Immediate Effects of Mental Practice and Therapeutic Exercise in Mild Smokers

Immediate 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 session 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: Recruiting
• Conditions: Smokers
• Intervention / Treatment: Behavioral: Theapeutic exercise plus action observation training; Behavioral: Therapeutic exercise plus sham observation training

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

Contacts and Locations

• Study Contact: Name: Francisco Martínez-Arnau, PhD; Phone Number: 51227 0034963983853; Email: francisco.m.martinez@uv.es

Study Locations

• Spain
  • Valencia, Spain
    • Recruiting
    • Universitat de València
    • Contact: Francisco Martínez-Arnau, PhD; Phone Number: 51227 0034963983853; Email: francisco.m.martinez@uv.es

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: Theapeutic exercise plus action observation training; Participants make an observation of actions related to the training they are going to perform. Subsequently, they perform the therapeutic exercise session.
Sham Comparator: Sham observation plus exercise; Therapeutic exercise plus sham action observation training	Behavioral: Therapeutic exercise plus sham observation training; Participants make a sham observation. Subsequently, they perform the therapeutic exercise session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory strength	Maximal respiratory pressures (in H2O centimeters)	Preintervention and inmediately after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory function parameters	Spirometric parameters (in liters/second)	Preintervention and inmediately after the intervention
Physical function	5 times sit-to-stand test (in seconds)	Preintervention and inmediately after the intervention

Collaborators and Investigators

• Sponsor: University of Valencia

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: October 6, 2023
• First Submitted That Met QC Criteria: October 24, 2023
• First Posted (Actual): October 31, 2023

Study Record Updates

• Last Update Posted (Actual): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: smokers; therapeutic exercise; mental practice; respiratory function
• Other Study ID Numbers: 2023-FIS-2731776-1

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