Adapted Physical Activity (APA) Following Hospitalization in Frail Older Adults

To evaluate the effectiveness of an Adapted Physical Activity (APA) program in improving functional capacity and reducing frailty in older adults following hospital discharge.

The aim is to determine whether a structured program of personalized exercises improves mobility, strength, and quality of life compared to standard care.

Study Overview

• Status: Not yet recruiting
• Conditions: Oncologic Disease
• Intervention / Treatment: Other: Adapted Physical Activity Program; Other: routine care

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elena Galve, Doctor; Phone Number: 944006000; Email: elena.galvecalvo@osakidetza.eus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The study is open to individuals aged 65 and older.
• Current diagnosis or recent history of cancer.
• Patients currently undergoing treatment (chemotherapy, immunotherapy, targeted therapy) or in follow-up after recent treatment (≤12 months since completion).
• Functional capacity compatible with participation in an adapted physical activity program, as determined by clinical assessment.
• Recent hospitalization: Patients must have been discharged following a hospital stay.
• Frailty: Presence of a significant level of frailty at hospital discharge.

Exclusion Criteria:

• Short Physical Performance Battery> 10: Patients considered "robust" are excluded to maximize the relevance of the intervention.
• Acute unstable medical condition or contraindication to exercise: Any unstabilized acute condition that makes physical activity dangerous (e.g., acute cardiac complication, ongoing severe infection). Recent major medical events (myocardial infarction, major surgery, bone fracture, or major amputation in the past few weeks) will also be excluded.
• Severe chronic conditions incompatible with exercise: Severe progressive diseases that prevent safe exercise, such as severe neuromuscular diseases or advanced organ failure (e.g., end-stage renal failure).
• Short-term life-threatening prognosis: Patients in the terminal phase or with a very limited life expectancy (less than 6 months).
• Total functional dependence or severe motor impairment: Patients who are completely dependent for basic activities (very low Barthel Index, e.g., <20/100) or who are unable to move even minimally (e.g., unable to walk a few steps or stand, even with assistance).
• Severe cognitive impairment: Severe cognitive impairment (e.g., advanced dementia without the ability to follow simple instructions) that prevents active participation in the program.
• Severe sensory or communication disorders: Significant sensory impairments-such as profound uncompensated blindness or deafness-or any communication barrier (severe aphasia, language barrier) that prevents participation in the program, unless a caregiver (family member or professional) can be present to ensure safety during the exercises.
• Institutionalization of the patient: Individuals who do not live in their usual residence are excluded. The study focuses on older adults returning home, as the institutional setting involves different care.
• Lack of valid informed consent: Any patient who refuses to participate or who cannot provide valid consent (due to lack of legal capacity or understanding) will be excluded.
• Participation in another concurrent program or trial: Simultaneous participation in another physical exercise program or trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Adapted Physical Activity Program	Other: Adapted Physical Activity Program; a 14-week Adapted Physical Activity (APA) program following hospital discharge
Other: routine care	Other: routine care; Participants in the control group will receive standard post-discharge care, along with general recommendations for physical activity and healthy lifestyle habits

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Improvement in overall physical function assessed by changes in the Short Physical Performance Battery (SPPB) score."	4 months

Collaborators and Investigators

• Sponsor: Biobizkaia Health Research Institute

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: May 22, 2026
• First Submitted That Met QC Criteria: May 29, 2026
• First Posted (Actual): June 1, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: SHAPE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No