The Effects of 'Functional' Inspiratory Muscle Training

NCT04460261 | Completed DMC

• 1 other identifier: 20201987
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study was designed as a prospective and experimental study. Geriatric individuals (age ≥ 65 years) with COPD and non-COPD were included in the study. Training program was identical for both groups and consisted of 4 weeks of foundation IMT followed by 4 weeks of functional IMT. Respiratory muscle strength, symptoms, exercise capacity, balance, postural control, physical activity and quality of life were evaluated.

Conditions

Exercise

Keywords

chronic obstructive pulmonary disease; functional inspiratory muscle training; geriatric individuals

Outcome Measures

Primary Outcomes (6)

• Inspiratory muscle strength

  Inspiratory muscle strength (MIP) was measured using a hand-held mouth pressure device (Micro RMP; Micro Medical, Rochester, UK). Three to five acceptable and reproducible maximal manoeuvres (i.e., differences between values \<10%) were performed and the highest value was recorded.

  8 weeks

• Expiratory muscle strength

  Expiratory muscle strength (MEP) was measured using a hand-held mouth pressure device (Micro RMP; Micro Medical, Rochester, UK). Three to five acceptable and reproducible maximal manoeuvres (i.e., differences between values \<10%) were performed and the highest value was recorded.

  8 weeks

• Dyspnea assessment

  The Modified Medical Research Council (mMRC) Dyspnea Scale was used to evaluate dyspnea. Commonly used in the assessment of dyspnea in COPD, mMRC has a five-level scoring system ranging from 0 to 4. A high score indicates an increased sense of dyspnea.

  8 weeks

• Symptoms assessment

  The COPD Assessment Test (CAT) was used to assess symptoms in patients with COPD. It is a reliable test to evaluate the impact of COPD on a patient's health status. It has eight items and the score ranges from 0 to 40. Higher scores indicate increased symptoms.

  8 weeks

• Upper extremity functional exercise capacity assessment

  The 6-Minute Pegboard and Ring Test was used to assess upper extremity functional exercise capacity assessment

  8 weeks

• Lower extremity functional exercise capacity assessment

  The 6-Minute Walking Test (6MWT) was used to assess lower extremity functional exercise capacity assessment.

  8 weeks

Secondary Outcomes (5)

• Balance assessment

  8 weeks

• Static antero-posterior postural stability assessment

  8 weeks

• Static medio-lateral postural stability assessment

  8 weeks

• Physical activity assessment

  8 weeks

• Quality of life assessment

  8 weeks

Study Arms (2)

COPD Group

EXPERIMENTAL

Patients with COPD

Other: Functional Inspiratory Muscle Training

Non-COPD Group

EXPERIMENTAL

Non-COPD

Other: Functional Inspiratory Muscle Training

Interventions

Functional Inspiratory Muscle Training OTHER

Both groups were trained 3 days a week under the supervision of a physiotherapist and other days of the week without a supervisor. The treatment program consisted of 4 weeks of foundation IMT followed by 4 weeks of functional IMT. Foundation IMT was applied during the first 4 weeks of training. The participants were asked to sit in a comfortable upright position. Following the foundation IMT, all participants underwent four weeks of functional IMT. Initially, all participants were taught diaphragmatic breathing and activating abdominal wall musculature. Each training session started with warm-up exercises and ended with cool-down exercises. During the loading phase, core stability, dynamic trunk activation and postural control exercises were applied together with IMT.

COPD Group; Non-COPD Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Diagnosing COPD in accordance with Global initiative for chronic obstructive pulmonary disease (GOLD) guideline criteria
• Being over 65 years old
• Being a stable clinical condition (same medication routine for the past 3 weeks without taking any antibiotics)
• Independent mobilization

You may not qualify if:

• Orthopaedic problems
• Neurological problems
• Cognitive problems

Sponsors & Collaborators

• Ismail OZSOY: lead

MeSH Terms

Conditions

Motor Activity; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Behavior; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ismail ozsoy, PhD

  Selcuk University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: İsmail ÖZSOY

Model Details: This study was designed as a prospective and experimental study. The participants were divided into two groups as geriatric individuals with and without chronic obstructive pulmonary disease (COPD). Both groups were trained 3 days a week under the supervision of a physiotherapist and other days of the week without a supervisor. The treatment program consisted of 4 weeks of foundation IMT followed by 4 weeks of functional IMT.

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: July 7, 2020
• Study Start: February 1, 2016
• Primary Completion: January 15, 2018
• Study Completion: January 15, 2018
• Last Updated: July 8, 2020

Record last verified: 2020-07