An interventional study of Exercise in Colorectal Cancer, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2025-03-25.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Other
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,458 are open to participants now.
This study's enrollment of 23 is below the median of 77 across 4,122 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.
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Exclusion Criteria:
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.
Other: Exercise
The participants will receive ordinary preoperative information, but will also be encouraged to follow the recommendation of 150 minutes/week of moderate physical activity.
Other: Exercise
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.
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: During the intervention, after 1-4 weeks
Six-minute Walk
Meters completed, effort estimated
Time frame: Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery
Inspiratory Muscle Strength
Inspiratory muscle strength measured with MicroRPM.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Within the first 30 days of surgery
Length of Stay
Number of days admitted to the hospital
Time frame: At discharge, 2-4 weeks after baseline
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).
| Milestone | Exercise Group | Control Group |
|---|---|---|
| Started | 11 | 12 |
| Completed | 10 | 11 |
| Not completed | 1 | 1 |
| Milestone | Exercise Group | Control Group |
|---|---|---|
| Started | 10 | 11 |
| Completed | 10 | 11 |
| Not completed | 0 | 0 |
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).
| Participants | Overall Study |
|---|---|
| Exercise | 11 |
| Control | 12 |
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.
| Number of exercise sessions | Planned Exercise Sessions | Attended Exercise Sessions |
|---|---|---|
| Exercise Compliance | 60 | 58 |
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.
| Participants | Patients | Instructors |
|---|---|---|
| Acceptability | 10 | 5 |
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.
| Participants | Exercise Group |
|---|---|
| Adverse Events | 3 |
Meters completed, effort estimated
| meter | Exercise Group | Control Group |
|---|---|---|
| Six-minute Walk | 15 (-29 to 46) | -4 (-16 to 20) |
Inspiratory muscle strength measured with MicroRPM.
| cm H2O | Exercise Group | Control Gorup |
|---|---|---|
| Inspiratory Muscle Strength | 17 (7 to 25) | -2 (-6 to 4) |
Number of stands during 30 sec.
| Stands per 30 sec | Exercise Group | Control Group |
|---|---|---|
| Chair-stand 30-sec | 3.5 (0 to 4) | 1 (-0.3 to 3.3) |
Normal walking speed was measured over 10 meters.
| m/s | Exercise Group | Control Group |
|---|---|---|
| Walking Speed | 0.09 (0 to 0.3) | 0.09 (-0.002 to 0.13) |
Clavien-Dindo, number of participants with at least one postoperative complication.
| Participants | Exercise Group | Control Group |
|---|---|---|
| Postoperative Complications | 6 | 2 |
Number of days admitted to the hospital
| Days | Exercise Group | Control Group |
|---|---|---|
| Length of Stay | 5 (4 to 6) | 6 (4 to 7) |
Collected over Three weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Exercise Group | 0/10 (0%) | 0/10 (0%) | 3/10 (30%) |
| Control Group | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Event | Exercise Group | Control Group |
|---|---|---|
| PainMusculoskeletal and connective tissue disorders | 2/10 | 0/11 |
| DizzinessVascular disorders | 1/10 | 0/11 |
| Age, Customized(years) | Exercise Group | Control Group | Total |
|---|---|---|---|
| Median | 83.5 (76 to 85) | 74 (73 to 76) | 76 (73 to 84) |
| Sex: Female, Male(Participants) | Exercise Group | Control Group | Total |
|---|---|---|---|
| Female | 6 | 7 | 13 |
| Male | 4 | 4 | 8 |
| Race and Ethnicity Not Collected(Participants) | Exercise Group | Control Group | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | Exercise Group | Control Group | Total |
|---|---|---|---|
| Sweden | 10 | 11 | 21 |
| Type of surgery approach(Participants) | Exercise Group | Control Group | Total |
|---|---|---|---|
| Open | 3 | 3 | 6 |
| Laparoscopic | 7 | 8 | 15 |
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