Exercise and Nutrition for Healthy AgeiNg
NCT03649698, Not applicable, Unknown, Universitaire Ziekenhuizen KU Leuven
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Exercise and Nutrition for Healthy AgeiNg | ClinicalTrials.gov |
| NCT number | NCT03649698 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 180 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Universitaire Ziekenhuizen KU Leuven | ClinicalTrials.gov |
| Conditions | Sarcopenia | ClinicalTrials.gov |
| Interventions | Home-based training program, High-quality protein supplement, Omega-3 fatty acid, Placebo protein powder, Placebo omega-3 | ClinicalTrials.gov |
| First posted | 2018-08-28 | ClinicalTrials.gov |
| Last updated | 2024-06-28 | ClinicalTrials.gov |
Registered outcomes 46
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in physical functioning | Measured at baseline, week 12 and week 24. | Change in SPPB score | ClinicalTrials.gov |
| Primary | Percentage of participants with change in physical functioning | Measured at baseline, week 12 and week 24. | the percentage of participants with more than 1 or 1 point increase in SPPB score. | ClinicalTrials.gov |
| Secondary | Change in muscle mass (after intervention-baseline) | Measured at screening, week 12 and week 24 with DXA or when screening is 6 weeks prior to baseline, DXA will also be performed at baseline. At screening, baseline, week 12 and week 24 with BIA. | Appendicular lean mass will be measured with a whole-body DXA scan and by BIA. | ClinicalTrials.gov |
| Secondary | Change in muscle strength (after intervention-baseline) | Hand grip measured at screening, baseline, week 12 and week 24. Biodex measured at baseline, week 12 and week 24. | Muscle strength of the knee-extensor, knee-flexor and hip abductors will be measured by Biodex and hand grip strength with dynamometer. | ClinicalTrials.gov |
| Secondary | Compliance to the exercise intervention, subjective | baseline until week 12 | Compliance to the Otago program will be assessed by measure of: \- The number of Otago sessions the participant performed divided by the number of Otago sessions the participants needed to perform. Likewise, this will be calculated for the walking program and for the integral exercise intervention. | ClinicalTrials.gov |
| Secondary | Compliance to the exercise intervention, objective | baseline until week 12 | Compliance to the Otago program will be assessed by measure of: \- Monitor and diary: Length of exercise session (time). Pattern recognition of exercise groups by algorithm development | ClinicalTrials.gov |
| Secondary | Compliance to the exercise intervention, subjective, detailed | baseline until week 12 | Compliance to the Otago program will be assessed by measure of: \- Diary: the reported intensity of the strength exercises | ClinicalTrials.gov |
| Secondary | Compliance to the protein supplementation, objective | Urine samples at baseline, week 1, 2, 4, 6, 8, 10, 12, 24. | Compliance to protein supplementation: \- The number of nutritional intakes the participant did divided by the number of intakes of nutritional supplement the participant was prescribed. | ClinicalTrials.gov |
| Secondary | Compliance to the protein supplementation, subjective | Urine samples at baseline, week 1, 2, 4, 6, 8, 10, 12, 24. | Compliance to protein supplementation: \- Count and weight returned powder boxes | ClinicalTrials.gov |
| Secondary | Compliance to the protein supplementation objective | Urine samples at baseline, week 1, 2, 4, 6, 8, 10, 12, 24. | Compliance to protein supplementation: \- N content in 8 24h urine samples by the Dumas method (28) to estimate rise in protein intake and Creatinine index to estimate the completion of the urine samples (29, 30) | ClinicalTrials.gov |
| Secondary | Compliance to the omega-3 supplementation, subjective | baseline, week 12 and week 24. | Compliance to omega-3 supplement \- Count returned capsules and placebo tablets | ClinicalTrials.gov |
| Secondary | Compliance to the omega-3 supplementation, objective | baseline, week 12 and week 24. | Compliance to omega-3 supplement \- Compliance to the omega- 3 supplement is assessed by counting the number of capsules during each study visit and by analysis of red blood cell (RBC) membrane fatty acid profile | ClinicalTrials.gov |
| Secondary | Functional status: frailty | baseline, week 12 and 24 | \- Change in physical frailty stage defined by Fried et al (frail (3-5/5), prefrail (1-2/5), robust (0/5)) | ClinicalTrials.gov |
| Secondary | Functional status: activities of daily living | baseline, week 12 and 24 | Change in activity of daily living (ADL) :Barthel-index | ClinicalTrials.gov |
| Secondary | Functional status: balance | baseline, week 12 and 24 | Change in balance (Mini-BESTest) | ClinicalTrials.gov |
| Secondary | Functional status: change in physical activity | baseline, week 12 and 24 | Change in PA by the MoveMonitor+ (MM+) (method under development in our research group) | ClinicalTrials.gov |
| Secondary | Functional status: health-related quality of life | baseline, week 12 and 24 | \- Change in health-related quality of life, according to Short Form Health Survey (SF-36) questionnaire | ClinicalTrials.gov |
| Secondary | Functional status: falls | baseline, week 12 and 24 | \- Number of falls and the circumstances, identified using weekly fall calendars + Falls Efficacy Scale International (FES-I) | ClinicalTrials.gov |
| Secondary | Cognitive status: immediate and delayed memory, attention, language and visuospatial skills | baseline, week 12 and 24 | \- The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS): immediate and delayed memory, attention, language and visuospatial skills; | ClinicalTrials.gov |
| Secondary | Cognitive status: inhibition | baseline, week 12 and 24 | Stroop test (inhibition) | 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 4
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|---|---|
| Stroop Color-Word Test | 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)