- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07437521
Effects of Assessment and Verbal Feedback on Physical Function and Exercise Adherence in Healthy Older Adults
The Effect of Periodic Assessment and Verbal Feedback on Physical Function, Adherence and Self-perceived Competence in Healthy Adults Aged ≥65: a Pilot Randomized Controlled Trial
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).
Study Overview
Status
Intervention / Treatment
Detailed Description
This study is a pilot RCT that included healthy adults aged 65 years and older, with active registration in the Senior Citizens' Centers (KAPI) of the Municipality of Nikaia-Agios Ioannis Rentis, Athens, Greece. Ethical approval for the study was obtained from the Ethics Committee of the University of West Attica (Protocol No. 107620/24-10-2025) before study initiation.
Prior to participation, all eligible candidates received written information about the study and their voluntary participation, and provided written informed consent in accordance with the Declaration of Helsinki. Candidates who confirmed their willingness to participate were subsequently screened for eligibility based on the inclusion and exclusion criteria and they were allocated into two groups using a randomized procedure. Group allocation was known to the participants; however, the physiotherapist delivering the exercise program was blind to group assignment (intervention or control).
All participants followed the same structured and supervised exercise program, delivered by a municipal physiotherapist, with a duration of 12 weeks and a frequency of two sessions per week and a 48-hour interval between sessions. Each session lasted approximately 50 minutes and included warm-up, main exercise, and cool-down components. Exercise intensity was moderate, individually adapted based on perceived exertion, and progressively increased over time.
At baseline assessment, all participants completed the Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2) to assess exercise motivation, the Activities-specific Balance Confidence (ABC) Scale to evaluate self-reported balance confidence during activities of daily living, and the Self-Efficacy for Exercise (SEE) Scale. Physical performance and functional mobility were assessed using the Short Physical Performance Battery (SPPB) and the Timed Up and Go (TUG) test. Exercise adherence was monitored throughout the intervention period by means of attendance records completed at each session.
Participants allocated to the intervention group underwent three additional assessments at weeks 3, 6, and 9 using the TUG test and the ABC Scale, conducted under conditions consistent with baseline assessments by the same evaluator. Following each assessment, participants in the intervention group received brief, individualized, and encouraging verbal feedback regarding their performance and progress. The control group did not receive additional periodic assessments or feedback.
After completion of the 12-week intervention, all participants underwent post-intervention assessments identical to baseline, conducted under comparable conditions to ensure data consistency and reliability.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Athens, Greece, 18233
- Senior Citizens' Clubs (KAPI) of the Municipality of Nikaia - Agios Ioannis Rentis
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Assessment & verbal feedback
Participants received periodic assessments and individualized verbal feedback.
|
Participants underwent 3 periodic assessments and received individualized verbal feedback on their progress.
Other Names:
|
|
No Intervention: Control
Participants did not receive periodic assessments and individualized verbal feedback.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Short Physical Performance Battery (SPPB)
Time Frame: From enrollment to the end of the exercise program at 12 weeks.
|
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)
Time Frame: From enrollment to the end of the exercise program at 12 weeks.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Activities-specific Balance Confidence Scale (ABC)
Time Frame: From enrollment, at weeks 3, 6, 9 and at the end of 12 weeks.
|
(a) a score below 50% corresponds to a low level of functional status, (b) a score between 50% and 80% indicates a moderate level, and (c) a score above 80% reflects a high level of confidence in maintaining balance.
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From enrollment, at weeks 3, 6, 9 and at the end of 12 weeks.
|
|
Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2)
Time Frame: From enrollment to the end of the exercise program at 12 weeks.
|
It consists of five subscales: amotivation, external regulation, introjected regulation, identified regulation, and intrinsic motivation.
Higher scores are associated with greater motivation to participate in exercise.
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From enrollment to the end of the exercise program at 12 weeks.
|
|
Exercise adherence
Time Frame: At the end of the exercise program at 12 weeks.
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A weekly attendance record was maintained in order to monitor the exercise participation.
Satisfactory adherence to the exercise program was defined as a total participation rate of ≥80%.
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At the end of the exercise program at 12 weeks.
|
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Timed Up and Go test (TUG)
Time Frame: From enrollment, at weeks 3, 6, 9 and at the end of 12 weeks.
|
Test completion time of less than 10 seconds is considered normal for healthy older adults, whereas values greater than 13,5 seconds have been associated with an increased risk of falls.
|
From enrollment, at weeks 3, 6, 9 and at the end of 12 weeks.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Vasiliki Sakellari, Professor, University of West Attica
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 107620/24-10-2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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