Prevention of Functional and Cognitive Impairment in Hospitalized Oncogeriatric Patients

NCT ID: NCT05424055

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2024-03-21

Brief Summary

Hospitalized older patients usually remain bedridden for many hours and this may lead to the appearance of unwanted negative consequences, such as cognitive or physical decline upon discharge. Our study will analyze whether an intervention consisting of a multicomponent training programme applied to patients over the age of 60 who are hospitalized for acute medical conditions in an Oncology Department of a tertiary hospital improves functional capacity and cognitive function. A total of 50 hospitalized older adult patients will be recruited in the Hospital Universitario de Navarra, Pamplona, Spain. The participants will be randomized and included in an exercise intervention (n = 25) or a control (n = 25) group (hospital usual-care). The intervention consists of a multicomponent exercise training programme that will take place for 3 consecutive days (2 sessions/day). The control group will receive usual hospital care, which will include physical rehabilitation when needed. Functional and cognitive impairment after and during acute hospitalization in older adults are major determinants of the later need for health resources. If our hypothesis is correct and shows that a multicomponent, individualized and progressive exercise programme is an effective therapy for improving the functional capacity of acutely hospitalized older patients compared to usual care, a change in the current system of hospitalization may be justified in oncogeriatric patients with medical conditions

Conditions

Cancer; Hospital Acquired Condition; Debility; Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Multicomponent Exercise

The intervention will consist of a multicomponent exercise training programme, which will include supervised progressive resistance exercise training, balance training, and walking for 3 consecutive days. During the training period, patients will be trained in 20-minute sessions twice a day (morning and evening).

Group Type: EXPERIMENTAL

Multicomponent exercise

Intervention Type: BEHAVIORAL

The intervention will consist of a multicomponent exercise training programme, which will include supervised progressive resistance exercise training, balance-training and walking for 3 consecutive days. During the training period, patients will be trained in 20-minute sessions twice a day (morning and evening). The supervised multicomponent exercise training programme will be comprised of upper and lower body strengthening exercises, tailored to the individual's functional capacity, using weight machines and aiming for 2-3 sets of 8-10 repetitions at an intensity of 40-60 % of 1RM (Matrix, Johnson Health Tech, Ibérica, S.L., Madrid, Spain) combined with balance and gait retraining exercises that will progress in difficulty and functional exercises, such as rises from a chair. The second part of the session will consist of functional exercises such as knee extension and flexion, hip abduction, balance movements, and daily walking in the hospital.

Usual care

Participants randomly assigned to the usual care group will receive normal hospital care, including physical rehabilitation when needed

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Multicomponent exercise

The intervention will consist of a multicomponent exercise training programme, which will include supervised progressive resistance exercise training, balance-training and walking for 3 consecutive days. During the training period, patients will be trained in 20-minute sessions twice a day (morning and evening). The supervised multicomponent exercise training programme will be comprised of upper and lower body strengthening exercises, tailored to the individual's functional capacity, using weight machines and aiming for 2-3 sets of 8-10 repetitions at an intensity of 40-60 % of 1RM (Matrix, Johnson Health Tech, Ibérica, S.L., Madrid, Spain) combined with balance and gait retraining exercises that will progress in difficulty and functional exercises, such as rises from a chair. The second part of the session will consist of functional exercises such as knee extension and flexion, hip abduction, balance movements, and daily walking in the hospital.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age > 65 years
• Barthel Index ≥60 points
• Able to ambulate (with/without assistance)
• Sign the informed consent
• Able to communicate

Exclusion Criteria

• Expected length of stay < 6 days
• Terminal illness
• Very severe cognitive decline (i.e., GDS 7)
• Uncontrolled arrhythmias, acute pulmonary embolism, acute myocardial infarction or limb bone fracture in the past 3 months.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundacion Miguel Servet

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

NICOLA MARTINEZ-VELILLA, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital of Navarra

Locations

Hospital Universitario de Navarra

Pamplona, Navarre, Spain

Countries

Spain

Other Identifiers

ONCOGERI-ACUTE

Identifier Type: -

Identifier Source: org_study_id