Trial · NCT07913893
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in 1-Minute Sit-to-Stand Test Performance | Baseline (Week 0), Week 6, and Week 12 | Lower-limb functional performance was assessed using the 1-minute sit-to-stand test (1-min STS). Participants were instructed to complete as many full sit-to-stand repetitions as possible in 60 seconds using a standardized armless chair. The outcome was the number of correctly completed repetitions. Higher values indicate better functional performance. Changes were assessed across three time points. |
| Primary | Change in Dominant-Hand Handgrip Strength | Baseline (Week 0), Week 6, and Week 12 | Handgrip strength was measured using a Jamar hydraulic hand dynamometer. Three maximal voluntary contraction trials were performed with the dominant hand, with rest intervals between attempts. The highest recorded value was used for analysis and expressed in kilograms (kg). Higher values indicate greater handgrip strength. Changes were assessed across three time points. |
| Secondary | Change in Pain Intensity (Numeric Rating Scale) | Baseline (Week 0), Week 6, and Week 12 | Pain intensity measured using an 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity. Changes from baseline were planned to be assessed at weeks 6 and 12. |
| Secondary | Change in Fibromyalgia Impact (FIQR) | Baseline (Week 0), Week 6, and Week 12 | Fibromyalgia impact assessed using the Revised Fibromyalgia Impact Questionnaire (FIQR). The total score ranges from 0 to 100 and reflects physical function, overall impact, and symptoms. Higher scores indicate greater disease impact and worse health status. |
| Secondary | Change in Health-Related Quality of Life (SF-36) | Baseline (Week 0), Week 6, and Week 12 | Health-related quality of life assessed using the 36-Item Short Form Health Survey (SF-36). Eight health domains are scored from 0 to 100. Higher scores indicate better perceived health status. Changes in domain scores were planned to be assessed over time. |
| Secondary | Change in Sleep Quality (Pittsburgh Sleep Quality Index) | Baseline (Week 0), Week 6, and Week 12 | Sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI). The global score ranges from 0 to 21, calculated from seven components of sleep quality. Higher scores indicate poorer sleep quality. |
| Secondary | Change in Multidimensional Fatigue (MFI-20) | Baseline (Week 0), Week 6, and Week 12 | Fatigue assessed using the 20-item Multidimensional Fatigue Inventory (MFI-20), which measures general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced motivation. Each subscale ranges from 4 to 20, with higher scores indicating greater fatigue or impairment. |
| Secondary | Change in Physical Activity Level (IPAQ-SF) | Baseline (Week 0), Week 6, and Week 12 | Self-reported physical activity assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF). Walking, moderate-intensity, and vigorous-intensity activities during the preceding seven days are used to classify physical activity as low, moderate, or high according to IPAQ scoring guidelines. |
| Secondary | Change in Pain Catastrophizing (PCS) | Baseline (Week 0), Week 6, and Week 12 | Pain-related catastrophic thinking assessed using the Pain Catastrophizing Scale (PCS). The total score ranges from 0 to 52 and includes rumination, magnification, and helplessness components. Higher scores indicate greater pain catastrophizing. |
| Secondary | Change in Fear of Movement (TSK-11) | Baseline (Week 0), Week 6, and Week 12 | Fear of movement and reinjury assessed using the 11-item Tampa Scale for Kinesiophobia (TSK-11). Total scores range from 11 to 44. Higher scores indicate greater fear of movement. |
| Secondary | Change in Anxiety Symptoms (HADS-A) | Baseline (Week 0), Week 6, and Week 12 | Anxiety symptoms assessed using the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). The seven-item subscale has a total score ranging from 0 to 21. Higher scores indicate more severe anxiety symptoms. |
| Secondary | Change in Depressive Symptoms (HADS-D) | Baseline (Week 0), Week 6, and Week 12 | Depressive symptoms assessed using the depression subscale of the Hospital Anxiety and Depression Scale (HADS-D). The seven-item subscale has a total score ranging from 0 to 21. Higher scores indicate more severe depressive symptoms. |
| Secondary | Change in Perceived Stress (PSS) | Baseline (Week 0), Week 6, and Week 12 | Perceived stress assessed using the Perceived Stress Scale (PSS), which measures the extent to which situations in daily life are perceived as stressful. Higher total scores indicate greater perceived stress. The scoring range must be confirmed against the version of the questionnaire used in this study. |
| Other | Program Attendance and Adherence Rate | Weekly during the 12-week intervention (Weeks 1-12); final adherence calculated at Week 12. | Program adherence was assessed by recording the number of weekly group sessions attended by each participant out of 12 scheduled sessions. Attendance was expressed as the total number of sessions attended (0-12) and as a percentage of the 12 scheduled sessions. Higher percentages indicate greater program attendance. |
| Other | Perceived Exertion During Exercise (Borg CR10 Scale) | Each weekly exercise session during the 12-week intervention (Weeks 1-12). | Perceived exertion was monitored during supervised exercise sessions using the modified Borg Category-Ratio 10 scale (CR10), ranging from 0 (no exertion) to 10 (maximal exertion). Ratings were recorded during or at the end of the exercise component to assess exercise intensity, monitor tolerance, and guide individual exercise adaptations. Higher scores indicate greater perceived exertion. |
| Other | Post-Exercise Pain Intensity During Weekly Sessions (NRS) | Immediately after exercise at each weekly session during the 12-week intervention (Weeks 1-12). | Pain intensity was monitored using an 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Pain ratings were collected immediately after the exercise component of each weekly session to assess symptom responses and exercise tolerance. Higher scores indicate greater pain intensity. Ratings were used to guide exercise modifications and safety monitoring throughout the program. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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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