Clinical trial NCT02895464: 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
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Stockholm South General Hospital
First posted: 2016-09-09
Enrollment: 23
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Recruitment Rate
timeFrame: Baseline
measure: Exercise Compliance
timeFrame: At the end of the intervention, after 2-4 weeks
measure: Acceptability
timeFrame: At the end of the intervention, after 2-4 weeks
measure: Adverse Events
timeFrame: During the intervention, after 1-4 weeks
Secondary outcomes:
measure: Six-minute Walk
timeFrame: Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery
measure: Inspiratory Muscle Strength
timeFrame: Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery
measure: Chair-stand 30-sec
timeFrame: Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery
measure: Walking Speed
timeFrame: Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery
measure: Postoperative Complications
timeFrame: Within the first 30 days of surgery
measure: Length of Stay
timeFrame: At discharge, 2-4 weeks after baseline
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Stockholm South General Hospital
Study officials:
affiliation: Karolinska Institutet
name: Elisabeth Rydwik, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Karlsson E, Farahnak P, Franzen E, Nygren-Bonnier M, Dronkers J, van Meeteren N, Rydwik E. Feasibility of preoperative supervised home-based exercise in older adults undergoing colorectal cancer surgery - A randomized controlled design. PLoS One. 2019 Jul 2;14(7):e0219158. doi: 10.1371/journal.pone.0219158. eCollection 2019.