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Pulmonary Disease, Chronic ObstructiveNCT05173532

The Prescriptive Validity of a Novel Fall Risk Clinical Prediction Rule for People With COPD

A study testing Balance Training and Breathing and Stretching Exercises in people with Pulmonary Disease, Chronic Obstructive, run by Texas Woman's University at 4 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study has 3 objectives: (1) demonstrate the effectiveness of balance training for people with COPD, (2) determine which patients with COPD respond best to balance training, and (3) calculate clinically meaningful changes in balance for patients with COPD. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
Balance Training and Breathing and Stretching Exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
4 sitesUnited States
Study dates
10 Feb 2021to 31 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • having reported a fall in the past 5 years, or a near fall in the past year, or a score ≥ 9 on the Short Version of the Falls Efficacy Scale - International Version
  • age ≥ 60 years
  • both sexes
  • spirometrically-confirmed COPD of all disease severity stages
  • being independently ambulatory with or without a gait aid
  • medical clearance by a physician to participate in pulmonary rehabilitation
  • provision of informed consent.

Who cannot join

  • having suffered a recent, severe COPD exacerbation (recent is 30 days or less prior to the study baseline)
  • participation in a formal exercise program in the three months prior to the study baseline
  • an inability by the patient to complete all study testing due to physical, psychological, communication-barrier, or other unanticipated reasons.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Breathing Center of Houston

    Houston, Texas, 77077

  • Breathing Center of Houston

    Houston, Texas, 77081

  • Breathing Center of Houston

    Sugar Land, Texas, 77479

  • Breathing Center of Houston

    Webster, Texas, 77598

Other trials in United States

About this study

This study has 3 objectives: (1) demonstrate the effectiveness of balance training for people with COPD, (2) determine which patients with COPD respond best to balance training, and (3) calculate clinically meaningful changes in balance for patients with COPD.

Read the detailed description

After receiving a detailed explanation of the study, including its risks and benefits, and providing informed consent, patients will be screened for eligibility criteria during a single 75-minute evaluation for participation in a physical therapy based pulmonary rehabilitation program. Those meeting eligibility criteria will be randomly assigned in blocks of four (by clinical site) in a single-blind manner (patients) in a 1:1 ratio to either balance training or a breathing and stretching exercise program. Both groups will receive respiratory muscle stretch exercises, aerobic exercise, strength training, and fall prevention education. The intervention phase will last 8 weeks, with patients being seen 3 times per week for 75 minute sessions supervised by a physical therapist or physical therapist assistant.

Being tested
Balance Training, Breathing and Stretching Exercises
Keywords
Balance, Falls, Fall Risk, Aerobic Exercise, Strength Training, Fall Prevention, Stretching Exercise, Breathing Exercise, Randomized Controlled Trial, Clinical Prediction Rule, Minimal Clinically Important Difference
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Balance TrainingOther

    static and dynamic balance and gait stability exercises

  • Breathing and Stretching ExercisesOther

    static stretching while performing diaphragmatic breathing

Study groups in NCT05173532
Study groupRoleWhat they receive
Balance TrainingExperimentalStatic and dynamic balance and gait stability training exercises are performed with supervision by a physical therapist or physical therapist assistant for 30 minutes, 3 times per week, for 8 weeks.
Receives: Other: Balance Training
Breathing and Stretching ExercisesActive comparatorPatients perform static stretches for all major muscle groups while performing diaphragmatic breathing with supervision by a physical therapist or physical therapist assistant for 30 minutes, 3 times per week, for 8 weeks.
Receives: Other: Breathing and Stretching Exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Brief Balance Evaluation Systems Test total score baseline to 4 weeks

    8-item balance test battery, each item rated from 0-3 then summed for total score, items #3 and #4 are tested on both the right and left side. (#1) HIP/TRUNK LATERAL STRENGTH, (#2) FUNCTIONAL REACH FORWARD, (#3) SINGLE-LEG STANCE, (#4) COMPENSATORY STEPPING CORRECTION- LATERAL, (#5) STAND ON FOAM, EYES CLOSED: (3) 30s stable (2) 30s unstable (1) < 30s (0) Unable, (#6) TIMED "GET UP \& GO"

    Measured: 4 weeks

  2. Change in Brief Balance Evaluation Systems Test total score baseline to 8 weeks

    8-item balance test battery, each item rated from 0-3, then summed for total score, items #3 and #4 are tested on both the right and left side. (#1) HIP/TRUNK LATERAL STRENGTH, (#2) FUNCTIONAL REACH FORWARD, (#3) SINGLE-LEG STANCE, (#4) COMPENSATORY STEPPING CORRECTION- LATERAL, (#5) STAND ON FOAM, EYES CLOSED: (3) 30s stable (2) 30s unstable (1) < 30s (0) Unable, (#6) TIMED "GET UP \& GO"

    Measured: 8 weeks

Secondary outcomes (2)

  1. Global Rating of Change in Balance after 4 weeks

    11-point self-report outcome rating balance improvement(+) or decline(-). Ratings: (+/-5)="very large", (+/-4)="large", (+/-3)="medium", (+/-2)="small", (+/-1)="very small", (0)="none"

    Measured: 4 weeks

  2. Global Rating of Change in Balance after 8 weeks

    11-point self-report outcome rating balance improvement(+) or decline(-). Ratings: (+/-5)="very large", (+/-4)="large", (+/-3)="medium", (+/-2)="small", (+/-1)="very small", (0)="none"

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2021
  2. Study start10 Feb 2021
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05173532
Sponsor's protocol ID
IRB-FY2021-1
Status last verified
Apr 2022
First submitted
19 Feb 2021
Last updated
27 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Beauchamp MK, Janaudis-Ferreira T, Parreira V, Romano JM, Woon L, Goldstein RS, Brooks D. A randomized controlled trial of balance training during pulmonary rehabilitation for individuals with COPD. Chest. 2013 Dec;144(6):1803-1810. doi: 10.1378/chest.13-1093.

    PubMed 23975185

  • Delbaere K, Close JC, Mikolaizak AS, Sachdev PS, Brodaty H, Lord SR. The Falls Efficacy Scale International (FES-I). A comprehensive longitudinal validation study. Age Ageing. 2010 Mar;39(2):210-6. doi: 10.1093/ageing/afp225. Epub 2010 Jan 8.

    PubMed 20061508

  • Buist AS, McBurnie MA, Vollmer WM, Gillespie S, Burney P, Mannino DM, Menezes AM, Sullivan SD, Lee TA, Weiss KB, Jensen RL, Marks GB, Gulsvik A, Nizankowska-Mogilnicka E; BOLD Collaborative Research Group. International variation in the prevalence of COPD (the BOLD Study): a population-based prevalence study. Lancet. 2007 Sep 1;370(9589):741-50. doi: 10.1016/S0140-6736(07)61377-4.

    PubMed 17765523

  • Vogelmeier CF, Criner GJ, Martinez FJ, Anzueto A, Barnes PJ, Bourbeau J, Celli BR, Chen R, Decramer M, Fabbri LM, Frith P, Halpin DM, Lopez Varela MV, Nishimura M, Roche N, Rodriguez-Roisin R, Sin DD, Singh D, Stockley R, Vestbo J, Wedzicha JA, Agusti A. Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Lung Disease 2017 Report: GOLD Executive Summary. Respirology. 2017 Apr;22(3):575-601. doi: 10.1111/resp.13012. Epub 2017 Mar 7.

    PubMed 28150362

  • Moon Y, Sosnoff JJ. Safe Landing Strategies During a Fall: Systematic Review and Meta-Analysis. Arch Phys Med Rehabil. 2017 Apr;98(4):783-794. doi: 10.1016/j.apmr.2016.08.460. Epub 2016 Aug 31.

    PubMed 27592402

  • Burton E, Farrier K, Lewin G, Petrich M, Boyle E, Hill KD. Are interventions effective in improving the ability of older adults to rise from the floor independently? A mixed method systematic review. Disabil Rehabil. 2020 Mar;42(6):743-753. doi: 10.1080/09638288.2018.1508509. Epub 2018 Dec 4.

    PubMed 30512983

  • Avin KG, Hanke TA, Kirk-Sanchez N, McDonough CM, Shubert TE, Hardage J, Hartley G; Academy of Geriatric Physical Therapy of the American Physical Therapy Association. Management of falls in community-dwelling older adults: clinical guidance statement from the Academy of Geriatric Physical Therapy of the American Physical Therapy Association. Phys Ther. 2015 Jun;95(6):815-34. doi: 10.2522/ptj.20140415. Epub 2015 Jan 8.

    PubMed 25573760

  • Lahousse L, Verlinden VJ, van der Geest JN, Joos GF, Hofman A, Stricker BH, Brusselle GG, Ikram MA. Gait patterns in COPD: the Rotterdam Study. Eur Respir J. 2015 Jul;46(1):88-95. doi: 10.1183/09031936.00213214. Epub 2015 Feb 19.

    PubMed 25700390

  • Morlino P, Balbi B, Guglielmetti S, Giardini M, Grasso M, Giordano C, Schieppati M, Nardone A. Gait abnormalities of COPD are not directly related to respiratory function. Gait Posture. 2017 Oct;58:352-357. doi: 10.1016/j.gaitpost.2017.08.020. Epub 2017 Aug 18.

    PubMed 28866454

  • Horak FB, Wrisley DM, Frank J. The Balance Evaluation Systems Test (BESTest) to differentiate balance deficits. Phys Ther. 2009 May;89(5):484-98. doi: 10.2522/ptj.20080071. Epub 2009 Mar 27.

    PubMed 19329772

  • Shumway-Cook A, Horak FB. Assessing the influence of sensory interaction of balance. Suggestion from the field. Phys Ther. 1986 Oct;66(10):1548-50. doi: 10.1093/ptj/66.10.1548. No abstract available.

    PubMed 3763708

  • Horak FB, Henry SM, Shumway-Cook A; New Collective Author. Postural perturbations: new insights for treatment of balance disorders. Phys Ther. 1997 May;77(5):517-33. doi: 10.1093/ptj/77.5.517.

    PubMed 9149762

  • Horak FB. Postural orientation and equilibrium: what do we need to know about neural control of balance to prevent falls? Age Ageing. 2006 Sep;35 Suppl 2:ii7-ii11. doi: 10.1093/ageing/afl077.

    PubMed 16926210

  • de Vries EA, Caljouw SR, Coppens MJ, Postema K, Verkerke GJ, Lamoth CJ. Differences between young and older adults in the control of weight shifting within the surface of support. PLoS One. 2014 Jun 3;9(6):e98494. doi: 10.1371/journal.pone.0098494. eCollection 2014.

    PubMed 24892646

  • Duncan PW, Weiner DK, Chandler J, Studenski S. Functional reach: a new clinical measure of balance. J Gerontol. 1990 Nov;45(6):M192-7. doi: 10.1093/geronj/45.6.m192.

    PubMed 2229941

Questions about this trial

What is this clinical trial studying?

A study testing Balance Training and Breathing and Stretching Exercises in people with Pulmonary Disease, Chronic Obstructive, run by Texas Woman's University at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Brief Balance Evaluation Systems Test total score baseline to 4 weeks (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05173532, which also lists 33 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.

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