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| Name | Class |
|---|---|
| Stockholm South General Hospital | OTHER |
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The purpose of the study is to evaluate the feasibility of recruitment procedure, intervention including compliance and the collaboration between in- and out patient clinics of preoperative home-based exercise in older people before colorectal surgery.
The feasibility study will be conducted in order to evaluate the study design of a future RCT. Feasibility data will eg. consist of study flow description, number of eligible participants, included participants, patients and instructors satisfaction with the intervention, training compliance, reasons for drop-outs, and adverse events.
Patients waiting for colorectal surgery will be recruited and included after informed consent. Physical and respiratory function will be assessed at the hospital before the intervention, the day before surgery and the day before discharge. Data on postoperative complications, length of stay and mortality will be collected during the hospital stay. At baseline and six months after surgery, the participants will receive three questionnaires about level of independence in daily living, physical activity and health related quality of life. The intervention will be performed in the older person's home and consists of a combination of high-intensity respiratory training and individually adjusted functional exercise. Both groups will receive physical activity advice and malnutrition will be screened to optimize their nutritional status.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise group | Experimental | The sessions will be led by a physiotherapist, in the older person's home. The sessions will consist of inspiratory muscle training with a resistance starting from 50% of their maximal capacity (30 breathes, 2 times/day). The training session will also consist of high-intensity individually adjusted functional strength and endurance training: chair-stand; stair climb/step up with weight belts, interval walking indoor and/or outdoor. This will be combined with functional task-exercises. The training will be conducted 2-3 times week, for at least two weeks or until they undergo surgery. During the remaining days, the participants will be instructed to follow the recommendation of 30 minutes of moderate physical activity per day, as well as to perform inspiratory muscle training. |
|
| Control group | Other | The participants will receive ordinary preoperative information, but will also be encouraged to follow the recommendation of 150 minutes/week of moderate physical activity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Other | The sessions will be led by a physiotherapist, in the older person's home. The sessions will consist of inspiratory muscle training with a resistance starting from 50% of their maximal capacity (30 breathes, 2 times/day). The training session will also consist of high-intensity individually adjusted functional strength and endurance training: chair-stand; stair climb/step up with weight belts, interval walking indoor and/or outdoor. This will be combined with functional task-exercises. The training will be conducted 2-3 times week, for at least two weeks or until they undergo surgery. During the remaining days, the participants will be instructed to follow the recommendation of 30 minutes of moderate physical activity per day, as well as to perform inspiratory muscle training. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Rate | The recruitment rate is calculated by the number of participants allocated to either the exercise group or control group from the total number of eligible participants (n=66). | Baseline |
| Exercise Compliance | Compliance with the exercise intervention was defined as the number of sessions attended out of planned sessions and was registered in the exercise logs by the physiotherapists in primary care. Only participants randomized to the exercise group were evaluated for this assessment. | At the end of the intervention, after 2-4 weeks |
| Acceptability | Patients and instructors satisfaction with the intervention measured with a survey. Instructors were not enrolled. Only participants randomized to the exercise group were evaluated for this assessment. | At the end of the intervention, after 2-4 weeks |
| Adverse Events | Musculoskeletal-related events, cardiovascular episodes, falls and health care use that occurred during the exercise intervention before (pre)-surgery. Adverse events are only reported for the intervention group since the control group were a treatment as usual (TAU) group. | During the intervention, after 1-4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Six-minute Walk | Meters completed, effort estimated | Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery |
| Inspiratory Muscle Strength | Inspiratory muscle strength measured with MicroRPM. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elisabeth Rydwik, PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stockholm South General Hospital | Stockholm | 11883 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31265476 | Result | Karlsson E, Farahnak P, Franzen E, Nygren-Bonnier M, Dronkers J, van Meeteren N, Rydwik E. Feasibility of preoperative supervised home-based exercise in older adults undergoing colorectal cancer surgery - A randomized controlled design. PLoS One. 2019 Jul 2;14(7):e0219158. doi: 10.1371/journal.pone.0219158. eCollection 2019. |
| Label | URL |
|---|---|
| Feasibility of preoperative supervised homebased exercise in older adults undergoing colorectal cancer surgery - A randomized controlled design | View source |
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There were 66 eligible participants. Of those 66, 43 declined to participate due to: they did not want to delay surgery (n=6), felt it was too much stress (n=12), additional hospital visit (n=10), already exercising (n=3), no reason given (n=10), and could not be reached (n=2).
Patients scheduled for colorectal cancer surgery at Stockholm South General Hospital were informed about the study and asked to participate. The screening for inclusion was undertaken from September 2016 to June 2018 by a surgeon and nurse at the weekly colorectal cancer conferences (CRC).
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| ID | Title | Description |
|---|---|---|
| FG000 | Exercise Group | The sessions will be led by a physiotherapist, in the older person's home. The sessions will consist of inspiratory muscle training with a resistance starting from 50% of their maximal capacity (30 breathes, 2 times/day). The training session will also consist of high-intensity individually adjusted functional strength and endurance training: chair-stand; stair climb/step up with weight belts, interval walking indoor and/or outdoor. This will be combined with functional task-exercises. The training will be conducted 2-3 times week, for at least two weeks or until they undergo surgery. During the remaining days, the participants will be instructed to follow the recommendation of 30 minutes of moderate physical activity per day, as well as to perform inspiratory muscle training. |
| FG001 | Control Group | The participants will receive ordinary preoperative information, but will also be encouraged to follow the recommendation of 150 minutes/week of moderate physical activity. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
| |||||||||||||
| Follow-up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exercise Group | The sessions will be led by a physiotherapist, in the older person's home. The sessions will consist of inspiratory muscle training with a resistance starting from 50% of their maximal capacity (30 breathes, 2 times/day). The training session will also consist of high-intensity individually adjusted functional strength and endurance training: chair-stand; stair climb/step up with weight belts, interval walking indoor and/or outdoor. This will be combined with functional task-exercises. The training will be conducted 2-3 times week, for at least two weeks or until they undergo surgery. During the remaining days, the participants will be instructed to follow the recommendation of 30 minutes of moderate physical activity per day, as well as to perform inspiratory muscle training. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median |
| 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 | Recruitment Rate | The recruitment rate is calculated by the number of participants allocated to either the exercise group or control group from the total number of eligible participants (n=66). | The number of participants allocated to each group [exercise group (n=11), control group (n=12), overall study (n=23)] by the total number of eligible participants (n=66). | Posted | Count of Participants | Participants | Baseline |
|
|
Three 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 | Exercise Group | The sessions will be led by a physiotherapist, in the older person's home. The sessions will consist of inspiratory muscle training with a resistance starting from 50% of their maximal capacity (30 breathes, 2 times/day). The training session will also consist of high-intensity individually adjusted functional strength and endurance training: chair-stand; stair climb/step up with weight belts, interval walking indoor and/or outdoor. This will be combined with functional task-exercises. The training will be conducted 2-3 times week, for at least two weeks or until they undergo surgery. During the remaining days, the participants will be instructed to follow the recommendation of 30 minutes of moderate physical activity per day, as well as to perform inspiratory muscle training. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Elisabeth Rydwik | Karolinska Institutet | +46852488818 | elisabeth.rydwik@ki.se |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 26, 2016 | Sep 22, 2022 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
| Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery |
| Chair-stand 30-sec | Number of stands during 30 sec. | Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery |
| Walking Speed | Normal walking speed was measured over 10 meters. | Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery |
| Postoperative Complications | Clavien-Dindo, number of participants with at least one postoperative complication. | Within the first 30 days of surgery |
| Length of Stay | Number of days admitted to the hospital | At discharge, 2-4 weeks after baseline |
| NOT COMPLETED |
|
| BG001 | Control Group | The participants will receive ordinary preoperative information, but will also be encouraged to follow the recommendation of 150 minutes/week of moderate physical activity. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Type of surgery approach | Count of Participants | Participants |
|
|
|
| Primary | Exercise Compliance | Compliance with the exercise intervention was defined as the number of sessions attended out of planned sessions and was registered in the exercise logs by the physiotherapists in primary care. Only participants randomized to the exercise group were evaluated for this assessment. | The number of planned sessions and attended sessions. | Posted | Count of Units | Number of exercise sessions | At the end of the intervention, after 2-4 weeks | Number of exercise sessions | Number of exercise sessions |
|
|
|
| Primary | Acceptability | Patients and instructors satisfaction with the intervention measured with a survey. Instructors were not enrolled. Only participants randomized to the exercise group were evaluated for this assessment. | Posted | Count of Participants | Participants | At the end of the intervention, after 2-4 weeks |
|
|
|
| Primary | Adverse Events | Musculoskeletal-related events, cardiovascular episodes, falls and health care use that occurred during the exercise intervention before (pre)-surgery. Adverse events are only reported for the intervention group since the control group were a treatment as usual (TAU) group. | Posted | Count of Participants | Participants | During the intervention, after 1-4 weeks |
|
|
|
| Secondary | Six-minute Walk | Meters completed, effort estimated | Posted | Median | 95% Confidence Interval | meter | Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery |
|
|
|
| Secondary | Inspiratory Muscle Strength | Inspiratory muscle strength measured with MicroRPM. | Posted | Median | 95% Confidence Interval | cm H2O | Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery |
|
|
|
| Secondary | Chair-stand 30-sec | Number of stands during 30 sec. | Posted | Median | 95% Confidence Interval | Stands per 30 sec | Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery |
|
|
|
| Secondary | Walking Speed | Normal walking speed was measured over 10 meters. | Posted | Median | 95% Confidence Interval | m/s | Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery |
|
|
|
| Secondary | Postoperative Complications | Clavien-Dindo, number of participants with at least one postoperative complication. | Posted | Count of Participants | Participants | Within the first 30 days of surgery |
|
|
|
| Secondary | Length of Stay | Number of days admitted to the hospital | Posted | Median | Inter-Quartile Range | Days | At discharge, 2-4 weeks after baseline |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 3 |
| 10 |
| EG001 | Control Group | The participants will receive ordinary preoperative information, but will also be encouraged to follow the recommendation of 150 minutes/week of moderate physical activity. | 0 | 11 | 0 | 11 | 0 | 11 |
| Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Joint pain |
|
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |