Oncologic DiseaseNCT07617714
Adapted Physical Activity (APA) Following Hospitalization in Frail Older Adults
A study testing Adapted Physical Activity Program and routine care in people with Oncologic Disease, run by Biobizkaia Health Research Institute.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Oncologic Disease
- What is being tested?
- Adapted Physical Activity Program and routine care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Oncologic Disease
- Being tested
- Adapted Physical Activity Program, routine care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted Physical Activity ProgramOther
a 14-week Adapted Physical Activity (APA) program following hospital discharge
routine careOther
Participants in the control group will receive standard post-discharge care, along with general recommendations for physical activity and healthy lifestyle habits
| Study group | Role | What they receive |
|---|---|---|
| Adapted Physical Activity Program | Other | Not described Receives: Other: Adapted Physical Activity Program |
| routine care | Other | Not described Receives: Other: routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in overall physical function assessed by changes in the Short Physical Performance Battery (SPPB) score."
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study startJun 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oncologic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biobizkaia Health Research Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07617714
- Sponsor's protocol ID
- SHAPE
- Status last verified
- Jun 2026
- First submitted
- 22 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapted Physical Activity (APA) Following Hospitalization in Frail Older Adults
- ClinicalTrials.gov ID
- NCT07617714
- Acronym / sponsor ID
- SHAPE
- Conditions
- Oncologic Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Biobizkaia Health Research InstituteOther government
- Study start
- Jun 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adapted Physical Activity Program | Other | Other: Adapted Physical Activity Program |
| routine care | Other | Other: routine care |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapted Physical Activity Programa 14-week Adapted Physical Activity (APA) program following hospital discharge | Other | Adapted Physical Activity Program |
| routine careParticipants in the control group will receive standard post-discharge care, along with general recommendations for physical activity and healthy lifestyle habits | Other | routine care |
Primary outcome
Improvement in overall physical function assessed by changes in the Short Physical Performance Battery (SPPB) score."
Time frame: 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted Physical Activity Program and routine care in people with Oncologic Disease, run by Biobizkaia Health Research Institute.
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 6 inclusion and 10 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: opening soon, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elena Galve, Doctor (944006000, elena.galvecalvo@osakidetza.eus), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in overall physical function assessed by changes in the Short Physical Performance Battery (SPPB) score." (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jun 2026.