SmokersNCT06123598
Effects of Mental Practice and Therapeutic Exercise in Mild Smokers
A study testing Therapeutic exercise program plus action observation training in people with Smokers, run by University of Valencia at 1 site in Spain.
Trial summary
The goal of this clinical trial is to learn about the effects who would add mental practice based on action observation to a therapeutic exercise program in young mild smokers. The main question it aims to answer is whether the observation of actions prior to the implementation of a therapeutic exercise program… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smokers
- What is being tested?
- Therapeutic exercise program plus action observation training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 30 Oct 2023to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >18 years old
- Had a pack per year index of <5 (mild smoking index).
Who cannot join
- Those who presented:
- a respiratory pathology,
- cardiac, systematic, or metabolic disease,
- history of recent surgery,
- vertebral fracture,
- or osteoarticular disorders of the spine area.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Mental Practice and Therapeutic Exercise in Mild Smokers: a Randomized Controlled Trial
The goal of this clinical trial is to learn about the effects who would add mental practice based on action observation to a therapeutic exercise program in young mild smokers.
The main question it aims to answer is whether the observation of actions prior to the implementation of a therapeutic exercise program improves the response to it on respiratory, strength and muscle function variables.
Participants will be assigned to one of 2 study groups:
G1) Therapeutic exercise plus action observation training (n=20) G2) Therapeutic exercise plus sham action observation training (n=20)
- Conditions
- Smokers
- Being tested
- Therapeutic exercise program plus action observation training, Therapeutic exercise program plus sham action observation training
- Keywords
- smokers, therapeutic exercise, mental practice, respiratory function
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic exercise program plus action observation trainingBehavioural
Participants make an observation of actions related to the training they are going to perform before each session. Subsequently, they perform the therapeutic exercise program of 6 sessions in a period of 2 weeks.
Therapeutic exercise program plus sham action observation trainingBehavioural
Participants make a sham observation before each session. Subsequently, they perform the therapeutic exercise program of 6 sessions in a period of 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Action observation plus exercise | Experimental | Therapeutic exercise plus action observation training Receives: Behavioral: Therapeutic exercise program plus action observation training |
| Sham observation plus exercise | Sham comparator | Therapeutic exercise plus sham action observation training Receives: Behavioral: Therapeutic exercise program plus sham action observation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory strength
Maximal respiratory pressures (in H2O centimeters)
Measured: Before the start of the program, in the middle of the program (1 week) and at the end of the program (2 weeks)
Secondary outcomes (2)
Spirometric parameters
Forced expiratory volume in the first second FEV1 (in liters/second) and forced expiratory volume FVC (In liters/second) obtained from a spirometry
Measured: Before the start of the program, in the middle of the program (1 week) and at the end of the program (2 weeks)
Physical function
5 times sit-to-stand test (in seconds)
Measured: Before the start of the program, in the middle of the program (1 week) and at the end of the program (2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start30 Oct 2023
- Primary completion28 Apr 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokersStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Martínez Arnau, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123598
- Sponsor's protocol ID
- 2023-FIS-2731776-2
- Status last verified
- May 2024
- First submitted
- 6 Oct 2023
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mental Practice and Therapeutic Exercise in Mild Smokers: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06123598
- Acronym / sponsor ID
- 2023-FIS-2731776-2
- Conditions
- Smokers
- Keywords
- smokers, therapeutic exercise, mental practice, respiratory function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 28 Apr 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn about the effects who would add mental practice based on action observation to a therapeutic exercise program in young mild smokers.
The main question it aims to answer is whether the observation of actions prior to the implementation of a therapeutic exercise program improves the response to it on respiratory, strength and muscle function variables.
Participants will be assigned to one of 2 study groups:
G1) Therapeutic exercise plus action observation training (n=20) G2) Therapeutic exercise plus sham action observation training (n=20)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Action observation plus exercise | Experimental | Behavioral: Therapeutic exercise program plus action observation trainingTherapeutic exercise plus action observation training |
| Sham observation plus exercise | Sham comparator | Behavioral: Therapeutic exercise program plus sham action observation trainingTherapeutic exercise plus sham action observation training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- >18 years old
- Had a pack per year index of <5 (mild smoking index).
Key exclusion criteria (6 listed)
- a respiratory pathology,
- cardiac, systematic, or metabolic disease,
- history of recent surgery,
- vertebral fracture,
- or osteoarticular disorders of the spine area.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic exercise program plus action observation trainingParticipants make an observation of actions related to the training they are going to perform before each session. Subsequently, they perform the therapeutic exercise program of 6 sessions in a period of 2 weeks. | Behavioural | Action observation plus exercise |
| Therapeutic exercise program plus sham action observation trainingParticipants make a sham observation before each session. Subsequently, they perform the therapeutic exercise program of 6 sessions in a period of 2 weeks. | Behavioural | Sham observation plus exercise |
Primary outcome
Respiratory strength
Time frame: Before the start of the program, in the middle of the program (1 week) and at the end of the program (2 weeks)
Maximal respiratory pressures (in H2O centimeters)
2 secondary outcomes
Spirometric parameters
Time frame: Before the start of the program, in the middle of the program (1 week) and at the end of the program (2 weeks)
Physical function
Time frame: Before the start of the program, in the middle of the program (1 week) and at the end of the program (2 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Smokers
Not yet recruiting
Home-Based Respiratory Muscle Training and Aerobic Exercise Programs to Improve Lung Health in Current and Former Cigarette Smokers
Lung Carcinoma
Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
Probiotics, Antibiotics
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
Active, not recruiting
Assessment of HPHC Exposure in Smokers Switching to THS/TP18 With Different Device Variants
Smoking
Active, not recruitingObservational study
EValuating the Safety Of De-escaLated Head and Neck Irradiation in HPV positivE Oropharynx Cancer in Non-smokers/Minimal Smokers
Oropharyngeal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic exercise program plus action observation training in people with Smokers, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory strength (time frame: Before the start of the program, in the middle of the program (1 week) and at the end of the program (2 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.