General Health, Attitudes, and Activity in Self-directed Exercise in Patients With Cystic Fibrosis (GAINS-CF)

NCT04882267 | Unknown DMC

• 1 other identifier: HSR200451-GAINS-CF
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

Exercise helps people with CF lead long, fulfilling lives. Regular exercise reduces depression and fatigue, and may play a role in preventing exacerbation. However, little is known about exercise habits in adults with CF, or the barriers to exercise that they face. During the COVID-19 pandemic, lockdowns and social distancing saw gym memberships plummet; while sale of personal exercise technology, smart-watches, and interactive home equipment exploded. As this technology becomes more cost-effective and accessible, can it be leveraged to improve CF care? This study will examine barriers to exercise in CF and the role of smart devices in exercise. Adults with CF will participate in the Exercise Behaviors/Barriers Survey, followed by a qualitative discussion on attitudes toward exercise technology, and how CF impacts exercise. We anticipate that many perceived barriers will be universal (e.g. time), while others will be unique to CF. Participants will be fitted with wrist actigraphy (FitBit Inspire 2) to measure baseline exercise. They will receive access to three smartphone apps designed for home exercise, as well as an exercise website designed for the CF community (www.activate65.org), and receive weekly phone calls from the CF care team offering motivational interviewing. Actigraphy, heart and respiratory rate, and app usage will be analyzed. After four weeks, participants will no longer receive calls. Actigraphy will be monitored four additional weeks to determine if exercise is sustained. We anticipate that exercise will increase during the intervention period, and that some activity will be sustained in the follow up period. The findings of this study will pave the way for a larger trial using this "Team and Technology" approach to investigate clinical outcomes. This study highlights the critical and timely need to investigate the barriers to exercise in CF, and effective solutions to develop sustainable exercise habits using widely-available technology from home.

Conditions

Cystic Fibrosis

Keywords

exercise; cystic fibrosis; CF; mental health

Outcome Measures

Primary Outcomes (4)

• Activity levels

  Activity measured in steps per day

  ten weeks

• Activity levels

  Activity measured by heart rate above target in minutes per day

  ten weeks

• Perceived barriers and benefits of exercise

  Perceived barriers and benefits of exercise as measured by serial EB/BS surveys

  ten weeks

• General and Mental Health

  General and mental health scores as measured by the GHQ 12

  ten weeks

Study Arms (4)

Determination of attitudes and perceived barriers to exercise

NO INTERVENTION

Adults with CF will take part in a quantitative modified Exercise Benefits/Barriers Scale (EB/BS) survey to identify universal and unique benefits and barriers to regular exercise activity. Subjects will be surveyed on potential ways to engage in exercise, including perceptions and prior use of smart device exercise technology. Qualitative input will be incorporated to better understand potential solutions to barriers, and develop more personalized plans for exercise engagement.

Determination of baseline exercise activity (Baseline Period)

NO INTERVENTION

Adults with CF who identify as 'willing to use technology' and own compatible smart phones/tablets will undergo the Short General Health Questionnaires (GHQ 12) to establish baseline levels of general and mental health. Subjects will be fitted with wrist actigraphy and monitored for four weeks to establish baseline levels of exercise activity at home. Anticipated outcomes: Access to actigraphy will encourage personal accountability, and physical activity will increase during the first two weeks before reaching a plateau.

Engagement in home self-directed exercise incorporating Team and Technology (Intervention Period)

EXPERIMENTAL

Subjects will take part in a live demonstration of three subscription-based AI-learning home exercise apps, and one self-directed exercise website designed by a CF patient partner. Subjects will be surveyed on willingness to use technology, and provide feedback on exercise options. They will be given free full access to the apps and website ("Technology"), and receive a phone call once a week from their CF specialty team offering encouragement and positive reinforcement ("Team"). App and website usage, actigraphy, EB/BS and GHQ 12 scores will be measured at the end of four weeks. Anticipated outcomes: Activity will increase significantly during the Team and Technology intervention period, barriers on the EB/BS score will decrease, and GHQ 12 scores will increase.

Behavioral: Team and Technology

Determination of sustainability (Sustainability Period)

ACTIVE COMPARATOR

Phone calls will cease, but subjects will maintain access to apps, websites, and actigraphy. After four weeks, EB/BS and GHQ 12 scores, physical activity, app and website use will be reassessed. Anticipated outcomes: Activity will decrease during the sustainability period, but will remain significantly greater than the pre-intervention period. Overall GHQ 12 and EB/BS scores will improve.

Behavioral: Team and Technology

Interventions

Team and Technology BEHAVIORAL

Subjects will receive access and instruction on multiple home exercise apps. They will receive phone calls once a week from care team members for motivational interviewing to encourage exercise.

Determination of sustainability (Sustainability Period); Engagement in home self-directed exercise incorporating Team and Technology (Intervention Period)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 and above
• Must have access to either Google Play (Google LLC) or Apple (Apple Inc.) smart device
• Patients of the University of Virginia Adult CF clinic

You may not qualify if:

• Unable to exercise based on PAR-Q survey
• Known physical condition that precludes exercise
• Pregnant, or trying to become pregnant
• Unable to provide informed consent
• Prisoners
• Does not own and feel comfortable using a smart device
• Unwilling to use smart devices for research purposes

Sponsors & Collaborators

• University of Virginia: lead

Related Publications (10)

• Nixon PA, Orenstein DM, Kelsey SF, Doershuk CF. The prognostic value of exercise testing in patients with cystic fibrosis. N Engl J Med. 1992 Dec 17;327(25):1785-8. doi: 10.1056/NEJM199212173272504.

  PMID: 1435933 BACKGROUND

• Hulzebos EH, Bomhof-Roordink H, van de Weert-van Leeuwen PB, Twisk JW, Arets HG, van der Ent CK, Takken T. Prediction of mortality in adolescents with cystic fibrosis. Med Sci Sports Exerc. 2014 Nov;46(11):2047-52. doi: 10.1249/MSS.0000000000000344.

  PMID: 24848493 BACKGROUND

• Sharma R, Florea VG, Bolger AP, Doehner W, Florea ND, Coats AJ, Hodson ME, Anker SD, Henein MY. Wasting as an independent predictor of mortality in patients with cystic fibrosis. Thorax. 2001 Oct;56(10):746-50. doi: 10.1136/thorax.56.10.746.

  PMID: 11562511 BACKGROUND

• Orava C, Fitzgerald J, Figliomeni S, Lam D, Naccarato A, Szego E, Yoshida K, Fox P, Sykes J, Wu K. Relationship between Physical Activity and Fatigue in Adults with Cystic Fibrosis. Physiother Can. 2018;70(1):42-48. doi: 10.3138/ptc.2016-75.

  PMID: 29434417 BACKGROUND

• Carek PJ, Laibstain SE, Carek SM. Exercise for the treatment of depression and anxiety. Int J Psychiatry Med. 2011;41(1):15-28. doi: 10.2190/PM.41.1.c.

  PMID: 21495519 BACKGROUND

• Shelley J, Boddy LM, Knowles ZR, Stewart CE, Dawson EA. Physical activity and associations with clinical outcome measures in adults with cystic fibrosis; a systematic review. J Cyst Fibros. 2019 Sep;18(5):590-601. doi: 10.1016/j.jcf.2019.03.003. Epub 2019 Mar 27.

  PMID: 30926321 BACKGROUND

• Jantzen A, Opoku-Pare M, Bieli C, Ruf K, Hebestreit H, Moeller A. Perspective on cystic fibrosis and physical activity: Is there a difference compared to healthy individuals? Pediatr Pulmonol. 2016 Oct;51(10):1020-1030. doi: 10.1002/ppul.23532. Epub 2016 Jul 26.

  PMID: 27459056 BACKGROUND

• Thomson RL, Buckley JD, Brinkworth GD. Perceived exercise barriers are reduced and benefits are improved with lifestyle modification in overweight and obese women with polycystic ovary syndrome: a randomised controlled trial. BMC Womens Health. 2016 Mar 9;16:14. doi: 10.1186/s12905-016-0292-8.

  PMID: 26960762 BACKGROUND

• Anjara SG, Bonetto C, Van Bortel T, Brayne C. Using the GHQ-12 to screen for mental health problems among primary care patients: psychometrics and practical considerations. Int J Ment Health Syst. 2020 Aug 10;14:62. doi: 10.1186/s13033-020-00397-0. eCollection 2020.

  PMID: 32793301 BACKGROUND

• Rovedder PM, Flores J, Ziegler B, Casarotto F, Jaques P, Barreto SS, Dalcin Pde T. Exercise programme in patients with cystic fibrosis: a randomized controlled trial. Respir Med. 2014 Aug;108(8):1134-40. doi: 10.1016/j.rmed.2014.04.022. Epub 2014 Jun 26.

  PMID: 25002195 BACKGROUND

MeSH Terms

Conditions

Cystic Fibrosis; Motor Activity; Psychological Well-Being

Interventions

Technology

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Behavior; Personal Satisfaction

Intervention Hierarchy (Ancestors)

Technology, Industry, and Agriculture

Study Officials

• Lindsay Somerville, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lindsay Somerville, MD

CONTACT

434-303-1125; ll7y@virginia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director of Adult CF Medicine

Model Details: Subjects will serve as own controls to establish a baseline of physical activity (first arm). After the baseline period, subjects will partake in the 4-week intervention in which they receive access to home exercise apps and receive motivational interviewing phone calls (second arm). After the intervention period, subjects will continue to have access to apps, but no longer receive phone calls. Activity and surveys will be measured at the end of 4 weeks (third arm).

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 11, 2021
• Study Start: May 31, 2021
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: May 11, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share