腹部ヘルニア修復後の成果を改善するための腹部コアリハビリテーションのパイロットトライアル (ABVENTURE-P)

アクティブコンパレータ：標準的な術後の指示

対照群の参加者には、術後の退院時に、術後の指示に従うように告げられます。

他の：術後の注意事項

この介入には、世界中で腹部ヘルニア修復を受ける患者に通常与えられる術後の標準治療の指示が含まれています。 これらには、激しい身体活動の制限や、6週間の重量制限を10ポンド以下にすることが含まれます。 手術後 4 ～ 6 週間はバインダーの使用も推奨されます。

実験的：監視付き理学療法

理学療法グループの参加者は、手術の2週間後から理学療法クリニックを訪れる予定で、標準化された科学的根拠に基づいた腹部コア手術後のリハビリテーションに従って、週に約2回、8週間にわたって監視付き理学療法治療を受けます。プログラム。

他の：監視付き理学療法

週に 2 回、8 週間にわたる監視付き理学療法コースは、手術の 2 週間後に始まります。 段階的な筋肉の再トレーニングと強化、および患者固有の姿勢と身体力学の教育を通じて、腹部のコア機能をターゲットとしています。

Change From Baseline in Five Times Sit-to-stand Time

From a standard chair, stand and sit back down five times in immediate succession as quickly as possible. The test is scored in seconds, where a shorter time represents greater mobility.

Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function

PROMIS-Physical Function is a computer-adaptive patient-reported questionnaire asking questions about physical function. The responses are converted to a t-score which is then reported as a percentile, where 50th percentile represents the average individual. Higher scores indicate greater physical function. This outcome is reported as a change in percentile, where a change of 0 indicates no change in physical function between the two timepoints and a positive change in percentile points indicates an improvement in physical function relative to the rest of the population.

Change From Baseline in Quiet Unstable Sitting Test

Sit on an inflated cushion that creates an unstable surface for 60 seconds with eyes closed and arms crossed while counting to a metronome. The raw measurement is the center of pressure excursion (cumulative amount of postural sway) of the participant during the 60 seconds. QUeST is scored as a scaled Z-score, where 0 represents the mean value for a healthy control population. A negative score indicates how many multiples of the standard error of measurement the participant is worse than the mean value for a healthy normal population. A positive change indicates improvement in core stability, with an MCID for change ≥1. The total range of the measure can be as high as 0 and has no explicit negative bound.

Change in Hernia Related Quality of Life Survey From Baseline

The Hernia-related Quality of Life Survey (HerQLeS) patient-reported questionnaire asks questions about how abdominal wall function affects activities of daily living, independent mobility, and mental health. The survey is scored on a 0-100 scale, where 100 indicates the highest quality of life and 0 indicates the worst.

Change in Timed Up-And-Go Time From Baseline

Starting seated in a standard chair, stand, walk forward 3 m, turn 180 deg, walk back to chair, sit down. Do all of these as quickly as can be done safely. The test is scored in seconds, and a lower time indicates better mobility.

Change From Baseline in International Physical Activity Questionnaire - Short Form

Self-reported physical activity questions spanning sedentary behavior, job activity, transportation activity, household activity, and recreational activity. The test is scored in Metabolic Equivalent of Task (MET)-minutes per week. More minutes means greater physical activity, either by increasing time or the intensity of the activity or both.

Change From Baseline in Tampa Scale of Kinesiophobia - Short Form

Self-reported 11-question survey on how fear affects desire and ability to perform physical activities. Scores range from 11 (lowest) to 44 (highest). Higher scores indicate greater fear, where 11-22 is minimal fear, 23-28 is low fear, 29-35 is moderate fear, and 36-44 is high fear.

Number of Participants With Hernia Recurrence Using the Hernia Recurrence Inventory

Patient-reported questionnaire asking questions regarding a recurrence of the hernia based on pain and presence of a physical bulge. A recurrence is determined by if the patient reports thinking the hernia has come back, feeling or seeing a bulge, or having pain or symptoms at the site. A positive response to any of these 3 questions is considered a recurrence. A recurrence is considered a suboptimal outcome.

Change in Hernia Related Quality of Life Survey From Baseline

The Hernia-related Quality of Life Survey (HerQLeS) patient-reported questionnaire asks questions about how abdominal wall function affects activities of daily living, independent mobility, and mental health. The survey is scored on a 0-100 scale, where 100 indicates the highest quality of life and 0 indicates the worst.

Change in Timed Up-And-Go Time From Baseline

Starting seated in a standard chair, stand, walk forward 3 m, turn 180 deg, walk back to chair, sit down. Do all of these as quickly as can be done safely. The test is scored in seconds, and a lower time indicates better mobility.

Change From Baseline in International Physical Activity Questionnaire - Long Form

Self-reported physical activity questions spanning sedentary behavior, job activity, transportation activity, household activity, and recreational activity. The test is scored in Metabolic Equivalent of Task (MET)-minutes per week. More minutes means greater physical activity, either by increasing time or the intensity of the activity or both.

Change From Baseline in Tampa Scale of Kinesiophobia - Short Form

Self-reported 11-question survey on how fear affects desire and ability to perform physical activities. Scores range from 11 (lowest) to 44 (highest). Higher scores indicate greater fear, where 11-22 is minimal fear, 23-28 is low fear, 29-35 is moderate fear, and 36-44 is high fear.

Change From Baseline in Five Times Sit-to-stand Time

From a standard chair, stand and sit back down five times in immediate succession as quickly as possible. The test is scored in seconds, where a shorter time represents greater mobility.

Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function

PROMIS-Physical Function is a computer-adaptive patient-reported questionnaire asking questions about physical function. The responses are converted to a t-score which is then reported as a percentile, where 50th percentile represents the average individual. Higher scores indicate greater physical function. This outcome is reported as a change in percentile, where a change of 0 indicates no change in physical function between the two timepoints and a positive change in percentile points indicates an improvement in physical function relative to the rest of the population.

Change From Baseline in Quiet Unstable Sitting Test

Sit on an inflated cushion that creates an unstable surface for 60 seconds with eyes closed and arms crossed while counting to a metronome. The raw measurement is the center of pressure excursion (cumulative amount of postural sway) of the participant during the 60 seconds. QUeST is scored as a scaled Z-score, where 0 represents the mean value for a healthy control population. A negative score indicates how many multiples of the standard error of measurement the participant is worse than the mean value for a healthy normal population. A positive change indicates improvement in core stability, with an MCID for change ≥1. The total range of the measure can be as high as 0 and has no explicit negative bound.

Change in Hernia Related Quality of Life Survey From Baseline

The Hernia-related Quality of Life Survey (HerQLeS) patient-reported questionnaire asks questions about how abdominal wall function affects activities of daily living, independent mobility, and mental health. The survey is scored on a 0-100 scale, where 100 indicates the highest quality of life and 0 indicates the worst.

Change in Timed Up-And-Go Time From Baseline

Starting seated in a standard chair, stand, walk forward 3 m, turn 180 deg, walk back to chair, sit down. Do all of these as quickly as can be done safely. The test is scored in seconds, and a lower time indicates better mobility.

Change From Baseline in International Physical Activity Questionnaire - Short Form

Self-reported physical activity questions spanning sedentary behavior, job activity, transportation activity, household activity, and recreational activity. The test is scored in Metabolic Equivalent of Task (MET)-minutes per week. More minutes means greater physical activity, either by increasing time or the intensity of the activity or both.

Change From Baseline in Tampa Scale of Kinesiophobia - Short Form

Self-reported 11-question survey on how fear affects desire and ability to perform physical activities. Scores range from 11 (lowest) to 44 (highest). Higher scores indicate greater fear, where 11-22 is minimal fear, 23-28 is low fear, 29-35 is moderate fear, and 36-44 is high fear.

Change From Baseline in Five Times Sit-to-stand Time

From a standard chair, stand and sit back down five times in immediate succession as quickly as possible. The test is scored in seconds, where a shorter time represents greater mobility.

Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function

PROMIS-Physical Function is a computer-adaptive patient-reported questionnaire asking questions about physical function. The responses are converted to a t-score which is then reported as a percentile, where 50th percentile represents the average individual. Higher scores indicate greater physical function. This outcome is reported as a change in percentile, where a change of 0 indicates no change in physical function between the two timepoints and a positive change in percentile points indicates an improvement in physical function relative to the rest of the population.

Change From Baseline in Quiet Unstable Sitting Test

Sit on an inflated cushion that creates an unstable surface for 60 seconds with eyes closed and arms crossed while counting to a metronome. The raw measurement is the center of pressure excursion (cumulative amount of postural sway) of the participant during the 60 seconds. QUeST is scored as a scaled Z-score, where 0 represents the mean value for a healthy control population. A negative score indicates how many multiples of the standard error of measurement the participant is worse than the mean value for a healthy normal population. A positive change indicates improvement in core stability, with an MCID for change ≥1. The total range of the measure can be as high as 0 and has no explicit negative bound.

Change in Hernia Related Quality of Life Survey From Baseline

The Hernia-related Quality of Life Survey (HerQLeS) patient-reported questionnaire asks questions about how abdominal wall function affects activities of daily living, independent mobility, and mental health. The survey is scored on a 0-100 scale, where 100 indicates the highest quality of life and 0 indicates the worst.

Change in Timed Up-And-Go Time From Baseline

Starting seated in a standard chair, stand, walk forward 3 m, turn 180 deg, walk back to chair, sit down. Do all of these as quickly as can be done safely. The test is scored in seconds, and a lower time indicates better mobility.

Change From Baseline in International Physical Activity Questionnaire - Long Form

Self-reported physical activity questions spanning sedentary behavior, job activity, transportation activity, household activity, and recreational activity. The test is scored in Metabolic Equivalent of Task (MET)-minutes per week. More minutes means greater physical activity, either by increasing time or the intensity of the activity or both.

Change From Baseline in Tampa Scale of Kinesiophobia - Short Form

The Hernia-related Quality of Life Survey (HerQLeS) patient-reported questionnaire asks questions about how abdominal wall function affects activities of daily living, independent mobility, and mental health. The survey is scored on a 0-100 scale, where 100 indicates the highest quality of life and 0 indicates the worst.

Change From Baseline in Five Times Sit-to-stand Time

From a standard chair, stand and sit back down five times in immediate succession as quickly as possible. The test is scored in seconds, where a shorter time represents greater mobility.

Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function

PROMIS-Physical Function is a computer-adaptive patient-reported questionnaire asking questions about physical function. The responses are converted to a t-score which is then reported as a percentile, where 50th percentile represents the average individual. Higher scores indicate greater physical function. This outcome is reported as a change in percentile, where a change of 0 indicates no change in physical function between the two timepoints and a positive change in percentile points indicates an improvement in physical function relative to the rest of the population.

Change From Baseline in Quiet Unstable Sitting Test

Sit on an inflated cushion that creates an unstable surface for 60 seconds with eyes closed and arms crossed while counting to a metronome. The raw measurement is the center of pressure excursion (cumulative amount of postural sway) of the participant during the 60 seconds. QUeST is scored as a scaled Z-score, where 0 represents the mean value for a healthy control population. A negative score indicates how many multiples of the standard error of measurement the participant is worse than the mean value for a healthy normal population. A positive change indicates improvement in core stability, with an MCID for change ≥1. The total range of the measure can be as high as 0 and has no explicit negative bound.