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CancerNCT05424055

Prevention of Functional and Cognitive Impairment in Hospitalized Oncogeriatric Patients

A study testing Multicomponent exercise in people with Cancer and Hospital Acquired Condition, run by Fundacion Miguel Servet at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Cancer, Hospital Acquired Condition, Debility
What is being tested?
Multicomponent exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteSpain
Study dates
1 Dec 2020to 21 Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Universitario de Navarra

    Pamplona, Navarre, 31008

Other trials in Spain

About this study

Official title: Prevention of Functional and Cognitive Impairment Through a Multicomponent Exercise Program in Hospitalized Oncogeriatric Patients

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

Being tested
Multicomponent exercise
Keywords
Multicomponent exercise, Oncogeriatric, Hospitalization
Medical subject headings
Neoplasms, Iatrogenic Disease, Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multicomponent exerciseBehavioural

    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.

Study groups in NCT05424055
Study groupRoleWhat they receive
Multicomponent ExerciseExperimentalThe 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).
Receives: Behavioral: Multicomponent exercise
Usual careNo interventionParticipants randomly assigned to the usual care group will receive normal hospital care, including physical rehabilitation when needed

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12 months

  2. 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

    Measured: 12 months

Secondary outcomes (7)

  1. Change in functional capacity: Barthel Index (spanish version)

    The change in Barthel Index measured at baseline and follow-up (a measure of Basic Activities of Daily Living) Minimum 0 Maximum 100 Higher scores mean a better outcome

    Measured: 12 months

  2. Changes in handgrip strength (dominant hand)

    The change in handgrip strength at baseline and follow-up

    Measured: 12 months

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

    The change in gait velocity test measured at baseline and follow-up

    Measured: 12 months

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

    The change in Yesavage Geriatric Depression Scale measured at baseline and follow-up

    Measured: 12 months

  5. Changes in the Trail Making Test (TMT) part A

    The change in Trail Making Test measured at baseline and follow-up. Minimum 0 Results are reported as the number of seconds required to complete the task; higher scores reveal greater impairment.

    Measured: 12 months

  6. Dual task GVT (verbal GVT and arithmetic GVT)

    The change in Dual task measured at baseline and follow-up. During the verbal dual-task test the investigarors will measure the gait velocity while participants name animals aloud. The cognitive score wil be measured by counting the number of animals named (verbal dual task) or by counting the numbers that were stated (arithmetic dual task) and the errors in each task. Minimum 0 Higher scores reveal greater impairment.

    Measured: 12 months

  7. Changes in the quality of life measured by the Spanish version of the EuroQol-5 Dimension (EQ-5D) questionnaire

    The change in EuroQol-5 Dimension (EQ-5D) questionnaire, measured at baseline and follow-up.

    The EQ records the respondent's overall current health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine' Minimum 0 Maximum 100 Higher scores mean a better outcome

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2022
  2. Study start1 Dec 2020
  3. Primary completion21 Mar 2024
  4. Study completion21 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Sequential
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05424055
Sponsor's protocol ID
ONCOGERI-ACUTE
Status last verified
Jan 2025
First submitted
14 Jun 2022
Last updated
13 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data that support the findings of this study will be available upon reasonable request to the corresponding author.

Publications

  • Ferrara MC, Zambom-Ferraresi F, Castillo A, Delgado M, Galbete A, Arrazubi V, Morilla I, Zambom-Ferraresi F, Fernandez Gonzalez de la Riva ML, Vera Garcia R, Martinez-Velilla N. Effects of an individualised exercise program in hospitalised older adults with cancer: A randomised clinical trial. J Nutr Health Aging. 2025 Jan;29(1):100424. doi: 10.1016/j.jnha.2024.100424. Epub 2024 Nov 29.

    PubMed 39615400

Questions about this trial

What is this clinical trial studying?

A study testing Multicomponent exercise in people with Cancer and Hospital Acquired Condition, run by Fundacion Miguel Servet at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in functional capacity: Short Physical Performance Battery test (SPPB; Spanish versión) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05424055, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.

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