Flexibility and Strength Training in Asthma

NCT02370004 | Completed Results

• 1 other identifier: 2014p000994
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is proof of concept and to establish the feasibility of performing a study of resistive flexibility and strength training (RFST) in patients with asthma, with the future goal of designing a larger randomized trial to test the hypothesis that RFST leads to greater improvement in asthma symptoms, pulmonary function tests, range of motion and connective tissue mobility compared with a control conventional physical therapy intervention.

Conditions

Asthma

Keywords

Asthma; RFST; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Outcome Measures

Primary Outcomes (1)

• Forced Expiratory Volume at One Second - FEV1 % Predicted

  Forced expiratory volume - an assessment of pulmonary function

  Change from baseline to end of study - 5 weeks

Secondary Outcomes (3)

• Asthma Control Test (ACT)

  Change from baseline to end of study - 5 weeks

• Range of Motion Measurement- Circumference

  Change from baseline to end of study - 5 weeks

• Range of Motion Measurements- Degree of Motion

  Change from baseline to end of study- 5 weeks

Study Arms (1)

Resistive Flexibility and Strength Training

EXPERIMENTAL

Each subject will undergo Resistive Flexibility and Strength Training (RFST) with a trained practitioner.

Procedure: Resistive Flexibility and Strength Training

Interventions

Resistive Flexibility and Strength Training PROCEDURE

RFST is a physical therapy technique where a certified practitioner extends or flexes a joint with the subject actively resists the motion applied by the practitioner. During the RFST treatment a subject will lie on a massage table while the practitioner holds the subject's arm or leg and flexes or extends the limb, instructing the patient to resist the flexion or extension produced by the practitioner. The process is repeated a number of times for each muscle while varying joint positions.

Resistive Flexibility and Strength Training

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients, age ≥ 18 yrs
• Physician-diagnosed asthma
• Currently taking asthma medications
• Asthma Control Questionnaire (ACQ) score \>1.25

You may not qualify if:

• Smoking history of ≥10 pack years
• Pregnancy or lactation or subjects planning to get pregnant during the course of the trial
• Major medical problems prohibiting study participation, i.e. presence of chronic or active lung disease other than asthma or history of unstable significant medical illness other than asthma or concurrent medical problems that would place the participant at increased risk as determined by the study physician

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dr. Elliot Israel
• Organization: Brigham and Women's Hospital

eisrael@partners.org

6177328201

Study Officials

• Elliot Israel, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Asthma Research Center

Study Record Dates

• First Submitted: September 2, 2014
• First Posted: February 24, 2015
• Study Start: July 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: June 4, 2020
• Results First Posted: June 4, 2020

Record last verified: 2020-05

Locations

US (1)