Effect and Feasibility of Non-linear Periodized Resistance Training in People With COPD

NCT03518723 | Completed

• 1 other identifier: NLPRT-RCT
• Study Type: interventional
• Target: 57
• Locations: 3 countries
• Sites: 3

Brief Summary

This study aims at improving the knowledge about resistance training for people with COPD. Resistance training is an important part of pulmonary rehabilitation when the goal is to improve muscular endurance and strength. The study will evaluate the effects and the feasibility of two resistance training programs for people with COPD using a parallel group design. One program will include a larger day-to-day variation (i.e. non-linear periodization) and the progression will be guided by ratings of dyspnea, muscle fatigue, and exertion. The other program will follow the established guidelines for resistance training for people with COPD. The programs will be evaluated for effects regarding muscular endurance, strength, intramuscular adaptions, functional preformance, dyspnea, and health related quality of life. The programs will also be evaluated for feasibility regarding the duration of training sessions, attendance rates, adverse events, and participant satisfaction. The hypothesis is that the non-linear periodization group will have superior effects and that feasibility aspects will be similar between groups.

Conditions

Pulmonary Disease; Chronic Obstructive

Keywords

Muscle dysfunction

Outcome Measures

Primary Outcomes (2)

• Change from baseline dynamic maximal endurance at week 9

  Maximal limb muscle endurance measured using resistance training machines or free weights. Reported as the number of repetitions at 45% of the baseline one repetition maximum.

  Baseline and week 9

• Change from baseline dynamic maximal strength at week 9

  Maximal limb muscle strength measured using resistance training machines or free weights. Reported as one repetition max in kg.

  Baseline and week 9

Secondary Outcomes (21)

• Change from baseline static maximal endurance at week 9

  Baseline and week 9

• Change from baseline static maximal strength at week 9

  Baseline and week 9

• Change from baseline unsupported upper limb test (UULEX) at week 9

  Baseline and week 9

• Change from baseline endurance shuttle walk test (ESWT) at week 9

  Baseline and week 9

• Change from baseline 60 seconds sit to stand test (60STS) at week 9

  Baseline and week 9

Study Arms (2)

Non-linear Periodized Resistance Training

EXPERIMENTAL

The objective of the Non-linear Periodized Resistance Training (NLPRT) program is to increase muscle strength as well as muscle endurance. The NLPRT program will over the 8 week intervention period target several different aspects of limb muscle function, by alternating the intensity and volume of the exercises. Progression of exercise is symptom dependent and will be based on Borg CR-10 ratings (dyspnea, muscle fatigue and exertion). All exercises will be performed using exercise equipment that are available at each included center. All sessions are supervised and conducted by local professionals using a group format, with approximately 2-4 participants per group.

Other: Non-linear Periodized Resistance Training

Resistance Training

ACTIVE COMPARATOR

The primary objective of the Resistance training (RT) group is to increase muscular strength. The RT program will be performed in line with current guidelines that are recommended for increasing muscular strength in patients with COPD. Progression of exercise is performance dependent and will be based on the previous 2 sessions. All exercises will be performed using exercise equipment that are available at each included center. All sessions are supervised and conducted by local professionals using a group format, with approximately 2-4 participants per group.

Other: Resistance training

Interventions

Non-linear Periodized Resistance Training OTHER

8 week non-linear periodized resistance training intervention, 3 sessions per week, 60 minutes per session

Non-linear Periodized Resistance Training

Resistance training OTHER

8 week resistance training intervention, 3 sessions per week, 60 minutes per session

Resistance Training

Eligibility Criteria

• Age: 40 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• FEV1/FVC ratio \< 70% postbronchodilator
• FEV1 \<80% of the predicted normal value postbronchodilator

You may not qualify if:

• Clinical evidence of asthma, cardiovascular diseases, and/or neuromuscular diseases that are unstable and/or that may contribute to exercise limitation
• Other contraindications to exercise
• Currently participating in a structured exercise or pulmonary rehabilitation program or been involved in pulmonary rehabilitation in the past 6 months
• Experienced a COPD exacerbation and/or change in medication dosage/frequency in the past 6 weeks

Sponsors & Collaborators

• Umeå University: lead
• Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec: collaborator
• Radboud University Medical Center: collaborator
• Merem Pulmonary Rehabilitation Centre: collaborator

Study Sites (3)

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Québec, Canada

Location

Merem Pulmonary Rehabilitation Centre

Hilversum, Netherlands

Location

Umeå University

Umeå, Sweden

Location

Related Publications (1)

• Frykholm E, Klijn P, Saey D, van Hees HWH, Stal P, Sandstrom T, Sorlin A, Maltais F, Nyberg A. Effect and feasibility of non-linear periodized resistance training in people with COPD: study protocol for a randomized controlled trial. Trials. 2019 Jan 3;20(1):6. doi: 10.1186/s13063-018-3129-y.

  PMID: 30606240 DERIVED

MeSH Terms

Conditions

Lung Diseases

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Respiratory Tract 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

Study Officials

• Andre Nyberg, PhD

  Umeå University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessors will be masked to group allocation. The participants will be given repeated instructions not to reveal their group allocation to the outcome assessors. In case of failure in keeping the outcome assessor masked (i.e, a patient reveals his/her group allocation), a second trained outcome assessor will be available.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, assessor-blind, parallel-group randomized controlled multicenter trial with a pre- and post-intervention design

Study Record Dates

• First Submitted: April 13, 2018
• First Posted: May 8, 2018
• Study Start: April 16, 2018
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); NL (1); SE (1)