A Home-based Physical Activity Programme for Patients With Advanced Interstitial Lung Diseases (iLiFE)

NCT04224233 | Completed

• 1 other identifier: SFRH/BD/148741/2019
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Interstitial lung diseases (ILD) are a highly incapacitating group of chronic respiratory diseases, leading to disabling symptoms and impaired capacity to perform activities of daily living and health-related quality of life (HRQoL). It is known that people with ILD are highly inactive and sedentary, and in a severe stage of the disease, these people spend most of the time at home, increasing dependency on others, and decrease HRQoL. Physical activity is a cost-effective intervention, which increases the HRQoL, exercise capacity and ability to perform activities of daily living in people with chronic respiratory diseases. However, few home-based physical activity programmes are available, especially in people with ILD. Thus, it is urgent to develop innovative models of PA, closer to patients and adjusted to the patients' routines, to engage and change patients' physical activity levels, enhancing HRQoL. iLiFE might be promising as it focuses on establishing new behaviours, within selected contexts to stimulate home-based PA. Therefore, iLiFE will be developed, implemented and evaluated in people with ILD.

Conditions

Interstitial Lung Diseases (ILD)

Keywords

Physical activity; Home-based; Interstitial lung diseases; Lifestyle

Outcome Measures

Primary Outcomes (4)

• Change in Physical activity levels (steps/day) at 12-weeks

  Accelerometer-based activity monitors. Physical activity levels will be collected with the activity monitors GT3X+ (ActiGraph) to measure the number of steps/day.

  Assessment at baseline and 12-week (immediately after iLiFE)

• Change in Physical activity levels (steps/day) at 3 months

  Accelerometer-based activity monitors. Physical activity levels will be collected with the activity monitors GT3X+ (ActiGraph) to measure the number of steps/day.

  Assessment at baseline and 3 months after iLiFE.

• Change in Physical activity levels (steps/day) at 6 months

  Accelerometer-based activity monitors. Physical activity levels will be collected with the activity monitors GT3X+ (ActiGraph) to measure the number of steps/day.

  Assessment at baseline and 6 months after iLiFE.

• Change in physical activity levels (time spent in sedentary, light, lifestyle, moderate and vigorous physical activities)

  Accelerometer-based activity monitors. Physical activity levels will be collected with the activity monitors GT3X+ (ActiGraph) to measure the daily energy expenditure during one week.

  Multiple time points through study completion - immediately after iLiFE, and up to 3 and 6 months after iLiFE.

Secondary Outcomes (19)

• Change in health-related quality of life - The King's Brief Interstitial Lung Disease (KBILD) questionnaire.

  Assessment at baseline, 12-week (immediately after iLiFE), 3 and 6 months after iLiFE.

• Change in symptom's impact in patients' life

  Assessment at baseline, 4-weeks (after the programme start), 12-weeks (immediately after iLiFE), 3 and 6 months after iLiFE.

• Change in self-reported dyspnoea

  Assessment at baseline, 4-weeks (after the programme start), 12-weeks (immediately after iLiFE), 3 and 6 months after iLiFE.

• Change in quadriceps muscle strength

  Assessment at baseline, 4-weeks (after the programme start), 12-weeks (immediately after iLiFE), 3 and 6 months after iLiFE.

• Change in handgrip strength

  Assessment at baseline, 4-weeks (after the programme start), 12-weeks (immediately after iLiFE), 3 and 6 months after iLiFE.

Other Outcomes (4)

• Change in Body Mass Index

  Assessment at baseline, 4-weeks (after the programme start), 12-weeks (immediately after iLiFE), 3 and 6 months after iLiFE.

• Change in number of medications.

  Assessment at baseline, 4-weeks (after the programme start), 12-weeks (immediately after iLiFE), 3 and 6 months after iLiFE.

• Change in the dose of medication

  Assessment at baseline, 4-weeks (after the programme start), 12-weeks (immediately after iLiFE), 3 and 6 months after iLiFE.

Study Arms (2)

Home-based physical activity group

EXPERIMENTAL

The experimental group will receive the iLiFE.

Other: Home-based physical activity programme

Control group

ACTIVE COMPARATOR

The control group will receive a leaflet with exercises and PA recommendations.

Other: Usual care

Interventions

Home-based physical activity programme OTHER

iLiFE is a 12-week individualised programme, adapted to the participants' needs and preferences. This programme will be conducted in participants' home and include everyday tasks to train endurance, balance, flexibility and strength. The intervention incudes face-to-face sessions and phone calls. Face-to-face sessions aim to adapt activities to everyday tasks, increase frequency and/or intensity, monitor progress, clarify doubts, motivate higher daily energy expenditure and manage expectations. Phone-calls aim to clarify doubts and to monitor patients' motivation/evolution, following a motivational interview. At the start of the program, the physiotherapist will be present at all sessions, but these face-to-face visits will decrease over time. Patients will also receive a personalised manual (iLiFE manual) with activities to do in their everyday tasks.

Home-based physical activity group

Usual care OTHER

Participants will receive a leaflet with exercises and PA recommendations.

Control group

Eligibility Criteria

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

You may qualify if:

• clinical diagnosis of a interstitial lung disease
• clinically stable in the previous month
• ≥ 18 years old
• Living at home, assisted-home or at familiar home.

You may not qualify if:

• cognitive impairments
• inability to understand and co-operate
• history of neoplasic /immunologic disease or acute cardiac condition or a significant cardiac, musculoskeletal, neuromuscular or psychiatric condition
• Participating in pulmonary rehabilitation or have participated in last 6 months.

Sponsors & Collaborators

• Aveiro University: lead
• Fundação para a Ciência e a Tecnologia: collaborator
• Centro Hospitalar do Baixo Vouga: collaborator

Study Sites (1)

University of Aveiro

Aveiro, 3810-193, Portugal

Location

Related Publications (32)

• Tonelli R, Cocconcelli E, Lanini B, Romagnoli I, Florini F, Castaniere I, Andrisani D, Cerri S, Luppi F, Fantini R, Marchioni A, Beghe B, Gigliotti F, Clini EM. Effectiveness of pulmonary rehabilitation in patients with interstitial lung disease of different etiology: a multicenter prospective study. BMC Pulm Med. 2017 Oct 10;17(1):130. doi: 10.1186/s12890-017-0476-5.

  PMID: 29017478 BACKGROUND

• Dowman L, Hill CJ, Holland AE. Pulmonary rehabilitation for interstitial lung disease. Cochrane Database Syst Rev. 2014 Oct 6;(10):CD006322. doi: 10.1002/14651858.CD006322.pub3.

  PMID: 25284270 BACKGROUND

• Ryerson CJ, Cayou C, Topp F, Hilling L, Camp PG, Wilcox PG, Khalil N, Collard HR, Garvey C. Pulmonary rehabilitation improves long-term outcomes in interstitial lung disease: a prospective cohort study. Respir Med. 2014 Jan;108(1):203-10. doi: 10.1016/j.rmed.2013.11.016. Epub 2013 Dec 4.

  PMID: 24332409 BACKGROUND

• Shah RJ, Collard HR, Morisset J. Burden, resilience and coping in caregivers of patients with interstitial lung disease. Heart Lung. 2018 May-Jun;47(3):264-268. doi: 10.1016/j.hrtlng.2018.03.004. Epub 2018 Apr 4.

  PMID: 29627072 BACKGROUND

• World Health Organization. Steps to health: A European framework to promote physical activity for health. Copenhagen: WHO Regional Office for Europe; 2007.

  BACKGROUND

• Coultas DB, Jackson BE, Russo R, Peoples J, Singh KP, Sloan J, Uhm M, Ashmore JA, Blair SN, Bae S. Home-based Physical Activity Coaching, Physical Activity, and Health Care Utilization in Chronic Obstructive Pulmonary Disease. Chronic Obstructive Pulmonary Disease Self-Management Activation Research Trial Secondary Outcomes. Ann Am Thorac Soc. 2018 Apr;15(4):470-478. doi: 10.1513/AnnalsATS.201704-308OC.

  PMID: 29283670 BACKGROUND

• Root ED, Graney B, Baird S, Churney T, Fier K, Korn M, McCormic M, Sprunger D, Vierzba T, Wamboldt FS, Swigris JJ. Physical activity and activity space in patients with pulmonary fibrosis not prescribed supplemental oxygen. BMC Pulm Med. 2017 Nov 23;17(1):154. doi: 10.1186/s12890-017-0495-2.

  PMID: 29169394 BACKGROUND

• Perez-Bogerd S, Wuyts W, Barbier V, Demeyer H, Van Muylem A, Janssens W, Troosters T. Short and long-term effects of pulmonary rehabilitation in interstitial lung diseases: a randomised controlled trial. Respir Res. 2018 Sep 20;19(1):182. doi: 10.1186/s12931-018-0884-y.

  PMID: 30236104 BACKGROUND

• Wickerson L, Mathur S, Helm D, Singer L, Brooks D. Physical activity profile of lung transplant candidates with interstitial lung disease. J Cardiopulm Rehabil Prev. 2013 Mar-Apr;33(2):106-12. doi: 10.1097/HCR.0b013e3182839293.

  PMID: 23403914 BACKGROUND

• Interventions on Diet and Physical Activity: What Works: Summary Report. Geneva: World Health Organization; 2009. Available from http://www.ncbi.nlm.nih.gov/books/NBK177205/

  PMID: 24432437 BACKGROUND

• Clemson L, Fiatarone Singh MA, Bundy A, Cumming RG, Manollaras K, O'Loughlin P, Black D. Integration of balance and strength training into daily life activity to reduce rate of falls in older people (the LiFE study): randomised parallel trial. BMJ. 2012 Aug 7;345:e4547. doi: 10.1136/bmj.e4547.

  PMID: 22872695 BACKGROUND

• • World Health Organization. International Classification of Functioning, Disability and Health. ICF checklist. 2001.

  BACKGROUND

• Holland AE, Mahal A, Hill CJ, Lee AL, Burge AT, Cox NS, Moore R, Nicolson C, O'Halloran P, Lahham A, Gillies R, McDonald CF. Home-based rehabilitation for COPD using minimal resources: a randomised, controlled equivalence trial. Thorax. 2017 Jan;72(1):57-65. doi: 10.1136/thoraxjnl-2016-208514. Epub 2016 Sep 26.

  PMID: 27672116 BACKGROUND

• Borg G. Borg's perceived exertion and pain scales. HUman kinetics. 1998.

  BACKGROUND

• Papiris SA, Daniil ZD, Malagari K, Kapotsis GE, Sotiropoulou C, Milic-Emili J, Roussos C. The Medical Research Council dyspnea scale in the estimation of disease severity in idiopathic pulmonary fibrosis. Respir Med. 2005 Jun;99(6):755-61. doi: 10.1016/j.rmed.2004.10.018. Epub 2004 Nov 24.

  PMID: 15878493 BACKGROUND

• Graham BL, Steenbruggen I, Miller MR, Barjaktarevic IZ, Cooper BG, Hall GL, Hallstrand TS, Kaminsky DA, McCarthy K, McCormack MC, Oropez CE, Rosenfeld M, Stanojevic S, Swanney MP, Thompson BR. Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement. Am J Respir Crit Care Med. 2019 Oct 15;200(8):e70-e88. doi: 10.1164/rccm.201908-1590ST.

  PMID: 31613151 BACKGROUND

• Graham BL, Brusasco V, Burgos F, Cooper BG, Jensen R, Kendrick A, MacIntyre NR, Thompson BR, Wanger J. Executive Summary: 2017 ERS/ATS standards for single-breath carbon monoxide uptake in the lung. Eur Respir J. 2017 Jan 3;49(1):16E0016. doi: 10.1183/13993003.E0016-2016. Print 2017 Jan.

  PMID: 28049167 BACKGROUND

• Spruit MA, Sillen MJ, Groenen MT, Wouters EF, Franssen FM. New normative values for handgrip strength: results from the UK Biobank. J Am Med Dir Assoc. 2013 Oct;14(10):775.e5-11. doi: 10.1016/j.jamda.2013.06.013. Epub 2013 Aug 16.

  PMID: 23958225 BACKGROUND

• Dowman L, McDonald CF, Hill CJ, Lee A, Barker K, Boote C, Glaspole I, Goh N, Southcott A, Burge A, Ndongo R, Martin A, Holland AE. Reliability of the hand held dynamometer in measuring muscle strength in people with interstitial lung disease. Physiotherapy. 2016 Sep;102(3):249-55. doi: 10.1016/j.physio.2015.10.002. Epub 2015 Oct 22.

  PMID: 26596172 BACKGROUND

• Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.

  PMID: 1991946 BACKGROUND

• • Guralnik JM. Assessing Physical Performance in the Older Patient [CD-ROM]. In: Bethesda MD: National Institutes of Aging, editor. 2013.

  BACKGROUND

• Reuben DB, Siu AL. An objective measure of physical function of elderly outpatients. The Physical Performance Test. J Am Geriatr Soc. 1990 Oct;38(10):1105-12. doi: 10.1111/j.1532-5415.1990.tb01373.x.

  PMID: 2229864 BACKGROUND

• Skyes K. Chester Step Test. Publications WA, editor2003.

  BACKGROUND

• Direção-Geral da Saúde. Diagnóstico e tratamento da doença pulmonar obstrutiva crónica: norma nº 028/2011, de 30/09/2011, atualização de 10/09/2013. DGS Lisboa; 2013.

  BACKGROUND

• Reilly CC, Bausewein C, Garrod R, Jolley CJ, Moxham J, Higginson IJ. Breathlessness during daily activity: The psychometric properties of the London Chest Activity of Daily Living Scale in patients with advanced disease and refractory breathlessness. Palliat Med. 2017 Oct;31(9):868-875. doi: 10.1177/0269216316680314. Epub 2016 Dec 15.

  PMID: 27932629 BACKGROUND

• Pitta F, Probst VS, Kovelis D, Segretti NO, Mt Leoni A, Garrod R, Brunetto AF. Validation of the Portuguese version of the London Chest Activity of Daily Living Scale (LCADL) in chronic obstructive pulmonary disease patients. Rev Port Pneumol. 2008 Jan-Feb;14(1):27-47. English, Portuguese.

  PMID: 18265916 BACKGROUND

• Pais-Ribeiro J, Silva I, Ferreira T, Martins A, Meneses R, Baltar M. Validation study of a Portuguese version of the Hospital Anxiety and Depression Scale. Psychol Health Med. 2007 Mar;12(2):225-35; quiz 235-7. doi: 10.1080/13548500500524088. English, Portuguese.

  PMID: 17365902 BACKGROUND

• Webster K, Cella D, Yost K. The Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System: properties, applications, and interpretation. Health Qual Life Outcomes. 2003 Dec 16;1:79. doi: 10.1186/1477-7525-1-79.

  PMID: 14678568 BACKGROUND

• Gries KS, Esser D, Wiklund I. Content validity of CASA-Q cough domains and UCSD-SOBQ for use in patients with Idiopathic Pulmonary Fibrosis. Glob J Health Sci. 2013 Sep 16;5(6):131-41. doi: 10.5539/gjhs.v5n6p131.

  PMID: 24171881 BACKGROUND

• Swigris JJ, Esser D, Wilson H, Conoscenti CS, Schmidt H, Stansen W, Leidy NK, Brown KK. Psychometric properties of the St George's Respiratory Questionnaire in patients with idiopathic pulmonary fibrosis. Eur Respir J. 2017 Jan 18;49(1):1601788. doi: 10.1183/13993003.01788-2016. Print 2017 Jan.

  PMID: 28100551 BACKGROUND

• Dedding C, Cardol M, Eyssen IC, Dekker J, Beelen A. Validity of the Canadian Occupational Performance Measure: a client-centred outcome measurement. Clin Rehabil. 2004 Sep;18(6):660-7. doi: 10.1191/0269215504cr746oa.

  PMID: 15473118 BACKGROUND

• Holland AE, Watson A, Glaspole I. Comprehensive pulmonary rehabilitation for interstitial lung disease: A consensus approach to identify core education topics. Patient Educ Couns. 2019 Jun;102(6):1125-1130. doi: 10.1016/j.pec.2019.01.010. Epub 2019 Jan 16.

  PMID: 30683609 BACKGROUND

MeSH Terms

Conditions

Lung Diseases, Interstitial; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Behavior

Study Officials

• Alda S. Marques, PhD

  School of Health Sciences of the University of Aveiro (ESSUA)

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Intervention model

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: January 13, 2020
• Study Start: October 1, 2020
• Primary Completion: January 9, 2024
• Study Completion: January 9, 2024
• Last Updated: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)