Effects of Mental Practice and Therapeutic Exercise in Mild Smokers

NCT06123598 | Completed

• 1 other identifier: 2023-FIS-2731776-2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

smokers; therapeutic exercise; mental practice; respiratory function

Outcome Measures

Primary Outcomes (1)

• Respiratory strength

  Maximal respiratory pressures (in H2O centimeters)

  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

  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

  Before the start of the program, in the middle of the program (1 week) and at the end of the program (2 weeks)

Study Arms (2)

Action observation plus exercise

EXPERIMENTAL

Therapeutic exercise plus action observation training

Behavioral: Therapeutic exercise program plus action observation training

Sham observation plus exercise

SHAM COMPARATOR

Therapeutic exercise plus sham action observation training

Behavioral: Therapeutic exercise program plus sham action observation training

Interventions

Therapeutic exercise program plus action observation training BEHAVIORAL

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.

Action observation plus exercise

Therapeutic exercise program plus sham action observation training BEHAVIORAL

Participants make a sham observation before each session. Subsequently, they perform the therapeutic exercise program of 6 sessions in a period of 2 weeks.

Sham observation plus exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 years old
• Had a pack per year index of \<5 (mild smoking index).

You may not qualify if:

• Those who presented:
• a respiratory pathology,
• cardiac, systematic, or metabolic disease,
• history of recent surgery,
• vertebral fracture,
• or osteoarticular disorders of the spine area.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Universitat de Valencia

Valencia, Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be assigned to one of two study groups by the person conducting the intervention. All participants receive mental practice (real or sham) and the exercise program. The evaluators are unaware of the assignment at all times.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: November 9, 2023
• Study Start: October 30, 2023
• Primary Completion: April 28, 2024
• Study Completion: July 1, 2024
• Last Updated: March 28, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)