scale for the Elderly (PASE) | Self-reported level of physical activity in individuals aged 65 years or older during the previous 7 days. The score accounts for the type of activities performed and the time of performance of each activity. The minimum score is 0. The scale has theoretical maximum value of 864, if subjects spent 24 hours per day over 7 days engaged in vigorous activities. However, as this is not possible, a maximum value of 400 is typically considered as that would correspond to being engage in vigorous activities for 8 hours per day + more moderate activities for 4.5 hours per day. | Data analysis was limited only to subjects who participated in the intervention and completed both baseline and post-intervention assessments. | Posted | Mean | Standard Deviation | score on a scale | Changes from baseline to post-intervention (at 12 weeks) |
|
|
|
| Other Pre-specified | Trail Making Test A/B Scores | The test to assess executive cognitive function. It has two parts: TMT A (number sequence only) considers visual search, and TMT B (alternating numbers and letters) evaluates executive control. The participant is asked to draw a line between 24 circles randomly arranged on a page that have to be linked in consecutive order. The TMT is scored by how long it takes to complete the test. | Data analysis was limited only to subjects who participated in the intervention and completed both baseline and post-intervention assessments. | Posted | Mean | Standard Deviation | seconds | Changes from baseline at 12 weeks (post-intervention) |
|
|
|
| Other Pre-specified | Self-Efficacy Exercise (SEE) Questionnaire | 9-item questionnaire that focuses on the self-efficacy expectations for exercise for older adults. The minimum score is 0. The maximum score is 90. Positive changes (i.e., higher scores post-intervention) would represent a positive outcome. | Data analysis was limited only to subjects who participated in the intervention and completed both baseline and post-intervention assessments. | Posted | Mean | Standard Deviation | score on a scale | Changes from baseline at 12 weeks (post-intervention) |
|
|
|
| Other Pre-specified | Change in Tai Chi Proficiency Score | Tai Chi experts will use video recordings to score proficiency using a developed instrument to score each of the six Tai Chi movements performed by participants. The minimum score is 6. The maximum score is 30 per Tai Chi exercise. Positive changes (i.e., higher scores post-intervention) would represent a positive outcome. The change in Tai Chi proficiency score ranges from -24 to +24. A change equal to 0 represents no change in proficiency. | 1 of the 8 participants was found ineligible after providing consent. 1 additional participant did not completed both baseline and post-intervention assessments. Data analysis was limited the remaining 6 participants completed both baseline and post-intervention assessments. | Posted | Mean | Standard Deviation | score on a scale | Changes from baseline at 12 weeks (post-intervention) |
|
|
|
| Other Pre-specified | Timed-Up-and-Go | Test routinely used in clinical practice to determine fall risk. The participant is asked to stand up from a chair, walk 3 meters, turns 180°, walk 3 meters back, and sits back down with back resting against the chair. | Data analysis was limited only to subjects who participated in the intervention and completed both baseline and post-intervention assessments. | Posted | Mean | Standard Deviation | seconds | Changes from baseline at 12 weeks (post-intervention) |
|
|
|
| Other Pre-specified | Timed-Up-and-Go Dual Task | Test routinely used in clinical practice to determine fall risk and ambulation status. The participant is asked to stand up from a chair, walk 3 meters, turns 180°, walk 3 meters back, and sits back down with back resting against the chair while counting backwards by three. | Data analysis was limited only to subjects who participated in the intervention and completed both baseline and post-intervention assessments. | Posted | Mean | Standard Deviation | seconds | Changes from baseline at 12 weeks (post-intervention) |
|
|
|
| Other Pre-specified | Single Leg Stance | Measured with a motion capture system. Balance on each leg (two trials): The participant is asked to stand on one leg for as long as they can up to a maximum of 30 seconds. | Data analysis was limited only to subjects who participated in the intervention and completed both baseline and post-intervention assessments. Only the trial with the longest time was considered for analysis. | Posted | Mean | Standard Deviation | seconds | Changes from baseline at 12 weeks (post-intervention) |
|
|
|
| Other Pre-specified | Sit-to-Stand Performance | Measure of fall risks. The participant is asked to stand up from a chair while keeping their arms crossed across their chest and repeat the task as many times as possible during a period of 30 seconds. | Data analysis was limited only to subjects who participated in the intervention and completed both baseline and post-intervention assessments. | Posted | Mean | Standard Deviation | repetitions | Changes from baseline at 12 weeks (post-intervention) |
|
|
|
| Other Pre-specified | Postural Sway and Balance | Participants are instructed to perform two tasks: 1) stand on both legs with feet shoulder-width apart for approximately 20 seconds, and 2) stand on both legs with feet close to each other again for approximately 20 seconds. A sensor positioned at the waist is used to track the displacement of the center of mass during the 20 second data collection (for each task). The root mean square (RMS) value of the acceleration data collected using the sensor positioned at the waist is estimated in the antero-posterior (AP) and medio-lateral (ML) directions for the middle 15 seconds of each experiment. Data is gathered at baseline and post-intervention and derived for each condition for a total of 8 variables. | Data analysis was limited only to subjects who participated in the intervention and completed both baseline and post-intervention assessments. The root mean square (RMS) value of the acceleration in the antero-posterior (AP) and medio-lateral (ML) directions at the waist sensor was calculated for middle 15 seconds of each experiment (i.e., standing on both legs with feet shoulder-width apart and standing on both legs with feet close to each other). | Posted | Mean | Standard Deviation | millimeters per second squared | Baseline and post-intervention (approximately 12 weeks) |
|
|
|
| Other Pre-specified | Normalized-to-height Stride Length | Study participants undergo an instrumented gait evaluation. Stride length is defined as the distance from ipsilateral foot contact to the next ipsilateral foot contact during gait. Normalized-to-height stride length is derived by computing the stride length and dividing such value by the height of the study participant. | Data analysis was limited only to subjects who participated in the intervention and completed both baseline and post-intervention assessments. | Posted | Mean | Standard Deviation | unitless | Baseline and post-intervention (approximately 12 weeks) |
|
|
|
| Other Pre-specified | Activity Level | Physical activity (e.g. number of steps per day) derived using a wrist-worn activity monitor. | Data analysis was limited only to subjects who participated in the intervention and completed both baseline and post-intervention assessments. | Posted | Mean | Standard Deviation | steps per day | Changes from baseline at 12 weeks (post-intervention) |
|
|
|
| Other Pre-specified | Mini-Balance Evaluation Systems Test (MiniBEST) | MiniBEST Test: Test to assess dynamic balance. It is a 14-item test scored using a three-level ordinal scale. This test will be performed only in individuals who are willing to be tested in the laboratory (as opposed to via a remote visit). The minimum score is 0. The maximum score is 28. Positive changes (i.e., higher scores post-intervention) would represent a positive outcome. | Data analysis was limited only to subjects who participated in the intervention and completed both baseline and post-intervention assessments. | Posted | Mean | Standard Deviation | score on a scale | Changes from baseline at 12 weeks (post-intervention) |
|
|
|
| Other Pre-specified | Controlled Oral Word Association Test (COWAT) Scores | The test examines working memory span. COWAT requires the participant to produce as many words as possible that begin with a given letter of the alphabet (F,A,S). There is 1 minute allowed for each of the three letters. The score is the sum of all acceptable words produced in the three trials. | Data analysis was limited only to subjects who participated in the intervention and completed both baseline and post-intervention assessments. | Posted | Mean | Standard Deviation | words | Changes from baseline at 12 weeks (post-intervention) |
|
|
|
| Other Pre-specified | Change in Digit Span Test Score | The test assesses short-term memory by asking participants to memorize and recall in correct serial order a number of digits (i.e., numerals from 0 to 9). The test start asking participants to memorize fewer digits and then the number of digits is increased. The number sequences get progressively more difficult. Scores are based on the number of sequences correctly recalled (i.e., until the participant consecutively fails two trials of the same digit span length). | Data analysis was limited only to subjects who participated in the intervention and completed both baseline and post-intervention assessments. Only the length of the longest sequence successfully completed was considered. | Posted | Mean | Standard Deviation | sequences | Changes from baseline at 12 weeks (post-intervention) |
|
|
|
| Other Pre-specified | Change in Grip Strength | Investigators measure the grip strength of both upper limbs using a hand grip dynamometer. They repeat the measure three times (per side) for a total of six trials. The average value of the six trials is derived. Measures are gather at baseline and post-intervention. The difference in mean values (post-intervention minus baseline) is reported. | Data analysis was limited only to subjects who participated in the intervention and completed both baseline and post-intervention assessments. The average of three trials was considered for the analysis. | Posted | Mean | Standard Deviation | kilograms | Changes from baseline at 12 weeks (post-intervention) |
|
|
|
| Other Pre-specified | Stride Time Variability | Study participants undergo an instrumented gait evaluation. Stride time is measured as the time from foot contact to the next foot contact of the same leg. Stride time variability is defined as the standard deviation of the stride time values estimated for a session. | Data analysis was limited only to subjects who participated in the intervention and completed both baseline and post-intervention assessments. | Posted | Mean | Standard Deviation | milliseconds | Baseline and post-intervention (approximately 12 weeks) |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 5 |
| 7 |
|
| Flu-like illness | Infections and infestations | SNOMED CT | Non-systematic Assessment | Several subjects reported flu-like symptoms including sore throat and muscle soreness. All resolved without intervention. |
|
| Low back pain | Musculoskeletal and connective tissue disorders | SNOMED CT | Non-systematic Assessment | Several subjects reported flares of pre-existing low back pain. None attributed the flares to the practice of Tai Chi. One was found to have a small, non-displaced fracture of the spine not requiring intervention. All symptoms returned to baseline. |
|
| Cholecystitis | Gastrointestinal disorders | SNOMED CT | Non-systematic Assessment | One subject reported vague right-sided abdominal pain. Coincidentally, he was found to have an infection of the gallbladder during a hospitalization for flu-like symptoms. Was awaiting possible sugical resolution at study end. |
|
| Fall | Injury, poisoning and procedural complications | SNOMED CT | Non-systematic Assessment | Several subjects reported falls, none were during the practice of Tai Chi. Falls did not result in hospitalization. |
|
Not provided
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| Title | Measurements |
|---|---|
|
| Fatigue |
|
| Pain Interference |
|
| Physical Function |
|
| Sleep Disturbance |
|
| Pain Intensity |
|
| Title | Measurements |
|---|---|
|
| Feet Apart ML - Post-intervention |
|
| Feet Together AP - Baseline |
|
| Feet Together AP - Post-Intervention |
|
| Feet Together ML - Baseline |
|
| Feet Together ML - Post-intervention |
|