Feasibility of Home-based Preoperative Exercise in Older People

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02895464
• Other study ID #: LS1311-1462
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: June 30, 2018

Study information

• Verified date: August 2018
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Sweden	Stockholm South General Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Stockholm South General Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	Number of participants included from eligible patients	Six months
Primary	Exercise compliance	Number of sessions attended out of planned sessions	At the end of the intervention, after 2-4 weeks
Primary	Acceptability	Patients and instructors satisfaction with the intervention measured with a survey	At the end of the intervention, after 2-4 weeks
Primary	Adverse events	Musculoskeletal-related events , cardiovascular episodes, falls and health care use	During the intervention, after 1-4 weeks
Secondary	Six-minute walk	Meters completed, effort estimated	Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery
Secondary	Inspiratory muscle strength		Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery
Secondary	Chair-stand 30-sec	Number	Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery
Secondary	Walking speed (hab/max)	10 meters	Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery
Secondary	Postoperative complications	Clavien-Dindo, Delirium, Mortality	Within the first 30 days of surgery
Secondary	Length of stay		At discharge, 2-4 weeks after baseline
Secondary	Discharge destination	Care level after discharge from hospital (Home/Geriatric Clinic/Nursing Home)	At discharge, 2-4 weeks after baseline