NCT07723339

Brief Summary

This study aims to evaluate the effects of a home intervention of individualized multicomponent physical exercise program (including strength, balance, flexibility, and mobility training) on functional health, physical capacity, and biological markers in centenarians. The intervention includes periodic monitoring and individualized exercise progression every three weeks.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
16mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Jun 2026Dec 2027

Study Start

First participant enrolled

June 12, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 16, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 23, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

July 23, 2026

Status Verified

July 1, 2026

Enrollment Period

1.5 years

First QC Date

July 16, 2026

Last Update Submit

July 22, 2026

Conditions

AgingCellular SenescenceBiomarkers / BloodExerciseFrailty

Keywords

CentenariansHealthy agingSenescenceLongevityPersonalized medicinePreventive medicineOmics technologies (genomics, proteomics, metabolomics)Artificial intelligence in healthcareExercise

Outcome Measures

Primary Outcomes (1)

  • Physical function assessed by Short Physical Performance Battery (SPPB)

    Physical Function: Assessed using the Short Physical Performance Battery (SPPB), which combines balance, gait velocity, and leg strength as a single score on a 0 (worst) to 12 (best scale).

    Baseline and 12-week follow-up

Secondary Outcomes (21)

  • Health-related quality of life index score assessed by the EQ-5D-5L

    Baseline and 12-week follow-up

  • Patient self-rated health status assessed by the EQ-5D-5L VAS

    Baseline and 12-week follow-up

  • Functional status measured with Barthel Index

    Baseline and 12-week follow-up

  • Cognitive Function assessed with Mini Mental State Examination (MMSE)

    Baseline and 12-week follow-up

  • Hand Grip Strength

    Baseline and 12-week follow-up

  • +16 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

Participants assigned to the control group will receive usual care and will not undergo any specific intervention related to individualized multicomponent exerceise. They will continue doing their daily routine.

Exercise

EXPERIMENTAL

Participants in this group will take part in a individualized multicomponent physical training program including exercises targeting strength, balance, and aerobic capacity, adapted to centenarians and conducted following established safety guidelines.

Other: Exercise

Interventions

ExerciseOTHER

Participants in the intervention group will take part in an individualized multicomponent physical training program including exercises targeting strength, balance, and aerobic capacity, adapted to older adults and conducted following established safety guidelines.

Also known as: Group 1
Exercise

Eligibility Criteria

Age100 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Individuals aged ≥ 100 years;
  • Residents of Navarre.;
  • Barthel Index score ≥ 60, capable of standing and performing transfers independently or with minimal assistance;
  • Stable clinical condition;
  • Ability to follow simple instructions;
  • Signed informed consent (by the participant or legal representative).

You may not qualify if:

  • Acute illness or unstable chronic condition, clinical decompensation within the last month: hemodynamic instability, acute pathology, hospitalization;
  • Severe cardiovascular or respiratory pathology that contraindicates exercise;
  • Severe cognitive impairment preventing participation;
  • Recent fracture or major surgery (\< 3 months).
  • Individuals in an end-of-life situation, defined as a clinical state of irreversible decline with a life expectancy of less than weeks or months, according to medical criteria.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Navarrabiomed

Pamplona, Navarre, 31001, Spain

Location

MeSH Terms

Conditions

Motor ActivityFrailty

Interventions

Exercise

Condition Hierarchy (Ancestors)

BehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Nicolas Martínez Velilla, MD and PhD

    Navarrabiomed, Hospital Universitario de Navarra, IdisNa, Universidad Pública de Navarra

    PRINCIPAL INVESTIGATOR

  • Chenhui Chen, MD

    Navarrabiomed, Hospital Universitario de Navarra, IdisNa, Universidad Pública de Navarra

    STUDY DIRECTOR

  • Enrique Santamaría, PhD

    Navarrabiomed, Hospital Universitario de Navarra, IdisNa, Universidad Pública de Navarra

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial (RCT)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2026

First Posted

July 23, 2026

Study Start

June 12, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

July 23, 2026

Record last verified: 2026-07

Locations

ES(1)