Effects of Mental Practice and Therapeutic Exercise in Mild Smokers

Sponsor

University of Valencia (Other)

Overall Status

Recruiting

CT.gov ID

NCT06123598

Collaborator

(none)

Enrollment

Location

Arms

13.1

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Smokers	Behavioral: Therapeutic exercise program plus action observation training Behavioral: Therapeutic exercise program plus sham action observation training	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

Effects of Mental Practice and Therapeutic Exercise in Mild Smokers: a Randomized Controlled Trial

Anticipated Study Start Date :

Oct 30, 2023

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Respiratory strength [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)

Secondary Outcome Measures

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)]
Forced expiratory volume in the first second FEV1 (in liters/second) and forced expiratory volume FVC (In liters/second) obtained from a spirometry
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)]
5 times sit-to-stand test (in seconds)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitat de Valencia	Valencia		Spain	46010

Sponsors and Collaborators

University of Valencia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Francisco Martínez Arnau, Professor, University of Valencia

ClinicalTrials.gov Identifier:

NCT06123598

Other Study ID Numbers:

2023-FIS-2731776-2

First Posted:

Nov 9, 2023

Last Update Posted:

Nov 9, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Francisco Martínez Arnau, Professor, University of Valencia

Study Results

No Results Posted as of Nov 9, 2023