Prevention of Functional and Cognitive Impairment in Hospitalized Oncogeriatric Patients

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05424055
• Other study ID #: ONCOGERI-ACUTE
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: June 2022
• Source: Fundacion Miguel Servet
• Contact: Nicolas Martinez-Velilla, PhD
• Phone: +34670900434
• Email: nicolas.martinez.velilla[@]navarra.es
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aging
• Cancer
• Cognitive Dysfunction
• Debility
• Frailty
• Hospital Acquired Condition
• Iatrogenic Disease

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Spain	Hospital Universitario de Navarra	Pamplona	Navarra

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion Miguel Servet

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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	12 months
Secondary	Changes in handgrip strength (dominant hand)	The change in handgrip strength at baseline and follow-up	12 months
Secondary	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	12 months
Secondary	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	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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	12 months