Feasibility of Home-based Preoperative Exercise in Older People

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Preoperative Home-based Exercise in Older People Before Colorectal Surgery - a Feasibility Study

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Other: Exercise


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise group<br>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<br>* 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.<br>|
| Other: Control group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rate | Number of participants included from eligible patients | Six months | 
| Exercise compliance | Number of sessions attended out of planned sessions | At the end of the intervention, after 2-4 weeks | 
| Acceptability | Patients and instructors satisfaction with the intervention measured with a survey | At the end of the intervention, after 2-4 weeks | 
| Adverse events | Musculoskeletal-related events , cardiovascular episodes, falls and health care use | During the intervention, after 1-4 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery | 
| Chair-stand 30-sec | Number | Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery | 
| Walking speed (hab/max) | 10 meters | Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery | 
| Postoperative complications | Clavien-Dindo, Delirium, Mortality | Within the first 30 days of surgery | 
| Length of stay |  | At discharge, 2-4 weeks after baseline | 
| Discharge destination | Care level after discharge from hospital (Home/Geriatric Clinic/Nursing Home) | At discharge, 2-4 weeks after baseline |