Trial · NCT07648498
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 32
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Physical Activity Enjoyment Scale Score | Baseline and Week 4. | Acceptability of the intervention will be assessed quantitatively using the change in Physical Activity Enjoyment Scale (PACES) score from baseline to post-intervention. The PACES is a self-report questionnaire consisting of 18 items rated on a 7-point Likert scale. Responses are summed to generate a total score ranging from 18 to 126, with higher positive change scores indicating greater enjoyment of physical activity and higher acceptability of the intervention. |
| Primary | Qualitative Acceptability (Interviews) of the Intervention | Week 4. | Acceptability of the intervention will be explored through semi-structured, one-on-one interviews conducted following post-intervention testing. Interviews will assess participants' experiences with the program, including perceived acceptability, enjoyment, burden, time commitment, ease of integration into existing routines, facilitators and barriers to adherence, sustainability, perceived effects, and overall impressions of the handgrip device. Interviews will be audio-recorded, transcribed, and analyzed using inductive thematic analysis to identify key themes related to participant experience and acceptability. |
| Primary | Recruitment Rate | Recruitment period, anticipated up to 3 months. | Feasibility of recruitment will be assessed as the number of participants enrolled in the study over the recruitment period. Recruitment rate will be calculated as the average number of participants enrolled per month (participants/month). |
| Primary | Intervention Adherence (Session Attendance) | Week 4. | Adherence will be assessed as the proportion of prescribed intervention sessions attended by each participant. Session attendance (%) will be calculated as the number of attended sessions divided by the total number of prescribed sessions (8 sessions over 4 weeks), multiplied by 100. Higher percentages indicate greater adherence. |
| Primary | High Attendance Rate | Week 4 | High attendance rate will be defined as attending ≥75% of prescribed intervention sessions. This outcome will be calculated as the proportion of participants who meet or exceed this threshold, expressed as a percentage (%). |
| Primary | Retention Rate | Week 4. | Retention will be assessed as the proportion of enrolled participants who complete the post-intervention assessment. Retention rate will be calculated as the number of participants who complete follow-up testing divided by the number enrolled, multiplied by 100 to yield a percentage (%). |
| Primary | Protocol Fidelity | Week 4. | Protocol fidelity will be assessed as the proportion of attended sessions in which participants complete the full isometric handgrip exercise protocol as prescribed (i.e., all contractions at the target intensity and duration). Fidelity will be calculated as the number of sessions completed according to protocol divided by the number of attended sessions, multiplied by 100 to yield a percentage (%). Higher values indicate greater fidelity. |
| Primary | Adverse Events (Safety) | Over the testing and intervention period, 4 weeks. | Safety will be assessed by recording the number and type of adverse events occurring during or immediately following baseline testing, intervention sessions, or post-intervention testing. The total number of adverse events will be reported as a count. |
| Primary | Participant Reported Safety (Qualitative) | Week 4. | Participants' perceptions of safety and comfort during the intervention will be explored through semi-structured, one-on-one interviews conducted following post-intervention testing. Responses will be analyzed qualitatively using thematic analysis. |
| Primary | Reasons for Withdrawal | Over the intervention period, 4 weeks. | Reasons for withdrawal will be recorded for all participants who discontinue participation prior to completing the study. Reasons will be documented based on participant report at the time of withdrawal. Reported reasons will be reviewed and grouped into categories as appropriate during analysis. The number of withdrawals in each category will be reported as a count (number of participants), and the distribution of reasons may also be summarized descriptively. |
| Primary | Assessment Feasibility | Week 4. | Feasibility of administering the cognitive and physiological assessment battery will be evaluated based on participant perceptions of the testing sessions, explored through semi-structured post-intervention interviews. |
| Secondary | Change in Trail Making Test Part A Completion Time | Baseline and Week 4. | Participants are asked to connect numbered circles in sequential order (1-2-3, etc.) as quickly as possible. This test assesses processing speed. Performance is measured as the total time in seconds (s) required to complete the task. Lower completion time indicates better performance. |
| Secondary | Change in Trail Making Test Part B Completion Time | Baseline and Week 4. | Participants are asked to alternate between numbers and letters in sequence (e.g., 1-A-2-B, etc.) while connecting circles as quickly as possible. This test assesses executive function and cognitive flexibility. Performance is measured as the total time in seconds (s) required to complete the task. Lower completion time indicates better performance. |
| Secondary | Change in Montreal Cognitive Assessment Score | Baseline and Week 4. | The Montreal Cognitive Assessment (MoCA) is a brief screening tool used to assess global cognitive function across multiple domains, including memory, attention, language, and executive function. It consists of a series of tasks, with scores ranging from 0 to 30, where higher scores indicate better cognitive function. |
| Secondary | Change in the Digit Symbol Substitution Test Score | Baseline and Week 4. | Participants are given a key pairing numbers with symbols and are asked to match as many symbols to the corresponding numbers as possible within a fixed time period. This test assesses processing speed. Performance is measured as the number of correct responses completed within the time limit, reported as a count (number of correct responses), with higher scores indicating greater performance. |
| Secondary | Change in Short Self-Regulation Questionnaire Score | Baseline and Week 4. | The Short Self-Regulation Questionnaire is a self-report measure that assesses an individual's ability to regulate their thoughts, emotions, and behaviors. Participants respond to a series of statements using a 5-point Likert scale, and responses are summed to generate a total score. Scores range from 31-155, with higher scores indicating greater self-regulation. |
| Secondary | Change in Stroop Color and Word Test Interference Score | Baseline and Week 4. | Interference score will be calculated using the paper-and-pencil Stroop Color and Word Test (Golden version). The interference score will be calculated using the Golden method, where predicted Color-Word performance is derived as (W × C) / (W + C), and interference is calculated as the difference between actual and predicted Color-Word scores (CW - \[(W × C) / (W + C)\]). Higher scores indicate better inhibitory control. |
| Secondary | Change in Stroop Word Score | Baseline and Week 4. | Number of correct responses in the Stroop Word condition completed within 45 seconds using the paper-and-pencil Stroop Color and Word Test (Golden version). Higher scores indicate better performance. |
| Secondary | Change in Stroop Color Score | Baseline and Week 4. | Number of correct responses in the Stroop Color condition completed within 45 seconds using the paper-and-pencil Stroop Color and Word Test (Golden version). Higher scores indicate better performance. |
| Secondary | Change in Stroop Color-Word Score | Baseline and Week 4. | Number of correct responses in the Stroop Color-Word condition completed within 45 seconds using the paper-and-pencil Stroop Color and Word Test (Golden version). Higher scores indicate better performance. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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