Trial · NCT07889024
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recruitment rate | Recruitment period (approximately 2 weeks, before randomisation) | Number of participants recruited per month and proportion of the target sample (30-40 participants) recruited within the planned recruitment period. Pre-specified feasibility success criterion: \>=75% of the target sample recruited. Participant flow will be reported in a CONSORT 2025 flow diagram, adapted according to the CONSORT extension for pilot and feasibility trials. |
| Primary | Eligibility and consent rates | Recruitment period (approximately 2 weeks, before randomisation) | Proportion of screened individuals who are eligible, and proportion of eligible individuals who consent to participate and are randomised (%, with 95% confidence intervals). Reasons for ineligibility and refusal will be recorded. |
| Primary | Adherence to the intervention | During the 12-week intervention period | Percentage of scheduled sessions attended (36 exercise sessions and 12 education sessions), per participant and overall, in the intervention group. Pre-specified feasibility success criterion: mean attendance \>=70% of sessions. |
| Primary | Retention | From randomisation to post-intervention assessment (approximately 16 weeks, including a 2-week holiday break) | Proportion of randomised participants who complete the post-intervention assessment, and proportion of dropouts with reasons, in each group. Pre-specified feasibility success criterion: retention \>=80%. |
| Primary | Safety: adverse events | From the start of the intervention to post-intervention assessment (approximately 16 weeks) | Number, type and severity of adverse events, reported as counts and rates per participant and per session, recorded in a structured safety log. Pre-specified success criterion: no serious intervention-related adverse events. |
| Primary | Acceptability: Patient Global Impression of Change (PGIC) | Post-intervention (within 2 weeks after completion of the 12-week intervention) | Participant-rated global impression of change in pain and function attributable to the exercise programme on the 7-point PGIC (Portuguese version; 1 = no change/worse to 7 = a great deal better), complemented by a brief study-specific satisfaction and acceptability questionnaire on the programme components. |
| Secondary | Change in functional mobility: Timed Up and Go (TUG) | Baseline (before randomisation) and post-intervention (within 2 weeks after completion of the 12-week intervention) | Time (seconds) to rise from a chair, walk 3 m, turn 180 degrees, walk back and sit down. Lower values indicate better mobility. |
| Secondary | Change in dual-task mobility: TUG with cognitive task (TUG-DT) and dual-task cost | Baseline (before randomisation) and post-intervention (within 2 weeks after completion of the 12-week intervention) | TUG performed while serially subtracting 3 from a 3-digit number between 300 and 400 (seconds). Dual-task cost (%) = \[(TUG-DT - TUG single task) / TUG single task\] x 100; higher positive values indicate greater cognitive-motor interference. |
| Secondary | Change in lower-limb function: 30-second Chair Stand Test | Baseline (before randomisation) and post-intervention (within 2 weeks after completion of the 12-week intervention) | Number of complete sit-to-stand repetitions in 30 seconds. Higher values indicate better lower-limb function. |
| Secondary | Change in balance: Mini-BESTest | Baseline (before randomisation) and post-intervention (within 2 weeks after completion of the 12-week intervention) | European Portuguese Mini-BESTest, 14 items (anticipatory postural adjustments, reactive postural control, sensory orientation, dynamic gait), total score 0-28. Higher scores indicate better balance. |
| Secondary | Change in knee extensor and flexor muscle strength (isokinetic dynamometry) | Baseline (before randomisation) and post-intervention (within 2 weeks after completion of the 12-week intervention) | Concentric peak torque (Nm), peak torque normalised to body mass (Nm/kg) and flexor/extensor ratio of the knee extensors and flexors at 60 deg/s and 180 deg/s, measured with a HUMAC NORM isokinetic dynamometer (CSMi). |
| Secondary | Change in pain intensity: Brief Pain Inventory - Short Form (BPI-SF) | Baseline (before randomisation) and post-intervention (within 2 weeks after completion of the 12-week intervention) | Portuguese BPI-SF pain severity score: mean of 4 items (worst, least, average and current pain), each rated 0-10. Higher scores indicate more severe pain. |
| Secondary | Change in pain interference: Brief Pain Inventory - Short Form (BPI-SF) | Baseline (before randomisation) and post-intervention (within 2 weeks after completion of the 12-week intervention) | Portuguese BPI-SF pain interference score: mean of 7 items (general activity, mood, walking, normal work, relations with others, sleep, enjoyment of life), each rated 0-10. Higher scores indicate greater interference. |
| Secondary | Change in fear of falling: Short Falls Efficacy Scale-International (Short FES-I) | Baseline (before randomisation) and post-intervention (within 2 weeks after completion of the 12-week intervention) | European Portuguese Short FES-I, 7 items rated 1-4, total score 7-28. Higher scores indicate greater concern about falling. |
| Secondary | Change in kinesiophobia: Tampa Scale for Kinesiophobia (TSK-13) | Baseline (before randomisation) and post-intervention (within 2 weeks after completion of the 12-week intervention) | Portuguese 13-item TSK, each item rated on a 4-point Likert scale, total score 13-52. Higher scores indicate greater fear of movement/(re)injury. |
| Secondary | Change in health-related quality of life: WHOQOL-BREF | Baseline (before randomisation) and post-intervention (within 2 weeks after completion of the 12-week intervention) | European Portuguese WHOQOL-BREF, 26 items rated on 5-point Likert scales; scores for the physical, psychological, social relationships and environment domains and 2 general items. Higher scores indicate better perceived quality of life. |
| Other | Progression level achieved in the dual-task training block | During the 12-week intervention period | Highest progression phase achieved (phase 1, 2 or 3) and modifications made, recorded by instructors on a standardised form for each participant in the intervention group. |
| Other | Participants' perceptions of the education component (qualitative) | Post-intervention (within 2 weeks after completion of the 12-week intervention) | Qualitative data from a brief group interview at the end of the intervention exploring understanding of content, perceived usefulness, applicability of self-management strategies and satisfaction with the pain science and fall-prevention education. Analysed thematically. |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07889024/registered