Telehealth and Onsite Maintenance Exercise in Chronic Lung Disease

NCT06304207 | Recruiting

• 1 other identifier: 300423
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this pilot clinical trial is to compare telehealth and onsite supervised maintenance exercise program for adults with Chronic Lung Disease. The specific aims of the study are:

• To compare 8-week supervised maintenance program delivered onsite and via tele-rehab with no maintenance for patients with Chronic Lung Disease following discharge from traditional exercise or physical therapy or onsite outpatient rehabilitation programs on clinical outcomes (dyspnea, exercise capacity, physical function, physical activity, and quality of life) at 8 weeks and 4-months post-intervention.
• To compare the differences in dyspnea, exercise capacity, physical function, physical activity, and quality of life between an 8-week maintenance program delivered onsite and via tele-rehab at 8-weeks and 4-months post-intervention in patients with Chronic Lung Disease following discharge from traditional onsite outpatient rehabilitation. Participants in both intervention groups (onsite and tele-rehab) will undergo a baseline onsite assessment followed by an 8-week supervised exercise intervention either onsite or in a telehealth setting. Control group will receive biweekly check in calls, but no active intervention.

Conditions

Copd; COPD Exacerbation; COPD Bronchitis; Emphysema or COPD; Chronic Lung Disease; Pulmonary Fibrosis; Interstitial Lung Disease; Bronchiectasis; Chronic Asthma; Chronic Asthmatic Bronchitis

Outcome Measures

Primary Outcomes (12)

• Exercise Capacity

  Exercise capacity as measured by the six-minute walk distance

  At baseline

• Exercise Capacity

  Exercise capacity as measured by the six-minute walk distance

  At 8 weeks (end of the study)

• Exercise Capacity

  Exercise capacity as measured by the six-minute walk distance

  At 4 months follow up

• Dyspnea

  Dyspnea measured on the modified Medical Research Council (mMRC) scale score ranges from 0-4 with higher scores indicating greater shortness of breath

  At baseline

• Dyspnea

  Dyspnea measured on the modified Medical Research Council (mMRC) scale score ranges from 0-4 with higher scores indicating greater shortness of breath

  At 8 weeks (end of the study)

• Dyspnea

  Dyspnea measured on the modified Medical Research Council (mMRC) scale score ranges from 0-4 with higher scores indicating greater shortness of breath

  At 4 months follow up

• Physical Function

  Physical function measured by the 30 seconds chair rise test

  At baseline,

• Physical Function

  Physical function measured by the 30 seconds chair rise test

  At 8 weeks (end of the study),

• Physical Function

  Physical function measured by the 30 seconds chair rise test

  At 4 months follow up

• Quality of life measure

  Quality of life measured by the chronic obstructive pulmonary disease Assessment Test (CAT) scale. Score ranges from 0-40, with higher scores indicating a more severe impact on a patient's life

  At baseline

• Quality of life measure

  Quality of life measured by the chronic obstructive pulmonary disease Assessment Test (CAT) scale. Score ranges from 0-40, with higher scores indicating a more severe impact on a patient's life

  At 8 weeks (end of study)

• Quality of life measure

  Quality of life measured by the chronic obstructive pulmonary disease Assessment Test (CAT) scale. Score ranges from 0-40, with higher scores indicating a more severe impact on a patient's life

  At 4- month follow up

Secondary Outcomes (12)

• Inspiratory muscle strength

  At baseline, 8 weeks (end of the study), and at 4 months follow up

• Inspiratory muscle strength

  At baseline

• Inspiratory muscle strength

  At 8 weeks (end of the study)

• Physical activity

  At baseline

• Physical activity

  At 8 weeks (end of study)

Study Arms (3)

Control

NO INTERVENTION

Control group participants will only be seen during the outcomes assessments at the MGH Institute of Health Professions at times 0, 1, and 2, but will receive no active supervised intervention. Control group participants will go home with discharge instructions to maintain a home exercise routine provided to them at discharge. Bi-weekly check in phone calls from the study team will continue to ensure participant engagement in the study. During the phone calls, participants will be encouraged to keep a log of their weekly activities in a journal.

Onsite Pulmonary Rehab

EXPERIMENTAL

Supervised pulmonary rehabilitation including exercise training, activity counselling, and education provided onsite.

Combination Product: Onsite Maintenance Exercise Training

Telehealth Pulmonary Rehab

EXPERIMENTAL

Supervised pulmonary rehabilitation including exercise training, activity counselling, and education provided remotely using Zoom videoconferencing technology.

Combination Product: Telehealth Maintenance Exercise

Interventions

Onsite Maintenance Exercise Training COMBINATION_PRODUCT

Participants will receive a 60-minute supervised weekly exercise intervention for 8-weeks.Each 60-minute session will be broken down into a brief 5-minute training on inspiratory muscle training using a Threshold Inspiratory Muscle Trainer (IMT), 5-minute education on self-management of airway clearance and importance of maintaining regular physical activity; a 5-minute warm-up, and 25 minutes of aerobic training. The training intensity will be derived from the distance covered on the six-minute walk test administered at baseline. Training will be performed at 60-85% of VO2 reserve and converted to walking distance and speed using American College of Sports Medicine walking equations for treadmill and overground walking activities or a corresponding rating of perceived exertion (RPE) of 13-16 for non-walking activities. This will be followed by 15-minutes of functional strength training focusing on the lower extremity muscles, and 5 minutes of cool down with stretching exercises.

Also known as: Onsite Maintenance Pulmonary Rehab

Onsite Pulmonary Rehab

Telehealth Maintenance Exercise COMBINATION_PRODUCT

Participants in the tele-rehab group will also receive the same intervention as outlined for the onsite group. The mode of aerobic exercise will vary based on availability of equipment in patient homes. The intervention will be delivered remotely via previously researched models using a tablet computer. I-pads will be provided to the participants on a need basis to take home for the duration of the study. Videoconferencing will be via Partners log in enabled Zoom videoconferencing software (San Jose, California, USA) that allows all participants to see and speak to each other. To ensure safety and understanding of equipment operation and the exercise program, the initial training session and establishment of the home exercise program will occur during the initial onsite visit in the clinic at MGH Institute of Health Professions.

Also known as: Telehealth Maintenance Pulmonary Rehab

Telehealth Pulmonary Rehab

Eligibility Criteria

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

You may qualify if:

• All adult patients 40 years and older with physician diagnosed Chronic Lung Disease within 2 months of discharge following completion of a traditional onsite outpatient rehabilitation or physical therapy or exercise program for their condition
• Able to walk independently with or without mobility devices
• Able to complete a six-minute walk test at discharge with or without supplemental oxygen maintaining an oxygen saturation at or above 85%
• Able to follow commands and instructions in the English language
• Have ability to connect to the internet

You may not qualify if:

• Those with significant mobility limitations such as those with a history of stroke, neurological comorbidities such as Parkinson's disease or relapsing multiple sclerosis, or significant degenerative osteoarthritis, or any other joint impairments that compromise ability to walk independently with or without an assistive device.
• Patients who primarily rely on a wheelchair for mobility
• Patients with or without supplemental oxygen who are unable to complete a walking test without a drop in oxygen saturation to below 85% at discharge from traditional outpatient rehabilitation
• Patients with baseline hemodynamic compromise, unstable angina, a recent myocardial infarction within a week, uncontrollable atrial fibrillation not managed with medications, advanced stage heart failure (New York Heart Association class 4), or those with mechanical circulatory assist devices for the heart such a ventricular assist device (VADs)
• Inability to communicate in the English language

Sponsors & Collaborators

• MGH Institute of Health Professions: lead

Study Sites (1)

MGH Institute of Health Professions

Charlestown, Massachusetts, 02129, United States

RECRUITING

Related Publications (32)

• Halbert RJ, Natoli JL, Gano A, Badamgarav E, Buist AS, Mannino DM. Global burden of COPD: systematic review and meta-analysis. Eur Respir J. 2006 Sep;28(3):523-32. doi: 10.1183/09031936.06.00124605. Epub 2006 Apr 12.

  PMID: 16611654 BACKGROUND

• 2. American Association of Cardiovascular and Pulmonary Rehabilitation. Guidelines for cardiac rehabilitation and secondary prevention programs. . Champaign, IL: Human Kinetics; 2011.

  BACKGROUND

• Cruz J, Brooks D, Marques A. Home telemonitoring in COPD: a systematic review of methodologies and patients' adherence. Int J Med Inform. 2014 Apr;83(4):249-63. doi: 10.1016/j.ijmedinf.2014.01.008. Epub 2014 Jan 23.

  PMID: 24529402 BACKGROUND

• Rochester CL, Vogiatzis I, Holland AE, Lareau SC, Marciniuk DD, Puhan MA, Spruit MA, Masefield S, Casaburi R, Clini EM, Crouch R, Garcia-Aymerich J, Garvey C, Goldstein RS, Hill K, Morgan M, Nici L, Pitta F, Ries AL, Singh SJ, Troosters T, Wijkstra PJ, Yawn BP, ZuWallack RL; ATS/ERS Task Force on Policy in Pulmonary Rehabilitation. An Official American Thoracic Society/European Respiratory Society Policy Statement: Enhancing Implementation, Use, and Delivery of Pulmonary Rehabilitation. Am J Respir Crit Care Med. 2015 Dec 1;192(11):1373-86. doi: 10.1164/rccm.201510-1966ST.

  PMID: 26623686 BACKGROUND

• Bolton CE, Bevan-Smith EF, Blakey JD, Crowe P, Elkin SL, Garrod R, Greening NJ, Heslop K, Hull JH, Man WD, Morgan MD, Proud D, Roberts CM, Sewell L, Singh SJ, Walker PP, Walmsley S; British Thoracic Society Pulmonary Rehabilitation Guideline Development Group; British Thoracic Society Standards of Care Committee. British Thoracic Society guideline on pulmonary rehabilitation in adults. Thorax. 2013 Sep;68 Suppl 2:ii1-30. doi: 10.1136/thoraxjnl-2013-203808. No abstract available.

  PMID: 23880483 BACKGROUND

• Marciniuk DD, Brooks D, Butcher S, Debigare R, Dechman G, Ford G, Pepin V, Reid D, Sheel AW, Stickland MK, Todd DC, Walker SL, Aaron SD, Balter M, Bourbeau J, Hernandez P, Maltais F, O'Donnell DE, Bleakney D, Carlin B, Goldstein R, Muthuri SK; Canadian Thoracic Society COPD Committee Expert Working Group. Optimizing pulmonary rehabilitation in chronic obstructive pulmonary disease--practical issues: a Canadian Thoracic Society Clinical Practice Guideline. Can Respir J. 2010 Jul-Aug;17(4):159-68. doi: 10.1155/2010/425975.

  PMID: 20808973 BACKGROUND

• Marciniuk DD, Goodridge D, Hernandez P, Rocker G, Balter M, Bailey P, Ford G, Bourbeau J, O'Donnell DE, Maltais F, Mularski RA, Cave AJ, Mayers I, Kennedy V, Oliver TK, Brown C; Canadian Thoracic Society COPD Committee Dyspnea Expert Working Group. Managing dyspnea in patients with advanced chronic obstructive pulmonary disease: a Canadian Thoracic Society clinical practice guideline. Can Respir J. 2011 Mar-Apr;18(2):69-78. doi: 10.1155/2011/745047.

  PMID: 21499589 BACKGROUND

• 8. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management and Prevention of COPD. 2022.

  BACKGROUND

• Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, Hill K, Holland AE, Lareau SC, Man WD, Pitta F, Sewell L, Raskin J, Bourbeau J, Crouch R, Franssen FM, Casaburi R, Vercoulen JH, Vogiatzis I, Gosselink R, Clini EM, Effing TW, Maltais F, van der Palen J, Troosters T, Janssen DJ, Collins E, Garcia-Aymerich J, Brooks D, Fahy BF, Puhan MA, Hoogendoorn M, Garrod R, Schols AM, Carlin B, Benzo R, Meek P, Morgan M, Rutten-van Molken MP, Ries AL, Make B, Goldstein RS, Dowson CA, Brozek JL, Donner CF, Wouters EF; ATS/ERS Task Force on Pulmonary Rehabilitation. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med. 2013 Oct 15;188(8):e13-64. doi: 10.1164/rccm.201309-1634ST.

  PMID: 24127811 BACKGROUND

• Tsutsui M, Gerayeli F, Sin DD. Pulmonary Rehabilitation in a Post-COVID-19 World: Telerehabilitation as a New Standard in Patients with COPD. Int J Chron Obstruct Pulmon Dis. 2021 Feb 19;16:379-391. doi: 10.2147/COPD.S263031. eCollection 2021.

  PMID: 33642858 BACKGROUND

• Cameron-Tucker HL, Wood-Baker R, Joseph L, Walters JA, Schuz N, Walters EH. A randomized controlled trial of telephone-mentoring with home-based walking preceding rehabilitation in COPD. Int J Chron Obstruct Pulmon Dis. 2016 Aug 25;11:1991-2000. doi: 10.2147/COPD.S109820. eCollection 2016.

  PMID: 27601892 BACKGROUND

• Malaguti C, Dal Corso S, Janjua S, Holland AE. Supervised maintenance programmes following pulmonary rehabilitation compared to usual care for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2021 Aug 17;8(8):CD013569. doi: 10.1002/14651858.CD013569.pub2.

  PMID: 34404111 BACKGROUND

• 13. World Health Organization. WHO-ITU Global Standard for Accessibility of Telehealth Services. . 2022.

  BACKGROUND

• Ku BPS, Tse AWS, Pang BCH, Cheung NT, Pang JYW, Chan JKY, Hui HL, Chu D, Choi KHW. Tele-Rehabilitation to Combat Rehabilitation Service Disruption During COVID-19 in Hong Kong: Observational Study. JMIR Rehabil Assist Technol. 2021 Aug 19;8(3):e19946. doi: 10.2196/19946.

  PMID: 34254945 BACKGROUND

• Zanaboni P, Dinesen B, Hjalmarsen A, Hoaas H, Holland AE, Oliveira CC, Wootton R. Long-term integrated telerehabilitation of COPD Patients: a multicentre randomised controlled trial (iTrain). BMC Pulm Med. 2016 Aug 22;16(1):126. doi: 10.1186/s12890-016-0288-z.

  PMID: 27549782 BACKGROUND

• Zanaboni P, Lien LA, Hjalmarsen A, Wootton R. Long-term telerehabilitation of COPD patients in their homes: interim results from a pilot study in Northern Norway. J Telemed Telecare. 2013 Oct;19(7):425-9. doi: 10.1177/1357633X13506514.

  PMID: 24218358 BACKGROUND

• Cerdan-de-Las-Heras J, Balbino F, Lokke A, Catalan-Matamoros D, Hilberg O, Bendstrup E. Effect of a New Tele-Rehabilitation Program versus Standard Rehabilitation in Patients with Chronic Obstructive Pulmonary Disease. J Clin Med. 2021 Dec 21;11(1):11. doi: 10.3390/jcm11010011.

  PMID: 35011755 BACKGROUND

• Bernocchi P, Vitacca M, La Rovere MT, Volterrani M, Galli T, Baratti D, Paneroni M, Campolongo G, Sposato B, Scalvini S. Home-based telerehabilitation in older patients with chronic obstructive pulmonary disease and heart failure: a randomised controlled trial. Age Ageing. 2018 Jan 1;47(1):82-88. doi: 10.1093/ageing/afx146.

  PMID: 28985325 BACKGROUND

• Crisafulli E, Clini EM. Measures of dyspnea in pulmonary rehabilitation. Multidiscip Respir Med. 2010 Jun 30;5(3):202-10. doi: 10.1186/2049-6958-5-3-202.

  PMID: 22958431 BACKGROUND

• Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.

  PMID: 12900694 BACKGROUND

• Jones PW, Harding G, Berry P, Wiklund I, Chen WH, Kline Leidy N. Development and first validation of the COPD Assessment Test. Eur Respir J. 2009 Sep;34(3):648-54. doi: 10.1183/09031936.00102509.

  PMID: 19720809 BACKGROUND

• Lapin BR, Kinzy TG, Thompson NR, Krishnaney A, Katzan IL. Accuracy of Linking VR-12 and PROMIS Global Health Scores in Clinical Practice. Value Health. 2018 Oct;21(10):1226-1233. doi: 10.1016/j.jval.2018.03.011. Epub 2018 Apr 26.

  PMID: 30314624 BACKGROUND

• Schalet BD, Rothrock NE, Hays RD, Kazis LE, Cook KF, Rutsohn JP, Cella D. Linking Physical and Mental Health Summary Scores from the Veterans RAND 12-Item Health Survey (VR-12) to the PROMIS((R)) Global Health Scale. J Gen Intern Med. 2015 Oct;30(10):1524-30. doi: 10.1007/s11606-015-3453-9. Epub 2015 Jul 16.

  PMID: 26179820 BACKGROUND

• Formiga MF, Roach KE, Vital I, Urdaneta G, Balestrini K, Calderon-Candelario RA, Campos MA, Cahalin LP. Reliability and validity of the test of incremental respiratory endurance measures of inspiratory muscle performance in COPD. Int J Chron Obstruct Pulmon Dis. 2018 May 15;13:1569-1576. doi: 10.2147/COPD.S160512. eCollection 2018.

  PMID: 29805255 BACKGROUND

• COPD Foundation. COPD Foundation Educational Materials. In:2023.

  BACKGROUND

• Ross RM, Murthy JN, Wollak ID, Jackson AS. The six minute walk test accurately estimates mean peak oxygen uptake. BMC Pulm Med. 2010 May 26;10:31. doi: 10.1186/1471-2466-10-31.

  PMID: 20504351 BACKGROUND

• Thompson PD, Arena R, Riebe D, Pescatello LS; American College of Sports Medicine. ACSM's new preparticipation health screening recommendations from ACSM's guidelines for exercise testing and prescription, ninth edition. Curr Sports Med Rep. 2013 Jul-Aug;12(4):215-7. doi: 10.1249/JSR.0b013e31829a68cf. No abstract available.

  PMID: 23851406 BACKGROUND

• Beaumont M, Mialon P, Le Ber C, Le Mevel P, Peran L, Meurisse O, Morelot-Panzini C, Dion A, Couturaud F. Effects of inspiratory muscle training on dyspnoea in severe COPD patients during pulmonary rehabilitation: controlled randomised trial. Eur Respir J. 2018 Jan 25;51(1):1701107. doi: 10.1183/13993003.01107-2017. Print 2018 Jan.

  PMID: 29371379 BACKGROUND

• de Souza E Silva CG, Kaminsky LA, Arena R, Christle JW, Araujo CGS, Lima RM, Ashley EA, Myers J. A reference equation for maximal aerobic power for treadmill and cycle ergometer exercise testing: Analysis from the FRIEND registry. Eur J Prev Cardiol. 2018 May;25(7):742-750. doi: 10.1177/2047487318763958. Epub 2018 Mar 8.

  PMID: 29517365 BACKGROUND

• Billinger SA, VAN Swearingen E, McClain M, Lentz AA, Good MB. Recumbent stepper submaximal exercise test to predict peak oxygen uptake. Med Sci Sports Exerc. 2012 Aug;44(8):1539-44. doi: 10.1249/MSS.0b013e31824f5be4.

  PMID: 22382170 BACKGROUND

• Herda AA, Lentz AA, Mattlage AE, Sisante JF, Billinger SA. Cross-validation of the recumbent stepper submaximal exercise test to predict peak oxygen uptake in older adults. Phys Ther. 2014 May;94(5):722-9. doi: 10.2522/ptj.20130307. Epub 2014 Jan 16.

  PMID: 24435104 BACKGROUND

• Karim R, Smith L, Baldwin J, Pham R, Kim HJ, Miccile L, Sullivan M, Gore S. Comparison of Telehealth and Onsite Supervised Maintenance Exercise Programs for Adults With Chronic Lung Disease: Protocol for a Pilot Randomized Feasibility Trial. JMIR Res Protoc. 2025 Aug 25;14:e71039. doi: 10.2196/71039.

  PMID: 40854211 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Emphysema; Pulmonary Fibrosis; Lung Diseases, Interstitial; Bronchiectasis

Condition Hierarchy (Ancestors)

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

Study Officials

• Shweta Gore, PhD

  MGH Institute of Health Professions

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shweta Gore, PhD

CONTACT

9895256619; sgore@mghihp.edu

Jane Baldwin, DPT

CONTACT

6177242230; JBALDWIN@MGHIHP.EDU

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All baseline and follow up outcomes assessment will be conducted by a study team member blinded to the subject group allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The study design will be a pilot randomized controlled, assessor-blinded trial with three groups: 1) Tele-rehab where patient will be at home but will receive supervised intervention remotely, 2) Onsite outpatient physical therapy, 3) Control group.

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: March 12, 2024
• Study Start: September 1, 2023
• Primary Completion: December 30, 2025
• Study Completion: March 1, 2026
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)