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Feasibility of Home-based Preoperative Exercise in Older People

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Exercise
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Colorectal Cancer

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stockholm South General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Exercise group

Control group

Arm Description

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.

The participants will receive ordinary preoperative information, but will also be encouraged to follow the recommendation of 150 minutes/week of moderate physical activity.

Outcomes

Primary Outcome Measures

Recruitment rate
Number of participants included from eligible patients
Exercise compliance
Number of sessions attended out of planned sessions
Acceptability
Patients and instructors satisfaction with the intervention measured with a survey
Adverse events
Musculoskeletal-related events , cardiovascular episodes, falls and health care use

Secondary Outcome Measures

Six-minute walk
Meters completed, effort estimated
Inspiratory muscle strength
Chair-stand 30-sec
Number
Walking speed (hab/max)
10 meters
Postoperative complications
Clavien-Dindo, Delirium, Mortality
Length of stay
Discharge destination
Care level after discharge from hospital (Home/Geriatric Clinic/Nursing Home)

Full Information

First Posted
August 9, 2016
Last Updated
August 7, 2018
Sponsor
Karolinska Institutet
Collaborators
Stockholm South General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02895464
Brief Title
Feasibility of Home-based Preoperative Exercise in Older People
Official Title
Preoperative Home-based Exercise in Older People Before Colorectal Surgery - a Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Stockholm South General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Other
Arm Description
The participants will receive ordinary preoperative information, but will also be encouraged to follow the recommendation of 150 minutes/week of moderate physical activity.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recruitment rate
Description
Number of participants included from eligible patients
Time Frame
Six months
Title
Exercise compliance
Description
Number of sessions attended out of planned sessions
Time Frame
At the end of the intervention, after 2-4 weeks
Title
Acceptability
Description
Patients and instructors satisfaction with the intervention measured with a survey
Time Frame
At the end of the intervention, after 2-4 weeks
Title
Adverse events
Description
Musculoskeletal-related events , cardiovascular episodes, falls and health care use
Time Frame
During the intervention, after 1-4 weeks
Secondary Outcome Measure Information:
Title
Six-minute walk
Description
Meters completed, effort estimated
Time Frame
Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery
Title
Inspiratory muscle strength
Time Frame
Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery
Title
Chair-stand 30-sec
Description
Number
Time Frame
Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery
Title
Walking speed (hab/max)
Description
10 meters
Time Frame
Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery
Title
Postoperative complications
Description
Clavien-Dindo, Delirium, Mortality
Time Frame
Within the first 30 days of surgery
Title
Length of stay
Time Frame
At discharge, 2-4 weeks after baseline
Title
Discharge destination
Description
Care level after discharge from hospital (Home/Geriatric Clinic/Nursing Home)
Time Frame
At discharge, 2-4 weeks after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Stockholm South General Hospital
City
Stockholm
ZIP/Postal Code
11883
Country
Sweden

12. IPD Sharing Statement

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Feasibility of Home-based Preoperative Exercise in Older People

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