Effects of Mental Practice and Therapeutic Exercise in Mild Smokers

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)

Study Overview

• Status: Completed
• Conditions: Smokers
• Intervention / Treatment: Behavioral: Therapeutic exercise program plus action observation training; Behavioral: Therapeutic exercise program plus sham action observation training

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46010
    • Universitat de València

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

Those who presented:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Action observation plus exercise; Therapeutic exercise plus action observation training	Behavioral: Therapeutic exercise program plus action observation training; 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.
Sham Comparator: Sham observation plus exercise; Therapeutic exercise plus sham action observation training	Behavioral: Therapeutic exercise program plus sham action observation training; Participants make a sham observation before each session. Subsequently, they perform the therapeutic exercise program of 6 sessions in a period of 2 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)	Before the start of the program, in the middle of the program (1 week) and at the end of the program (2 weeks)

Collaborators and Investigators

• Sponsor: University of Valencia

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2023
• Primary Completion (Actual): April 28, 2024
• Study Completion (Actual): July 1, 2024

Study Registration Dates

• First Submitted: October 6, 2023
• First Submitted That Met QC Criteria: November 7, 2023
• First Posted (Actual): November 9, 2023

Study Record Updates

• Last Update Posted (Actual): March 28, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: smokers; therapeutic exercise; mental practice; respiratory function
• Other Study ID Numbers: 2023-FIS-2731776-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No