NCT07199114

Brief Summary

This randomized, parallel-group clinical trial evaluates a 12-week adapted CrossFit program versus usual activity in community-dwelling older adults. The primary endpoint is change in Timed Up and Go (TUG) from baseline to 12 weeks. Secondary outcomes include Functional Reach (FRT), Romberg (eyes closed), gait velocity, stride length, and lower-limb power tests (Chair-Stand, Stair Ascent, Stair Descent; time and W/kg). Sixty participants were randomized (1:1). Analyses used repeated-measures ANOVA with Bonferroni adjustments and Cohen's d effect sizes.

Trial Health

87
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
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 30, 2025

Completed
Last Updated

September 30, 2025

Status Verified

September 1, 2025

Enrollment Period

5 months

First QC Date

September 22, 2025

Last Update Submit

September 22, 2025

Conditions

Keywords

Aging;postural balanceStrength Training Adaptations

Outcome Measures

Primary Outcomes (1)

  • Timed Up and Go (TUG), seconds

    Change in functional mobility. Shorter time indicates better performance and reduced risk of falls.

    Baseline and Week 12

Secondary Outcomes (8)

  • Functional Reach Test (FRT)

    Baseline and 12 weeks

  • Chair-Stand Test (CST)

    Baseline and 12 weeks

  • Fear of Falling (Falls Efficacy Scale-International, FES-I)

    Baseline and week 12

  • Sleep Quality (Pittsburgh Sleep Quality Index, PSQI)

    Baseline and week 12

  • Anxiety and Depression (Hospital Anxiety and Depression Scale, HADS)

    Baseline and week 12

  • +3 more secondary outcomes

Study Arms (2)

Adapted CrossFit Program

EXPERIMENTAL

Supervised, scaled functional multi-joint training tailored to older adults, combining strength and metabolic conditioning with progressive overload over 12 weeks.

Behavioral: Adapted CrossFit Program (12 weeks)

Usual Activity (Control)

NO INTERVENTION

Participants maintain habitual daily activities with no structured training.

Interventions

Supervised sessions focused on functional, multi-joint movements adapted for older adults; emphasis on safety and progressive overload.

Adapted CrossFit Program

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Community-dwelling older adults able to walk independently without assistance.
  • Cognitive function preserved, defined as a score of 26 points or higher on the Mini-Mental State Examination.
  • Absence of severe health conditions that would interfere with participation in exercise training.

You may not qualify if:

  • Presence of active neuromuscular or musculoskeletal disorders that prevent safe exercise participation.
  • Severe cardiovascular, pulmonary, or metabolic disease that contraindicates moderate-intensity exercise.
  • Any other medical or psychological condition that, in the opinion of the investigators, would make participation unsafe or unreliable.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Jaén

Jaén, JAEN, 23009, Spain

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 22, 2025

First Posted

September 30, 2025

Study Start

February 1, 2025

Primary Completion

June 30, 2025

Study Completion

July 1, 2025

Last Updated

September 30, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

De-identified individual data will be available on reasonable request to the corresponding author after publication and for 5 years, in accordance with data protection policies.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
From 6 months after publication
Access Criteria
Requests with a brief proposal; data use agreement required.
More information

Locations