Cost-effectiveness and Efficacy of Different Physical Exercise Interventions (ExerMOT4Health)
NCT06425679, Not applicable, Unknown, University of Cadiz
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Cost-effectiveness and Efficacy of Different Physical Exercise Interventions (ExerMOT4Health) | ClinicalTrials.gov |
| NCT number | NCT06425679 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 120 participants, actual | ClinicalTrials.gov |
| Lead sponsor | University of Cadiz | ClinicalTrials.gov |
| Conditions | Physical Inactivity, Healthy Aging, Older Adult | ClinicalTrials.gov |
| Interventions | Supervised synchronous online exercise intervention without motivational strategies, Supervised synchronous online exercise intervention with motivational strategies, Supervised face to face exercise intervention without motivational strategies, Supervised face to face exercise intervention with motivational strategies | ClinicalTrials.gov |
| First posted | 2024-05-22 | ClinicalTrials.gov |
| Last updated | 2024-05-22 | ClinicalTrials.gov |
Registered outcomes 37
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Neuropsychological Performance | Baseline (week 0), post-intervention (week 25), and follow-up (week 48) | The Trail-Making Test Part A and B will be administered. Part A is based on number sequencing, participants link numbers from 1 to 25 in ascending order. Part B focuses on alternating numbers and letters in ascending order. The completion time will be registered in seconds (the lower duration, the best performance). | ClinicalTrials.gov |
| Primary | Depression | Baseline (week 0), post-intervention (week 25), and follow-up (week 48) | The short 15-item version of the Yesavage Geriatric Depression Scale will be used. This is a questionnaire used to screen for depression in older people. This scale consists of 15 items with a yes/no answer pattern, being the minimum score 0 and the maximum 15. The cut-off point for Depression is 5 or more. | ClinicalTrials.gov |
| Primary | Lower-body muscular function | Baseline (week 0), post-intervention (week 25), and follow-up (week 48) | Lower limb muscle performance will be assessed using the 30-seconds Chair Sit to Stand (30-s CST) test. The number of standing up in 30 seconds will be counted. A higher score, better performance. | ClinicalTrials.gov |
| Secondary | Upper-body muscular function | Baseline (week 0), post-intervention (week 25), and follow-up (week 48) | Grip strength will be measured with a digital hand-held dynamometer on both arms (Takei TKK5401, Tokyo, Japan). The test was performed in both standing and sitting positions, in both cases with the arm fully extended. A higher score, better performance. | ClinicalTrials.gov |
| Secondary | Maximum walking speed (3, 4, 6 and 10-m) | Baseline (week 0), post-intervention (week 25), and follow-up (week 48). | Maximum gait speed will be evaluated by measuring the time used to walk 3, 4, 6 and 10 meters linear distance at maximum pace without running. Gait speed is calculated by dividing the distance into registered walking time. A higher speed (or lower registered time) better performance. | ClinicalTrials.gov |
| Secondary | Usual walking speed (3, 6 and 10-m) | Baseline (week 0), post-intervention (week 25), and follow-up (week 48). | Usual gait speed will be evaluated by measuring the time used to walk 3, 6 and 10 meters linear distance at usual pace. Gait speed is calculated by dividing the distance into registered walking time. A higher speed (or lower registered time) better performance. | ClinicalTrials.gov |
| Secondary | Short Physical Performance Battery (SPPB) | Baseline (week 0), post-intervention (week 25), and follow-up (week 48) | It consists of three parts: the ability to stand with feet together in side-to-side, semi-tandem, and tandem positions (balance), 4-meters walk test (speed), and 5 times sit-to-stand (muscle power). Each part is scored from 0 to 4, with a total SPPB score of 12 points, a higher score, better performance. | ClinicalTrials.gov |
| Secondary | Senior Fitness Test (SFT) | Baseline (week 0), post-intervention (week 25), and follow-up (week 48). | SFT battery includes 30-second chair stand test (lower-body strength), 30-second arm curl test (upper-body strength), 6-minute walk test (aerobic endurance), Chair sit-and-reach test (lower-body flexibility), Back scratch test (upper-body flexibility) and 8-foot up-and-go test (agility and dynamic balance). | ClinicalTrials.gov |
| Secondary | Resting blood pressure | Baseline (week 0), post-intervention (week 25), and follow-up (week 48) | Systolic and diastolic blood pressure will be assessed in a seated position, twice, 2 minutes apart, after 5 minutes at rest, using a digital upper arm blood pressure monitor (OMRON M6, Spain). Blood pressure will be assessed at the level of the right atrium, with the participant's back supported and uncrossed legs with both feet on the floor. | ClinicalTrials.gov |
| Secondary | Resting heart rate | Baseline (week 0), post-intervention (week 25), and follow-up (week 48) | Heart rate will be assessed in a seated position twice, 2 minutes apart, after 5 minutes at rest, units will be bpm (beats per minute), using a digital upper arm blood pressure monitor (OMRON M6, Spain). | ClinicalTrials.gov |
| Secondary | Anthropometry | Baseline (week 0), post-intervention (week 25), and follow-up (week 48). | Height will be measured with a stadiometer (Seca 213, Hamburg, Germany). Body mass will be measured using a body composition analyzer (InBody 770, Biospace, California, USA). The participant will be barefoot and wearing as minimally clothed as possible. Body mass index will be calculated as body mass (kg) divided by height (m) squared (kg·m-2). | ClinicalTrials.gov |
| Secondary | Body perimeters | Baseline (week 0), post-intervention (week 25), and follow-up (week 48). | Waist and hip perimeters will be measured in upright position in accordance with the ISAK guidelines with a circumference tape (Lukfin, W606PM) following the standardized protocol, as well as calf perimeter in a sitting position. | ClinicalTrials.gov |
| Secondary | Body composition | Baseline (week 0), post-intervention (week 25), and follow-up (week 48) | Body Composition will be measured using a body composition analyzer (InBody 770, Biospace, California, USA), following the standardized protocol. Fat mass (kg and %), fat free mass (kg and %) and skeletal muscle mass (kg and %) will be obtained. | ClinicalTrials.gov |
| Secondary | Health-related quality of life | Baseline (week 0), post-intervention (week 25), and follow-up (week 48) | The EuroQol-5D questionnaire will be used for assessing the health-related quality of live of the participants, including five dimensions and a visual analogue scale. The 5 dimensions included in the descriptive system are (1) mobility, (2) self-care, (3) usual activities, (4) pain/discomfort, and (5) anxiety/depression. Responses will be coded according to the three-level scale for each dimension. A utility value will be assigned to each combination of responses. This index provides a quantitative measure of each individual's health-related quality of life, where 0 represents the worst possible health and 1 represents the best possible health.The EQ-VAS scale consists of asking participants to indicate their current health status from 0 ("worst imaginable health status") to 100 ("best imaginable health status"). | ClinicalTrials.gov |
| Secondary | Cognitive Performance- The Montreal Cognitive Assessment | Baseline (week 0), post-intervention (week 25), and follow-up (week 48). | The Montreal Cognitive Assessment (MoCA) assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The total possible score ranged from 0 to 30, and the highest score indicates better performance. | ClinicalTrials.gov |
| Secondary | Cognitive Performance-The Stroop Color and Word Test (SCWT) | Baseline (week 0), post-intervention (week 25), and follow-up (week 48). | The Stroop Color and Word Test (SCWT) is divided into three conditions, the first condition consists of reading color names printed in black ink, in the second condition the participant will read colors printed in an "X", and the third condition consists of naming the ink color instead of reading the word. All conditions contain 100 words, and time is limited to 45 seconds for each condition. The total number of correct words for each condition will be recorded, indicating that the higher the number of correct words, the better the performance. | ClinicalTrials.gov |
| Secondary | Cognitive Performance- Digit Span test of the Wechsler Adult Intelligence Scale III | Baseline (week 0), post-intervention (week 25), and follow-up (week 48). | Digit Span test of the Wechsler Adult Intelligence Scale III (WAIS III). Participants will be asked to recall a list of numbers in the order given (forward or backwards). The test is finished when for the same item, the participant fails two attempts. A total number of correct answers will be registered for each condition, ranging from 0 to 30, with the highest scores being the best performance. | ClinicalTrials.gov |
| Secondary | Cognitive Performance-Clock Drawing Test (CDT). | Baseline (week 0), post-intervention (week 25), and follow-up (week 48). | The test consists of drawing a clock with a given time (11:10). The total score is the sum of the scores given to dial, numbers and clock faces, ranging from 0 to 10 with the highest scores being the best performance. | ClinicalTrials.gov |
| Secondary | Cognitive Performance- Digit Symbol Substitution Test | Baseline (week 0), post-intervention (week 25), and follow-up (week 48). | Digit Symbol Substitution Test. The participant will fill in a series of coded symbols for 90 and 120 seconds. The total number of responses as well as errors are recorded. In this test, the higher the score, the better the performance. | ClinicalTrials.gov |
| Secondary | Anxiety | Baseline (week 0), post-intervention (week 25), and follow-up (week 48) | The Zung Anxiety Self-Assessment Scale will be used to assess anxiety symptoms. It consists of 20 items with a 4-point response scale ranging from 1 (not at all or hardly ever) to 4 (most or all of the time), obtaining a maximum score of 80. The higher the score, the higher anxiety. | 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 5
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 |
|---|---|---|
| Trail Making Test A | Primary outcome | ConductCognition |
| Clock Drawing Task | Secondary outcome | ConductCognition |
| Digit Span Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Symbol Coding | 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)