Feasibility of Home-based Preoperative Exercise in Older People

NCT02895464 | Completed Results

• 1 other identifier: LS1311-1462
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (4)

• Recruitment Rate

  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).

  Baseline

• Exercise Compliance

  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.

  At the end of the intervention, after 2-4 weeks

• Acceptability

  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.

  At the end of the intervention, after 2-4 weeks

• Adverse Events

  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.

  During the intervention, after 1-4 weeks

Secondary Outcomes (6)

• 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

Study Arms (2)

Exercise group

EXPERIMENTAL

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.

Other: Exercise

Control group

OTHER

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

Other: Exercise

Interventions

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.

Control group; Exercise group

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age above 70, understand and speaks the Swedish language. Surgery due to cancer

You may not qualify if:

• Health status that contradicts participation in the study such as unstable heart disease or severe orthopaedic conditions that prohibits training and severe systematic illness.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Stockholm South General Hospital: collaborator

Study Sites (1)

Stockholm South General Hospital

Stockholm, 11883, Sweden

Location

Related Publications (1)

• 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.

  PMID: 31265476 RESULT

Related Links

• Feasibility of preoperative supervised homebased exercise in older adults undergoing colorectal cancer surgery - A randomized controlled design

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dr Elisabeth Rydwik
• Organization: Karolinska Institutet

elisabeth.rydwik@ki.se

+46852488818

Study Officials

• Elisabeth Rydwik, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: September 9, 2016
• Study Start: September 1, 2016
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: March 25, 2025
• Results First Posted: March 25, 2025

Record last verified: 2025-03

Locations

SE (1)