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Completed

NCT Number: NCT02895464

Feasibility of Home-based Preoperative Exercise in Older People

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stockholm South General Hospital

Stockholm, 11883, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise

Other

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 outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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

  1. Six-minute Walk

    Time frame: Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery

    Meters completed, effort estimated

  2. Inspiratory Muscle Strength

    Time frame: Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery

    Inspiratory muscle strength measured with MicroRPM.

  3. Chair-stand 30-sec

    Time frame: Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery

    Number of stands during 30 sec.

  4. Walking Speed

    Time frame: Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery

    Normal walking speed was measured over 10 meters.

  5. Postoperative Complications

    Time frame: Within the first 30 days of surgery

    Clavien-Dindo, number of participants with at least one postoperative complication.

  6. Length of Stay

    Time frame: At discharge, 2-4 weeks after baseline

    Number of days admitted to the hospital

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Stockholm South General Hospital

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 9, 2016
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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