NCT07312942

Effects of Controlled Breathing Added to Therapeutic Exercise in Multiple Myeloma

Effects of Adding a Controlled Breathing Protocol to a Therapeutic Exercise Program in Adults With Multiple Myeloma

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Universidad Complutense de Madrid · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A randomized, parallel, double-blind, controlled, multicenter clinical trial with two intervention arms. Two groups of participants will be included, both receiving a therapeutic exercise intervention and an educational session on the importance of proper breathing over a 6-week period. One of the groups will additionally perform a home-based controlled breathing exercise protocol. Pre- and post-intervention assessments (6 weeks) will be conducted, along with a follow-up evaluation 4 weeks after completion of the intervention. The goal is to determine the effectiveness of adding a controlled breathing exercise program to a therapeutic exercise intervention on somatic symptoms in individuals with multiple myeloma

Detailed description

Randomized, parallel, double-blind, controlled clinical trial in which two groups of participants will be included and randomly assigned to one of the two intervention arms: Therapeutic exercise + initial educational session on proper breathing. Therapeutic exercise + initial educational session on proper breathing + home-based controlled breathing exercise protocol. The therapeutic exercise and controlled breathing program will last 6 weeks. During this period, participants will: Perform three weekly sessions of mobility and muscle-strengthening exercises (two on-site and one home-based) for 6 weeks. The on-site sessions will last between 30 and 40 minutes and will take place at the Rehabilitation Department of Hospital 12 de Octubre in Madrid (a total of 12 on-site sessions-two per week). The home-based exercise program will consist of completing, once per week during the 6-week intervention, a structured session that replicates the logic and technique of the on-site program. Walk a minimum of 7,000 steps/day or 50 minutes/day, three days per week. Perform a controlled breathing protocol twice per day at home during the 6-week study period, following the recommendations of the principal investigator. The goal is to integrate slow, gentle, diaphragmatic, nasal breathing into daily life. The variables to be assessed will include: somatic symptom questionnaire, quality of life, sleep quality, fatigue, anxiety and depression symptoms. These variables will be evaluated at baseline, at the end of the 6-week intervention period, and again 4 weeks after completing the intervention.

Conditions

• Multiple Myeloma
• Breathing Techniques
• Breathing Exercises
• Exercise Activity
• Diaphragmatic Breathing

Interventions

Type	Name	Description
OTHER	Controlled breathing exercise protocol + therapeutic exercise + initial education session	In addition to the therapeutic exercise protocol and the educational session on proper breathing, participants will perform a controlled breathing protocol at home twice daily, at least five days per week, throughout the 6-week study period, following the recommendations of the principal investigator. The goal is to integrate slow, gentle, diaphragmatic, nasal breathing into daily life. To promote adherence and ensure correct and consistent execution, participants will have access through the Web-App to two audio files containing guided breathing instructions and visualization exercises. These recordings were specifically developed for this project by a physiotherapist with more than 20 years of experience in respiratory control-based interventions, and were reviewed and approved by the entire research team.
OTHER	Therapeutic exercise + initial education session	In addition to the therapeutic exercise protocol and the educational session on proper breathing, participants will perform: -Three weekly sessions of mobility and muscle-strengthening exercises (two on-site and one home-based) for 6 weeks. The on-site sessions will last between 30 and 40 minutes and will take place at the Rehabilitation Department of Hospital 12 de Octubre in Madrid (a total of 12 on-site sessions-two per week). The home-based exercise program will consist of completing, once per week during the 6-week intervention, a structured session that replicates the logic and technique of the on-site program. A maximum of four absences from the on-site therapeutic exercise program will be allowed, and on those occasions the patient must register via the web application that they completed the prescribed home-based program. -Walk a minimum of 7,000 steps/day or 50 minutes/day, three days per week.

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-05-01
• Completion: 2026-07-01
• First posted: 2025-12-31
• Last updated: 2026-01-20