Effect of Functional Inspiratory Muscle Training in Patients with Multiple Sclerosis
NCT06672770, Not applicable, Not yet recruiting, Selcuk University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Effect of Functional Inspiratory Muscle Training in Patients with Multiple Sclerosis | ClinicalTrials.gov |
| NCT number | NCT06672770 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 63 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Selcuk University | ClinicalTrials.gov |
| Conditions | Core Muscles, Functional Inspiratory Muscle Training, Multiple Sclerosis, Respiratory Muscles | ClinicalTrials.gov |
| Interventions | Functional Inspiratory Muscle Training, Basic Inspiratory Muscle Training | ClinicalTrials.gov |
| First posted | 2024-11-04 | ClinicalTrials.gov |
| Last updated | 2024-11-04 | ClinicalTrials.gov |
Registered outcomes 18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Inspiratory Respiratory Muscle Strength | 8 weeks | Participants' respiratory muscle strength will be measured with a portable device (Micro Medical Micro RPM, UK) that can measure intraoral pressure electronically, which is a non-invasive method, and the results will be recorded as maximal inspiratory pressure (MIP). The participant's nose will be closed with a valve while they are maximally expiratory in a sitting position, and a maximal inspiration will be requested for 1 - 3 seconds to complete the MIP measurement and the measurements will be recorded. The highest of the three best results, with no more than 10% difference between them, among at least five measurements will be recorded as the final data. | ClinicalTrials.gov |
| Primary | Expiratory Respiratory Muscle Strength | 8 weeks | Participants' respiratory muscle strength will be measured with a portable device (Micro Medical Micro RPM, UK) that can electronically measure intraoral pressure, which is a non-invasive method, and the results will be recorded as maximal expiratory pressure (MEP). MEP measurement will be completed by closing the nose of the participant who is maximally inspiratory in a sitting position with a valve and asking the participant to exhale maximally for 1-3 seconds, and the measurements will be recorded. The highest of the three best results, with no more than 10% difference between them, among at least five measurements will be recorded as the final data. | ClinicalTrials.gov |
| Primary | Respiratory Function (FEV₁) | 8 weeks | Respiratory functions will be assessed with a portable spirometer with the patient in a sitting position according to the criteria set by the American Thoracic Society and the European Respiratory Society. Spirometry measures multiple parameters during a single test. Participants will be asked to take a single forced breath during normal breathing and then exhale a single forced breath, measuring the forced expiratory volume (FEV₁) in the first second of the lung function test. | ClinicalTrials.gov |
| Primary | Respiratory Function (FVC) | 8 weeks | Participants will be asked to take a single forced breath during normal breathing and then exhale a single forced breath, measuring the forced vital capacity (FVC) of the lung function test. | ClinicalTrials.gov |
| Primary | Respiratory Function (FEV₁/FVC) | 8 weeks | Participants will be asked to take a single forced breath during normal breathing and then exhale a single forced breath, measuring the forced expiratory volume in the first second/forced vital capacity ratio (FEV₁/FVC) of the lung function test. | ClinicalTrials.gov |
| Primary | Respiratory Function (PEF) | 8 weeks | Participants will be asked to take a single forced breath during normal breathing and then exhale a single forced breath, measuring peak expiratory flow rate (PEF) of the lung function test. | ClinicalTrials.gov |
| Primary | Respiratory Function (FEF%25-75) | 8 weeks | Participants will be asked to take a single forced breath during normal breathing and then exhale a single forced breath, measuring forced expiratory midflow rate (FEF%25-75) of the lung function test. | ClinicalTrials.gov |
| Primary | Respiratory Function (VC) | 8 weeks | Respiratory function will be assessed with a portable spirometer with the patient in a sitting position according to the criteria determined by the American Thoracic Society and the European Respiratory Society. The test will be repeated three times. Participants will be asked to inhale deeply and exhale deeply for sixty seconds. As a result of three consecutive tests, the highest and percentages of the expected vital capacity (VC) values of respiratory function will be obtained. | ClinicalTrials.gov |
| Primary | Paced Auditory Serial Addition Test (PASAT) | 8 weeks | PASAT test is a test used to evaluate attention, processing speed and working memory. Within the scope of the test, participants are required to add numbers given at a certain speed and add each new number to the previous number. | ClinicalTrials.gov |
| Primary | Symbol Digit Modalities Test (SDMT) | 8 weeks | This test is a test that measures cognitive processing speed. Patients match the numbers corresponding to certain symbols by finding their equivalents as much as possible. | ClinicalTrials.gov |
| Primary | Stroop Test | 8 weeks | The Stroop test will be used to measure executive functions and attention control. Participants are asked to name the ink colors of words written with color names. For example, when the word "green" is written in blue ink, participants should say "blue." | ClinicalTrials.gov |
| Primary | Walking | 8 weeks | Participants' walking will be evaluated with a 10-meter walking test. Participants will be positioned at the starting line in a pre-measured 10-meter area and the time will be started when the participant steps on the starting line. If the participant uses a walking aid, they will be allowed to walk with it and the measurement will be made twice. The time will end when the participant crosses the finish line at the end of the 10 meters and the best value will be recorded in m/sec. | ClinicalTrials.gov |
| Primary | Balance | 8 weeks | Balance will be evaluated with a timed up and go test. The participant, sitting on the chair, with feet flat on the floor and arms resting on the chair rest, will be asked to get up from the chair, walk the previously measured three-meter area at a safe and normal pace, turn, walk back, and sit back on the chair. The time will be measured in seconds for three repetitions and the best result will be recorded. | ClinicalTrials.gov |
| Primary | Functional Exercise Capacity | 8 weeks | The functional exercise capacity of the participants will be measured with a 6-minute walk test. The 6-minute walk test is used to determine the maximum distance the participant can walk in six minutes. It is used to measure walking fatigue and walking endurance. Before starting the test, the participants will be informed that they will have to walk as fast as possible without running in a thirty-meter corridor for six minutes and that they can rest by taking a break if they wish, but their rest periods will not be added to the six minutes. The participants will be encouraged once per minute with standard expressions during walking. The distance the participant has walked at the end of the six minutes will be recorded in meters. | ClinicalTrials.gov |
| Primary | Physical Activity | 8 weeks | Participants' physical activity status will be assessed with the International Physical Activity Questionnaire short form (SF-IPAQ). The survey consists of seven questions. The duration and frequency of each activity performed in the last week are questioned in the survey. The MET values defined for walking (3.3 METs), moderate-intensity physical activity (4.0 METs) and vigorous-intensity physical activity (8.0 METs) will be multiplied by duration (minutes) and frequency (days) to reach physical activity score values (MET-min/week). | ClinicalTrials.gov |
| Primary | Quality of Life | 8 weeks | The participants' quality of life will be assessed with the Multiple Sclerosis International Quality of Life Questionnaire, a MS-specific assessment scale. The scale consists of nine subgroups; Daily Living Activities, Psychological Status, Findings, Relationships with Friends, Family Relations, Emotional and Sexual Life, Acceptance of the Disease, Coping with the Disease and Relationships with Medical Personnel. Each question in this scale, consisting of a total of 31 questions, is scored between 0-4 as "Never, Never" (0 points), "Rarely, A Little" (1 point), "Sometimes, A Little" (2 points), "Frequently, A Lot" (3 points), "Always, A Lot" (4 points). In the evaluation, the total score is calculated and the actual score is obtained by dividing by 1.24 for linear transformation, since the maximum score that can be obtained from the scale is 124. Low scores indicate high quality of life. | ClinicalTrials.gov |
| Primary | Core Muscles (Pelvic Bridge Test) | 8 weeks | The pelvic bridge test and modified plank test will be used to assess the stabilization of the core muscles. For the pelvic bridge test, participants will be asked to lie on their backs with their knees flexed and their arms extended at their sides, and then they will be instructed to straighten their trunk by lifting their pelvic region. The time they can maintain this position will be recorded. | ClinicalTrials.gov |
| Primary | Core Muscles (Modified Plank Test) | 8 weeks | The pelvic bridge test and modified plank test will be used to assess the stabilization of the core muscles. In the modified plank test, participants will be shown a series of movements and the time they maintain these positions will be recorded and measured. | 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 23
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 10412550 | BACKGROUND | PubMed |
| 12091180 | BACKGROUND | PubMed |
| 15271124 | BACKGROUND | PubMed |
| 15571060 | BACKGROUND | PubMed |
| 15893685 | BACKGROUND | PubMed |
| 16055882 | BACKGROUND | PubMed |
| 16264058 | BACKGROUND | PubMed |
| 16434648 | BACKGROUND | PubMed |
| 16630375 | BACKGROUND | PubMed |
| 17444504 | BACKGROUND | PubMed |
| 17942521 | BACKGROUND | PubMed |
| 18296944 | BACKGROUND | PubMed |
| 18303108 | BACKGROUND | PubMed |
| 20398859 | BACKGROUND | PubMed |
| 21058606 | BACKGROUND | PubMed |
| 23850461 | BACKGROUND | PubMed |
| 25724874 | BACKGROUND | PubMed |
| 26639011 | BACKGROUND | PubMed |
| 29358317 | BACKGROUND | PubMed |
| 30467372 | BACKGROUND | PubMed |
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 3
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 |
|---|---|---|
| Paced Visual Serial Addition Test | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Symbol Coding | Primary 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)