Effectiveness of a Physical ACtivity Coaching Intervention Using E-Health for COPD Patients in Pulmonary Rehabilitation

NCT06732869 | Recruiting

• 3 other identifiers: ciTechCare_PhD_SFdoi.org/10.54499/2020.06954.BDUIDB/05704/2020
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized controlled trial is to evaluate the efficacy of a physical activity coaching intervention - delivered through an eHealth platform both during and after pulmonary rehabilitation - to enhance physical activity levels and health-related outcomes in patients with Chronic Obstructive Pulmonary Disease (COPD). All participants will attend the pulmonary rehabilitation program for 2 months; the experimental group will receive a physical activity coaching intervention at the end of the 1st month of the rehabilitation program, which will continue for 6 months following the completion of the program. Assessments will be conducted at the beginning, midway, and at the end of the coaching program, as well as 3 months and 6 months after its conclusion.

Conditions

COPD; Physical Activity

Keywords

physical activity; COPD; eHealth; pulmonary rehabilitation

Outcome Measures

Primary Outcomes (1)

• Accelerometry (number of daily steps)

  PA will be objectively measured using the triaxial accelerometer Actigraph GT3X+, already validated in COPD. Patients will be instructed to wear the accelerometer for 7 days on the dominant side of their waist, held by an elastic strap, during waking hours, except for bathing or swimming. A valid day will be defined as a minimum of 8 hours of wearing time, and patients will need to have at least 4 valid days in each moment of data collection. Accelerometer-based data will be then downloaded and analysed using the algorithms of Freedson (1998) with 60-s epoch: daily time (in min) spent in light-intensity PA, moderate, vigorous and a combination of both. The number of steps per day and per week will also be collected, being the main outcome of the study.

  weeks 1, 5, 10 of pulmonary rehabilitation program and 3- and 6-months after its conclusion

Secondary Outcomes (6)

• 6-Minute Walk Test (exercise capacity)

  weeks 1, 5, 10 of pulmonary rehabilitation program and 3- and 6-months after its conclusion

• modified Medical Research Council (Dyspnoea)

  weeks 1, 5, 10 of pulmonary rehabilitation program and 3- and 6-months after its conclusion

• Checklist of Individual Strength (Fatigue)

  weeks 1, 5, 10 of pulmonary rehabilitation program and 3- and 6-months after its conclusion

• COPD Assessment Test (Impact of symptoms on health status)

  weeks 1, 5, 10 of pulmonary rehabilitation program and 3- and 6-months after its conclusion

• MOS Short-Form Health Survey 36 Item v2 (SF-36) (Quality of Life)

  weeks 1, 5, 10 of pulmonary rehabilitation program and 3- and 6-months after its conclusion

Study Arms (2)

Experimental Group - Pulmonary rehabilitation + eHealth physical activity coaching intervention

EXPERIMENTAL

Patients will attend a PR program for 10 weeks and receive an eHealth PA coaching intervention (smartband connected to a mobile application) in the week 5 of PR until months after end of PR.

Behavioral: eHealth physical activity coaching intervention; Behavioral: pulmonary rehabilitation

Control group - pulmonary rehabilitation

OTHER

Patients will attend pulmonary rehabilitation program for 10 weeks.

Behavioral: pulmonary rehabilitation

Interventions

eHealth physical activity coaching intervention BEHAVIORAL

Patients will attend a PR program and in week 5 of PR will receive an eHealth PA coaching intervention until 6 months after end of PR. The PA goals will be prescribed through a phone call and the personalisation of goal prescription will be based on an algorithm considering patient's performance in the previous week, perceived easiness of achieving the previous goal and confidence to change it. If patient does not achieve the goal, reasons, barriers to PA and strategies to overcome them will be identified. Patients will receive a daily notification about their goal achievements, at 6PM every day, giving them the possibility to increase their PA to achieve the goal, if they have not reached it yet. Patients will also receive personalized notifications sent manually by the researcher whenever appropriate. PA goals will be prescribed on a weekly basis.

Experimental Group - Pulmonary rehabilitation + eHealth physical activity coaching intervention

pulmonary rehabilitation BEHAVIORAL

Patients will attend pulmonary rehabilitation program for 10 weeks. Pulmonary rehabilitation is evidence-based multidisciplinary intervention based on thorough patient assessment followed by patient-tailored therapies that include, but are not limited to exercise training, education, self-management intervention aiming at behaviour change, known to improve health status and psychological well-being, reducing dyspnoea and healthcare utilization and hospitalization. In this study, pulmonary rehabilitation programs will have 20 sessions, twice a week, including exercise training (aerobic and strength training), educational sessions about topics as medication, smoking cessation, energy conservation techniques, physical activity, stress and anxiety management, breathing control, inhaled therapy and nutrition; nutritional and psychosocial counselling. Education session about PA importance and recommendations will be also provided in both arms.

Control group - pulmonary rehabilitation; Experimental Group - Pulmonary rehabilitation + eHealth physical activity coaching intervention

Eligibility Criteria

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

You may qualify if:

• age \> 40 years old
• diagnosis of COPD according to GOLD criteria, clinically stable (i.e., with no exacerbations in the previous month)
• being enrolled in a pulmonary rehabilitation program
• having a smartphone with access to the internet
• being able to understand and provide informed consent.

You may not qualify if:

• simultaneous participation in another behavioural modification program
• having any clinical condition that precludes participation in a PA intervention (e.g., severe musculoskeletal or neurological disorders and unstable cardiovascular disease)
• another primary respiratory disease
• history of recent neoplasia (including last treatment) in the previous year.

Sponsors & Collaborators

• Instituto Politécnico de Leiria: lead
• Unidade Local de Saúde do Baixo Mondego: collaborator
• Unidade Local de Saúde de Lisboa Norte: collaborator
• Faculdade de Motricidade Humana de Lisboa: collaborator

Study Sites (1)

Center for Innovative Care and Health Technology (ciTechCare), Polytechnic of Leiria

Leiria, 2414-016, Portugal

RECRUITING

Related Publications (41)

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MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Sofia Flora, PT, MSc

  Center for Innovative Care and Health Technology, Polytechnic of Leiria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sofia Flora, PT, MSc

CONTACT

+351 917257840; sofia.flora@ipleiria.pt

Joana Cruz, PT, PhD

CONTACT

969196218; joana.cruz@ipleiria.pt

Study Design

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

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 13, 2024
• Study Start: December 2, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)