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Clinical Trials/NCT02895464
NCT02895464
Completed
N/A

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

Karolinska Institutet1 site in 1 country23 target enrollmentSeptember 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Colorectal Cancer
Sponsor
Karolinska Institutet
Enrollment
23
Locations
1
Primary Endpoint
Recruitment Rate
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2016
End Date
June 30, 2018
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Elisabeth Rydwik

Associate professor

Karolinska Institutet

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.

Outcomes

Primary Outcomes

Recruitment Rate

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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 Outcomes

  • Six-minute Walk(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(Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery)
  • Walking Speed(Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery)
  • Postoperative Complications(Within the first 30 days of surgery)
  • Length of Stay(At discharge, 2-4 weeks after baseline)

Study Sites (1)

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