Identifying Mediators of Exercise-induced Tumor Microenvironment Remodeling to Enhance Primary Chemotherapy Response (IMPROVE-Ovarian)
NCT07932106, Not applicable, Not yet recruiting, University of Pittsburgh
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Identifying Mediators of Exercise-induced Tumor Microenvironment Remodeling to Enhance Primary Chemotherapy Response (IMPROVE-Ovarian) | ClinicalTrials.gov |
| NCT number | NCT07932106 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 20 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University of Pittsburgh | ClinicalTrials.gov |
| Conditions | High Grade Serous Ovarian, Ovarian Adenocarcinoma, Ovarian Cancer, Serous Adenocarcinoma of Ovary, Ovarian Cancer (OvCa) | ClinicalTrials.gov |
| Interventions | Exercise, Usual Care | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Acceptability of Intervention | From enrollment until study completion, approximately 3-4 months | Acceptability will be defined as ≥60% of women approached for study participation will agree to participate and opt in to the exercise intervention. | ClinicalTrials.gov |
| Primary | Adherence to intervention | From enrollment until study completion, approximately 3-4 months | Exercise adherence will be calculated as the proportion of completed exercise sessions over the number of prescribed sessions. | ClinicalTrials.gov |
| Primary | Feasibility of Intervention | From enrollment until study completion, approximately 3-4 months | Feasibility will be defined as ≥60% adherence to the prescribed exercise intervention. | ClinicalTrials.gov |
| Secondary | Six-minute walk test (6MWT) | Baseline, midway through NACT (approximately 6 weeks after baseline), and after completion of NACT (approximately 3-4 months after baseline). | Cardiorespiratory fitness will be measured using the six minute walk test. The 6MWT is an objective evaluation of functional exercise capacity. Its results are highly correlated with those of the 12-minute walk test from which it was derived and with those of cycle ergometer or treadmill-based exercise tests. | ClinicalTrials.gov |
| Secondary | 30-second chair stand test (30CST) | Baseline, midway through NACT (approximately 6 weeks after baseline), and after completion of NACT (approximately 3-4 months after baseline). | Lower body strength will be evaluated using the 30 second chair stand test. The participant is seated in the middle of the chair, back straight, feet approximately shoulder width apart and placed on the floor. Arms are crossed at the wrists and held against the chest. At the signal "go," the participant rises to a full body stand and then returns to the initial seated position. The participant is encouraged to complete as many full stands as possible within 30 seconds. | ClinicalTrials.gov |
| Secondary | 2-Minute Step Test | Baseline, midway through NACT (approximately 6 weeks after baseline), and after completion of NACT (approximately 3-4 months after baseline). | Cardiorespiratory fitness will be measured with the 2-minute step test. Participants will be marching in place for 2 minutes and are encouraged to use a chair for balance or do the assessment seated if standing is too difficult. They should be lifting their legs about 6 inches off the ground, as if they were stepping onto a curb from the road. The tester will count the number of times the participant raises their right leg off the ground. | ClinicalTrials.gov |
| Secondary | Timed-Up-and-Go (TUG) test | Baseline, midway through NACT (approximately 6 weeks after baseline), and after completion of NACT (approximately 3-4 months after baseline). | The TUG evaluates lower body strength, balance, and agility. The patient sits in a chair and on the command "go", the patient rises from the chair, walks 3 meters at a self-selected pace, turns around an obstacle, walks back to the chair and sits down. Test results may also be quantified assessing the time (seconds) needed to complete the assessment. | ClinicalTrials.gov |
| Secondary | Handgrip assessment | Baseline, midway through NACT (approximately 6 weeks after baseline), and after completion of NACT (approximately 3-4 months after baseline). | Maximum capacity to squeeze with each hand may be assessed using a hand grip dynamometer. Each hand may be assessed three times. | ClinicalTrials.gov |
| Secondary | Short Physical Performance Battery (SPPB) | Baseline, midway through NACT (approximately 6 weeks after baseline), and after completion of NACT (approximately 3-4 months after baseline). | The SPPB is a short battery of performance tests of lower extremity functioning. The tests measure gait speed, standing balance, and lower extremity strength and power. To test gait speed, patients are instructed to walk an 4-meter walking course at their usual pace with assistive devices if needed. Three progressively more challenging positions are used to test balance (bipedal \[feet next to each other\], semi-tandem \[one foot slightly in front of the other\], and full tandem \[one foot in front of the other\]). To test lower extremity strength, patients are asked to stand up and sit down five times as quickly as possible and are timed from the initial sitting position to the final standing position at the end of the fifth stand. The scores for the overall assessment is the sum of the scores of each of the subtests. The scores for the individual subtests on their own are not research validated data points. Min = 0; Max = 12; higher score = better performance | ClinicalTrials.gov |
| Secondary | SARC-F Sarcopenia scale | Baseline, midway through NACT (approximately 6 weeks after baseline), and after completion of NACT (approximately 3-4 months after baseline). | The SARC-F questionnaire is a short 5-item battery containing observational assessments that is a rapid diagnostic test for sarcopenia. There are 5 SARC-F components: Strength, Assistance with walking, Rise from a chair, Climb Stairs, and Falls. Min = 0; Max = 10; higher score = higher risk for sarcopenia | ClinicalTrials.gov |
| Secondary | Edmonton Frail Scale (EDS) | Baseline, midway through NACT (approximately 6 weeks after baseline), and after completion of NACT (approximately 3-4 months after baseline). | The Edmonton Frail Scale is a reliable measure for frailty that is easy to use, captures the multidimensional aspects of fatigue, and presents the level of frailty along a continuum so that change over time can be captured. The semi-structured interview collects data across 9 frailty domains: cognition, general health status, functional independence, social support, medication use, nutrition, mood, continence, and functional performance. Scores fall within one of 5 categories (not frail, vulnerable, mild frailty, moderate frailty, severe frailty) and range from 0 (not frail) to 17 (severe frailty). Min = 0; Max = 17; higher score = higher frailty risk | ClinicalTrials.gov |
| Secondary | Fried Frailty Index for physical frailty (FFI) | Baseline, midway through NACT (approximately 6 weeks after baseline), and after completion of NACT (approximately 3-4 months after baseline). | The Fried Frailty Index is a short battery of physical performance tests and observational assessments that evaluate phenotypic frailty. The index evaluates weight loss in the past year, weakness via grip strength, self-reported fatigue, gait speed, and self-reported physical activity levels. The score for the index is the sum of the scores of each of the measured items listed above. The scores for the individual items on their own are not research validated data points. Min = 0; Max = 5; higher score = higher frailty risk | ClinicalTrials.gov |
| Secondary | EORTC QLQ-C30 Quality of Life (QoL) | Baseline, midway through NACT (approximately 6 weeks after baseline), and after completion of NACT (approximately 3-4 months after baseline). | QoL may be assessed with the validated 30-item self-assessment questionnaire of the European Organization for Research and Treatment of Cancer (EORTC QLQ-C30, version 3.0). It includes five multi- item functional scales (physical, role, emotional, cognitive, and social function), three multi-item symptom scales (fatigue, pain, nausea/vomiting), and six single items assessing further symptoms (dyspnea, insomnia, appetite loss, constipation, diarrhea) and financial difficulties. Scores are derived according to the EORTC scoring manual. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems. | ClinicalTrials.gov |
| Secondary | EORTC QLQ-OV28 Ovarian Cancer-related QOL | Baseline, midway through NACT (approximately 6 weeks after baseline), and after completion of NACT (approximately 3-4 months after baseline). | Ovarian cancer specific QoL may be further assessed with the validated 28-item self-assessment questionnaire of the European Organization for Research and Treatment of Cancer (EORTC QLQ-OV28). It includes seven multi-item symptom and functional scales (abdominal/gastrointestinal symptoms, peripheral neuropathy, other chemotherapy side effects, hormonal/menopausal symptoms, body image, attitude to disease treatment, and sexual functioning). Scores are derived according to the EORTC scoring manual. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems. | ClinicalTrials.gov |
| Secondary | Multidimensional Fatigue Inventory | Baseline, midway through NACT (approximately 6 weeks after baseline), and after completion of NACT (approximately 3-4 months after baseline). | Fatigue may be assessed with the Multidimensional Fatigue Inventory (MFI) which is a 20-item, multidimensional self-assessment questionnaire. It covers five different dimensions of fatigue (general, physical, reduced activity, reduced motivation, and mental). Scores are derived by summing the answers (five-stage scale) of the appropriate items. Min = 20; Max = 100; higher score = less fatigue | ClinicalTrials.gov |
| Secondary | Godin Leisure Time Exercise | Baseline, midway through NACT (approximately 6 weeks after baseline), and after completion of NACT (approximately 3-4 months after baseline). | Physical activity patterns during a patient's leisure time may be assessed using the Godin Leisure Time Exercise questionnaire. The questionnaire asks patients to recall, during a seven-day period, the frequency to which they participated in strenuous, moderate, and mild exercise. The Godin questionnaire is short and easy to complete. Min = 0; Max = none; higher score = more activity | ClinicalTrials.gov |
| Secondary | PROMIS Cognitive Function- Short Form | Baseline, midway through NACT (approximately 6 weeks after baseline), and after completion of NACT (approximately 3-4 months after baseline). | Cognitive function may be measured by the 8-item PROMIS questionnaire. The questionnaire assesses patient-perceived cognitive deficits including mental acuity, concentration, verbal and nonverbal memory, verbal fluency, and perceived changes in these cognitive functions. Min = 8; Max = 40; higher score = better cognitive function | ClinicalTrials.gov |
| Secondary | PG-SGA Nutrition Assessment- Short Form | Baseline, midway through NACT (approximately 6 weeks after baseline), and after completion of NACT (approximately 3-4 months after baseline). | The Patient-Generated Subjective Global Assessment (PG-SGA) is a patient-reported instrument for assessment of nutrition status in patients with cancer. The PG-SGA short form is completed by patients and screens for nutritional risk and deficit. Min = 0, Max = 36; higher score = worse nutrition status | ClinicalTrials.gov |
| Secondary | Brief Pain Inventory (BPI) | Baseline, midway through NACT (approximately 6 weeks after baseline), and after completion of NACT (approximately 3-4 months after baseline). | The BPI is a 9-item, self-assessment questionnaire that has been largely validated. The BPI measures both the intensity of pain (sensory dimension) and interference of pain in the participant's life (reactive dimension). It also asks the participant about pain relief, pain quality, and participant perception of the cause of pain. Pain Severity: Min = 0; Max = 40; higher score = higher pain severity Pain Interference: Min = 0; Max = 7; higher score = higher pain interference | ClinicalTrials.gov |
| Secondary | Feasibility of Intervention Measure (FIM) | After completion of NACT (at approximately 3-4 months) | The FIM is a 4-item measure used to measure and compare participant feasibility of an intervention. This will only be completed by those in the EX group. Min = 4; Max = 20; higher score = higher intervention feasibility | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Verbal Fluency | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)