NCT07112638

Brief Summary

The engAGE project is an innovative, non-oriented research initiative that seeks to advance public health knowledge to promote quality of life and functional independence in older adults. It combines expertise in public health, education, pedagogy, psychology, and technology with a novel approach. The project is divided in two phases: Phase 1: Involves the co-creation of an intergenerational intervention designed to improve movement patterns of community-dwelling older adults (65+), recruited from community and day care centres. Using participatory action research, interventions will be co-designed with older adults, family members (including children and grandchildren), students, health and education professionals, technology experts, and researchers. The reserachers aim is to reduce sedentary behaviour (SB), increase physical activity (PA), and explore the added value of immersive technology to enhance uptake, adherence, and sustainability. Phase 2: Evaluate the effects of the tailored, co-created intervention through a randomised controlled clinical trial. Movement patterns will be assessed via accelerometry and observational measures (time in SB, active vs. passive SB, standing, walking, steps, and transitions) at baseline, post-intervention, 6 months, and 12 months. In addition to movement outcomes, secondary measures will include functional capacity, independence, loneliness, social isolation, physical function, body composition, quality of life, depression, anxiety, and cost-utility.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Feb 2025

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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 Progress66%
Feb 2025Jan 2027

Study Start

First participant enrolled

February 3, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 8, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

December 5, 2025

Status Verified

November 1, 2025

Enrollment Period

1.3 years

First QC Date

August 1, 2025

Last Update Submit

November 27, 2025

Conditions

Keywords

co-creationintergenerationalphysical activitysedentary behaviorolder adults

Outcome Measures

Primary Outcomes (1)

  • sedentary behavior

    Change in sedentary behavior mesured by the change in the register pre and post intervention with the activePAL device and the use of sedentary behavior questionaire (SBQ). SBQ: Each item rated on a 9-point scale of daily time spent in sedentary activities (0 = none, 8 = ≥6 hours). Total score = sum of minutes across items. Range: 0-3240 minutes/day. Higher scores = worse outcome (more sedentary time). Lower scores = better outcome (less sedentary time).

    From enrollment to the end of the intervention at 12 weeks + 6 months follow-up + 1 year follow-up.

Study Arms (2)

Intervention: Immersive virtual reality + exercise

EXPERIMENTAL

Intervention: Immersive virtual reality + phisical exercises

Other: immersive technology-based intergenerational intervention to improve movement patterns in older adults

Control

NO INTERVENTION

workshops including story telling, origami and yoga

Interventions

Intervention group The intervention consists of 60-minute supervised sessions conducted once per week for 12 weeks. Each session begins with a 10-minute warm-up, followed by 15 minutes of strength training. Four structured session types (A, B, C, and D) were designed and are being rotated throughout the 12-week period. These sessions incorporate upper and lower body exercises performed using body weight and/or resistance bands, adapted to each participant's physical function.

Intervention: Immersive virtual reality + exercise

Eligibility Criteria

Age65 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsLimited to biological sex.
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Aged 65 years or older.
  • Community-dwelling older adults.
  • Regular attendance at most sessions (at least 80% attendance).
  • Ability to move autonomously, with or without technical assistance.
  • Provision of informed consent.

You may not qualify if:

  • Presence of severe cognitive deficits, assessed by the Pfeiffer test (8 to 10 errors) (Martínez de la Iglesiaa et al., 2001).
  • Lack of participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Blanquerna - Ramon Llull University

Barcelona, Barcelona, 08022, Spain

Location

Universitat Blanquerna

Barcelona, Barcelona, 08022, Spain

Location

MeSH Terms

Conditions

Motor ActivitySedentary Behavior

Interventions

Aging

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Growth and DevelopmentPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2025

First Posted

August 8, 2025

Study Start

February 3, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

December 5, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations