NCT07437521

Brief Summary

The goal of this pilot Randomized Controlled Trial (RCT) was to investigate whether the provision of periodic assessment and verbal feedback during an exercise program has an effect on adherence, physical function and self-perceived competence in healthy community-dwelling older adults, aged ≥65 years. An exercise program with periodic assessment and individualized verbal feedback was compared to the same exercise program delivered without individualized assessment and feedback to determine differences in adherence, functional performance, and self-perceived ability in community-dwelling older adults. Participants:

  • participated in a structured exercise program for 12 weeks (2times/week)
  • underwent periodic assessments and received verbal feedback (intervention group only).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 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

October 25, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2026

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2026

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
Last Updated

March 4, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

February 14, 2026

Last Update Submit

March 1, 2026

Conditions

Keywords

older adultsexerciseverbal feedbackperiodic assessmentadherencephysical functionself-perceived competence

Outcome Measures

Primary Outcomes (2)

  • Short Physical Performance Battery (SPPB)

    Each test is scored on a 4-point scale, and the total score is calculated as the sum of the individual test scores, ranging from 0 to 12. Higher scores indicate better physical fitness and functional ability.

    From enrollment to the end of the exercise program at 12 weeks.

  • Exercise Self-Efficacy Scale (ESE)

    Each item of the scale is rated on an 11-point scale, ranging from 0 (no confidence at all) to 10 (complete confidence).

    From enrollment to the end of the exercise program at 12 weeks.

Secondary Outcomes (4)

  • Timed Up and Go test (TUG)

    From enrollment, at weeks 3, 6, 9 and at the end of 12 weeks.

  • Activities-specific Balance Confidence Scale (ABC)

    From enrollment, at weeks 3, 6, 9 and at the end of 12 weeks.

  • Exercise adherence

    At the end of the exercise program at 12 weeks.

  • Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2)

    From enrollment to the end of the exercise program at 12 weeks.

Study Arms (2)

Assessment & verbal feedback

EXPERIMENTAL

Participants received periodic assessments and individualized verbal feedback.

Behavioral: Periodic assessment and individualized verbal feedback

Control

NO INTERVENTION

Participants did not receive periodic assessments and individualized verbal feedback.

Interventions

Participants underwent 3 periodic assessments and received individualized verbal feedback on their progress.

Also known as: periodic assessment, verbal feedback
Assessment & verbal feedback

Eligibility Criteria

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

You may qualify if:

  • Healthy adults of any gender, aged 65 years and older
  • Actively registered at the Senior Citizens' Clubs (KAPI) of the Municipality of Nikaia - Agios Ioannis Rentis, Athens, Greece
  • Required to live independently in their own homes
  • Able to stand, move, and perform activities of daily living without assistance

You may not qualify if:

  • Explicit recommendation from the participant's physician not to participate in an exercise program
  • Serious underlying medical conditions, neurological disorders, or any contraindications to physical exercise (e.g., severe heart disease or uncontrolled hypertension)
  • Significant limitations in mobility or functional capacity
  • Inability to complete the Short Physical Performance Battery tests
  • Hypotension or orthostatic hypotension
  • Psychiatric disorders
  • Cognitive impairment (Mini-Mental State Examination score \<24/30)
  • Visual or hearing impairments limiting the ability to participate in exercise
  • Use of medications restricting the ability to engage in physical activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Senior Citizens' Clubs (KAPI) of the Municipality of Nikaia - Agios Ioannis Rentis

Athens, 18233, Greece

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Vasiliki Sakellari, Professor

    University of West Attica

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

February 14, 2026

First Posted

February 27, 2026

Study Start

October 25, 2025

Primary Completion

February 2, 2026

Study Completion

February 4, 2026

Last Updated

March 4, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

All collected IPD.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Beginning 3 months after publication and ending 3 years after publication.
Access Criteria
Upon reasonable request.

Locations