Older Adults (65 Years and Older)NCT07437521
Effects of Assessment and Verbal Feedback on Physical Function and Exercise Adherence in Healthy Older Adults
A study testing Periodic assessment and individualized verbal feedback in people with Older Adults (65 Years and Older) and Healthy Older Adults, run by University of West Attica at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Older Adults (65 Years and Older), Healthy Older Adults, Community Dwelling Older Adults
- What is being tested?
- Periodic assessment and individualized verbal feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteGreece
- Study dates
- 25 Oct 2025to 4 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Greece1 site
Senior Citizens' Clubs (KAPI) of the Municipality of Nikaia - Agios Ioannis Rentis
Athens, 18233
About this study
Official title: 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.
Read more
Participants:
- participated in a structured exercise program for 12 weeks (2times/week)
- underwent periodic assessments and received verbal feedback (intervention group only).
Read the 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.
- Being tested
- Periodic assessment and individualized verbal feedback
- Keywords
- older adults, exercise, verbal feedback, periodic assessment, adherence, physical function, self-perceived competence
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodic assessment and individualized verbal feedbackBehavioural
Also called periodic assessment, verbal feedback
Participants underwent 3 periodic assessments and received individualized verbal feedback on their progress.
| Study group | Role | What they receive |
|---|---|---|
| Assessment & verbal feedback | Experimental | Participants received periodic assessments and individualized verbal feedback. Receives: Behavioral: Periodic assessment and individualized verbal feedback |
| Control | No intervention | Participants did not receive periodic assessments and individualized verbal feedback. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: From enrollment to the end of the exercise program at 12 weeks.
Secondary outcomes (4)
Timed Up and Go test (TUG)
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.
Measured: From enrollment, at weeks 3, 6, 9 and at the end of 12 weeks.
Activities-specific Balance Confidence Scale (ABC)
(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.
Measured: From enrollment, at weeks 3, 6, 9 and at the end of 12 weeks.
Exercise adherence
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%.
Measured: At the end of the exercise program at 12 weeks.
Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2)
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.
Measured: From enrollment to the end of the exercise program at 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start25 Oct 2025
- Primary completion2 Feb 2026
- Study completion4 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older Adults (65 Years and Older)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of West Attica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danai Paleta, University of West Attica
- Investigators
- Vasiliki Sakellari, Professor, Study chair, University of West Attica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07437521
- Sponsor's protocol ID
- 107620/24-10-2025
- Status last verified
- Feb 2026
- First submitted
- 14 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD.
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07437521
- Acronym / sponsor ID
- 107620/24-10-2025
- Keywords
- older adults, exercise, verbal feedback, periodic assessment, adherence, physical function, self-perceived competence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of West AtticaUniversity, hospital or other
- Study start
- 25 Oct 2025 (actual)
- Primary completion
- 2 Feb 2026 (actual)
- Study completion
- 4 Feb 2026 (actual)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Assessment & verbal feedback | Experimental | Behavioral: Periodic assessment and individualized verbal feedbackParticipants received periodic assessments and individualized verbal feedback. |
| Control | No intervention | –Participants did not receive periodic assessments and individualized verbal feedback. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Periodic assessment and individualized verbal feedbackAlso: periodic assessment, verbal feedbackParticipants underwent 3 periodic assessments and received individualized verbal feedback on their progress. | Behavioural | Assessment & verbal feedback |
Primary outcome
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.
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).
4 secondary outcomes
Timed Up and Go test (TUG)
Time frame: From enrollment, at weeks 3, 6, 9 and at the end of 12 weeks.
Activities-specific Balance Confidence Scale (ABC)
Time frame: From enrollment, at weeks 3, 6, 9 and at the end of 12 weeks.
Exercise adherence
Time frame: At the end of the exercise program at 12 weeks.
Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2)
Time frame: From enrollment to the end of the exercise program at 12 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: Yes. All collected IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vasiliki Sakellari, Professor study chair
University of West Attica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Periodic assessment and individualized verbal feedback in people with Older Adults (65 Years and Older) and Healthy Older Adults, run by University of West Attica at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Physical Performance Battery (SPPB) (time frame: From enrollment to the end of the exercise program at 12 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.