Prevention of Functional and Cognitive Impairment in Hospitalized Oncogeriatric Patients

NCT05424055 | Completed

• 1 other identifier: ONCOGERI-ACUTE
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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

Keywords

Multicomponent exercise; Oncogeriatric; Hospitalization

Outcome Measures

Primary Outcomes (2)

• Change in functional capacity: Short Physical Performance Battery test (SPPB; Spanish versión)

  The change in SPPB measured at baseline and follow-up (a measure of balance, gait, and rising from a chair) Minimum 1 Maximum 12 Higher scores mean a better outcome

  12 months

• Change in cognitive function: Minimental State Evaluation (MMSE; Spanish version)

  The change in MMSE will be measured at baseline and follow-up. Minimum 1 Maximum 35 Higher scores mean a better outcome

  12 months

Secondary Outcomes (7)

• Change in functional capacity: Barthel Index (spanish version)

  12 months

• Changes in handgrip strength (dominant hand)

  12 months

• Gait ability will be assessed using the 6-metre gait velocity test (GVT)

  12 months

• Changes in mood status: the 15-item Yesavage Geriatric Depression Scale (GDS-VE), Spanish version

  12 months

• Changes in the Trail Making Test (TMT) part A

  12 months

Study Arms (2)

Multicomponent Exercise

EXPERIMENTAL

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).

Behavioral: Multicomponent exercise

Usual care

NO INTERVENTION

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

Interventions

Multicomponent exercise 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.

Multicomponent Exercise

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion Miguel Servet: lead

Study Sites (1)

Hospital Universitario de Navarra

Pamplona, Navarre, 31008, Spain

Location

MeSH Terms

Conditions

Neoplasms; Iatrogenic Disease; Frailty

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• NICOLA MARTINEZ-VELILLA, PhD

  Hospital of Navarra

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 21, 2022
• Study Start: December 1, 2020
• Primary Completion: March 21, 2024
• Study Completion: March 21, 2024
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After the publication of the first article. No limit of time for reasonable requests

Locations

ES (1)