Colorectal Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERExercise
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.
Sponsors
Karolinska Institutet
Stockholm South General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age above 70, understand and speaks the Swedish language. Surgery due to cancer
Exclusion criteria
* Health status that contradicts participation in the study such as unstable heart disease or severe orthopaedic conditions that prohibits training and severe systematic illness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Rate | Baseline | 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). |
| Exercise Compliance | At the end of the intervention, after 2-4 weeks | 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. |
| Acceptability | At the end of the intervention, after 2-4 weeks | 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. |
| Adverse Events | During the intervention, after 1-4 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Complications | Within the first 30 days of surgery | Clavien-Dindo, number of participants with at least one postoperative complication. |
| Six-minute Walk | Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery | Meters completed, effort estimated |
| Length of Stay | At discharge, 2-4 weeks after baseline | Number of days admitted to the hospital |
| Inspiratory Muscle Strength | Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery | Inspiratory muscle strength measured with MicroRPM. |
| Chair-stand 30-sec | Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery | Number of stands during 30 sec. |
| Walking Speed | Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery | Normal walking speed was measured over 10 meters. |
Countries
Sweden
Participant flow
Recruitment details
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).
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| 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. | 11 |
| Total | 21 |
Baseline characteristics
| Characteristic | Exercise Group | Control Group | Total |
|---|---|---|---|
| Age, Customized | 83.5 years | 74 years | 76 years |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Sweden | 10 Participants | 11 Participants | 21 Participants |
| Sex: Female, Male Female | 6 Participants | 7 Participants | 13 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 8 Participants |
| Type of surgery approach Laparoscopic | 7 Participants | 8 Participants | 15 Participants |
| Type of surgery approach Open | 3 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 11 |
| other Total, other adverse events | 3 / 10 | 0 / 11 |
| serious Total, serious adverse events | 0 / 10 | 0 / 11 |
Outcome results
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.
Time frame: At the end of the intervention, after 2-4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Overall Study | Acceptability | 10 Participants |
| Attended Exercise Sessions | Acceptability | 5 Participants |
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.
Time frame: During the intervention, after 1-4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Overall Study | Adverse Events | 3 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.
Time frame: At the end of the intervention, after 2-4 weeks
Population: The number of planned sessions and attended sessions.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Overall Study | Exercise Compliance | 60 Number of exercise sessions |
| Attended Exercise Sessions | Exercise Compliance | 58 Number of exercise sessions |
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).
Time frame: Baseline
Population: 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).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Overall Study | Recruitment Rate | Exercise | 11 Participants |
| Overall Study | Recruitment Rate | Control | 12 Participants |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Overall Study | Chair-stand 30-sec | 3.5 Stands per 30 sec |
| Attended Exercise Sessions | Chair-stand 30-sec | 1 Stands per 30 sec |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Overall Study | Inspiratory Muscle Strength | 17 cm H2O |
| Attended Exercise Sessions | Inspiratory Muscle Strength | -2 cm H2O |
Secondary
Length of Stay
Number of days admitted to the hospital
Time frame: At discharge, 2-4 weeks after baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Overall Study | Length of Stay | 5 Days |
| Attended Exercise Sessions | Length of Stay | 6 Days |
Secondary
Postoperative Complications
Clavien-Dindo, number of participants with at least one postoperative complication.
Time frame: Within the first 30 days of surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Overall Study | Postoperative Complications | 6 Participants |
| Attended Exercise Sessions | Postoperative Complications | 2 Participants |
Secondary
Six-minute Walk
Meters completed, effort estimated
Time frame: Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Overall Study | Six-minute Walk | 15 meter |
| Attended Exercise Sessions | Six-minute Walk | -4 meter |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Overall Study | Walking Speed | 0.09 m/s |
| Attended Exercise Sessions | Walking Speed | 0.09 m/s |