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Prevention of Functional and Cognitive Impairment in Hospitalized Oncogeriatric Patients

Primary Purpose

Cancer, Hospital Acquired Condition, Debility

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Multicomponent exercise
Sponsored by
Fundacion Miguel Servet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cancer focused on measuring Multicomponent exercise, Oncogeriatric, Hospitalization

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Universitario de NavarraRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Multicomponent Exercise

Usual care

Arm Description

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).

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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
Changes in handgrip strength (dominant hand)
The change in handgrip strength at baseline and follow-up
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
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
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.
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.
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

Full Information

First Posted
June 14, 2022
Last Updated
June 17, 2022
Sponsor
Fundacion Miguel Servet
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1. Study Identification

Unique Protocol Identification Number
NCT05424055
Brief Title
Prevention of Functional and Cognitive Impairment in Hospitalized Oncogeriatric Patients
Official Title
Prevention of Functional and Cognitive Impairment Through a Multicomponent Exercise Program in Hospitalized Oncogeriatric Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacion Miguel Servet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Hospital Acquired Condition, Debility, Aging
Keywords
Multicomponent exercise, Oncogeriatric, Hospitalization

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Multicomponent Exercise
Arm Type
Experimental
Arm Description
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).
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Participants randomly assigned to the usual care group will receive normal hospital care, including physical rehabilitation when needed
Intervention Type
Behavioral
Intervention Name(s)
Multicomponent exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in functional capacity: Short Physical Performance Battery test (SPPB; Spanish versión)
Description
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
Time Frame
12 months
Title
Change in cognitive function: Minimental State Evaluation (MMSE; Spanish version)
Description
The change in MMSE will be measured at baseline and follow-up. Minimum 1 Maximum 35 Higher scores mean a better outcome
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in functional capacity: Barthel Index (spanish version)
Description
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
Time Frame
12 months
Title
Changes in handgrip strength (dominant hand)
Description
The change in handgrip strength at baseline and follow-up
Time Frame
12 months
Title
Gait ability will be assessed using the 6-metre gait velocity test (GVT)
Description
The change in gait velocity test measured at baseline and follow-up
Time Frame
12 months
Title
Changes in mood status: the 15-item Yesavage Geriatric Depression Scale (GDS-VE), Spanish version
Description
The change in Yesavage Geriatric Depression Scale measured at baseline and follow-up
Time Frame
12 months
Title
Changes in the Trail Making Test (TMT) part A
Description
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.
Time Frame
12 months
Title
Dual task GVT (verbal GVT and arithmetic GVT)
Description
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.
Time Frame
12 months
Title
Changes in the quality of life measured by the Spanish version of the EuroQol-5 Dimension (EQ-5D) questionnaire
Description
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
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas Martinez-Velilla, PhD
Phone
+34670900434
Email
nicolas.martinez.velilla@navarra.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
NICOLA MARTINEZ-VELILLA, PhD
Organizational Affiliation
Hospital Universitario de Navarra
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
NICOLAS MARTINEZ-VELILLA
Phone
0034670900434
Email
nicolas.martinez.velilla@navarra.es

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data that support the findings of this study will be available upon reasonable request to the corresponding author.
IPD Sharing Time Frame
After the publication of the first article. No limit of time for reasonable requests

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Prevention of Functional and Cognitive Impairment in Hospitalized Oncogeriatric Patients

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