- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07917195
Mind-Body Chair Yoga for Functional Mobility in Individuals With Lipedema (LIP-MOVE)
The Feasibility and Effectiveness of a Remote Mind-Body Chair Yoga Intervention on Functional Mobility in Individuals With Lipedema: A Randomized Controlled Trial
Lipedema is a chronic condition characterized by abnormal accumulation and distribution of adipose tissue, most commonly affecting the lower extremities, and may be associated with swelling, discomfort, reduced mobility, and changes in physical and emotional well-being. Although exercise and movement are commonly recommended as part of supportive care, there is limited clinical research examining whether a structured, remotely delivered mind-body chair yoga program can improve functional mobility in individuals with lipedema.
This study will evaluate the feasibility and effectiveness of a remote mind-body chair yoga intervention on functional mobility in adults with lipedema. The study builds on a previous citizen-science quality-of-life yoga program and is designed to further evaluate the intervention using a prospective clinical research design.
Participants will be randomly assigned in a 1:1 ratio to one of two groups. The intervention group will participate in a structured mind-body chair yoga program in addition to a weekly support group. The comparison group will participate in the weekly support group without yoga during the primary study period. After completion of the study, participants in the comparison group will be offered access to the chair yoga program.
The mind-body chair yoga intervention will be delivered remotely and will incorporate gentle chair-based yoga, breathing practices, relaxation, meditation, and other accessible mind-body practices. The program is designed to accommodate individuals with varying levels of mobility and physical ability and does not require participants to perform yoga poses on the floor.
The primary outcome of the study is functional mobility. Secondary outcomes will examine changes in lipedema symptom severity, pain, sleep, and mental well-being. Participant experiences and perceptions of the intervention will also be explored using qualitative measures.
The study will assess whether a remotely delivered mind-body chair yoga program is feasible for individuals with lipedema and whether participation is associated with improvements in functional mobility and other quality-of-life-related outcomes. Findings may help inform future research and the development of accessible mind-body movement programs for individuals living with lipedema.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
Lipedema is a chronic, often progressive adipose tissue disorder characterized by disproportionate and symmetrical accumulation of adipose tissue, most commonly affecting the lower extremities. The condition may be associated with swelling, tenderness or pain, heaviness, impaired physical function, and changes in body image and quality of life. Functional limitations may increase over time and can affect participation in daily activities and exercise.
Movement and exercise are commonly included among conservative approaches to managing lipedema. However, individuals with lipedema may experience physical limitations, discomfort, fatigue, reduced confidence with movement, or difficulty accessing exercise programs designed for their needs. Accessible movement approaches that can be adapted to different levels of mobility may therefore be particularly relevant to this population.
Yoga incorporates physical movement with breathing, attention regulation, relaxation, and other mind-body practices. Chair-based yoga provides an adaptable form of yoga that can be performed while seated and can be modified for individuals who have difficulty with floor-based exercise, prolonged standing, or conventional exercise programs. Mind-body practices incorporated into yoga may also provide potential benefits related to stress regulation, relaxation, sleep, and psychological well-being.
Despite the growing use of yoga and other mind-body practices among individuals with chronic health conditions, there is limited clinical research specifically examining remotely delivered chair-based mind-body yoga for people with lipedema. Additional research is needed to determine whether this type of intervention is feasible to deliver remotely and whether participation is associated with changes in functional mobility and other patient-reported outcomes relevant to lipedema.
The present study was developed from a prior citizen-science mind-body chair yoga program involving individuals with lipedema and/or lymphedema. That program explored changes in quality-of-life domains including pain, mobility, sleep, and mental health following a six-week gentle chair-based mind-body yoga intervention. The findings provided preliminary information supporting the feasibility of further investigation using a formal clinical research design. The current study is intended to extend that work by using a prospective, randomized, controlled design focused specifically on individuals with lipedema.
The study will evaluate a remotely delivered mind-body chair yoga intervention using a two-arm parallel-group design. Participants will be randomly assigned to either a mind-body chair yoga plus support-group intervention or a support-group-only comparison condition during the primary study period. The comparison condition is intended to provide social support and participant engagement while allowing evaluation of outcomes associated with the addition of the yoga intervention. Participants assigned to the comparison condition will subsequently be offered the opportunity to participate in the chair yoga program following completion of the primary study period.
The intervention is designed to be accessible to participants with varying levels of physical ability. Chair-based movement allows participants to remain seated for much of the practice while adapting movements according to individual needs and abilities. The mind-body component includes practices such as breathing, relaxation, meditation, and gentle movement. The remote format is intended to reduce barriers associated with travel and access to in-person programs and may provide a practical model for individuals who have difficulty attending conventional exercise or yoga classes.
The primary focus of the study is functional mobility. Functional mobility is an important aspect of quality of life for individuals with lipedema because limitations in movement may affect independence, participation in daily activities, physical activity, and overall well-being. The study will also examine additional patient-reported domains relevant to lipedema, including symptom severity, pain, sleep, and mental well-being.
In addition to quantitative measures, the study will collect information about participant experiences with the intervention. These data will help characterize how participants perceive the accessibility, acceptability, and usefulness of the program and may identify factors that influence participation and adherence.
The study is intended as a feasibility and effectiveness investigation and is not designed to establish that chair yoga is a treatment or cure for lipedema. Rather, it will provide preliminary clinical evidence regarding whether a structured, remotely delivered mind-body chair yoga intervention can be implemented with individuals with lipedema and whether participation is associated with changes in functional mobility and related quality-of-life outcomes.
Results from this study may provide information to guide the design of future, larger clinical trials and may contribute to the evidence base concerning accessible movement and mind-body approaches for individuals living with lipedema.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Cynthia L Beers, Principal Investigator, MS 500ERYT
- Puhelinnumero: 717-571-4610
- Sähköposti: cindy@cindybeers.com
Tutki yhteystietojen varmuuskopiointi
- Nimi: Leslyn Keith, OTD
- Puhelinnumero: 805-748-6519
- Sähköposti: leslynkeithot@gmail.com
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
-
Participants must meet all of the following criteria:
- Be designated female at birth.
- Be at least 18 years of age.
- Have a formal diagnosis of lipedema.
- Meet the eligibility screening requirements based on the framework for research case definitions of lipedema proposed by Keith et al. (2024).
- Be able to read, speak, and understand English.
- Have access to the internet to participate in the remotely delivered study activities.
Exclusion Criteria:
Individuals will be excluded from enrollment if they meet any of the following criteria:
- Have a cardiovascular condition or have undergone surgery within the previous 6 weeks for which exercise is contraindicated without physician clearance.
- Have an active infection.
- Have an untreated deep vein thrombosis (DVT).
- Have a high-risk pregnancy.
- Have cognitive or psychiatric disabilities that prevent the individual from providing informed consent.
- Have a diagnosed serious mental health condition.
- Have experienced a recent major life crisis.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: Mind-Body Chair Yoga + Support Group
Participants assigned to the experimental arm will receive a remotely delivered mind-body chair yoga intervention in addition to participation in the scheduled support group. The chair yoga program will incorporate gentle, adaptable chair-based yoga movements along with breathing practices, relaxation, meditation, and other accessible mind-body practices. The intervention is designed for individuals with varying levels of mobility and can be modified according to individual abilities. Participants will participate in the intervention during the primary study period and will also have access to the support group provided as part of the study. |
A remotely delivered, six-week mind-body chair yoga program designed for individuals with lipedema. The intervention incorporates gentle, adaptable chair-based yoga movements, breathing practices, guided meditation, relaxation, and other accessible mind-body practices. Sessions are designed to accommodate participants with varying levels of mobility and physical ability, with movements modified as needed. The program aims to support functional mobility and quality of life. Participants assigned to this intervention will also participate in the study's scheduled support group. |
|
Active Comparator: Support Group Only
Participants assigned to the active comparator arm will participate in the scheduled remote support group during the primary study period without receiving the mind-body chair yoga intervention. The support group will provide opportunities for participant interaction, discussion, encouragement, and shared experiences related to living with lipedema. Following completion of the primary study period and outcome assessments, participants in this arm will be offered the opportunity to participate in the mind-body chair yoga program. |
A remotely delivered support group for individuals with lipedema. Sessions provide opportunities for participants to share experiences, discuss challenges associated with living with lipedema, exchange coping strategies, and receive peer encouragement in a supportive group environment. The support group is intended to provide social connection and participant engagement throughout the study period. Participants assigned to the support-group-only arm will not receive the mind-body chair yoga intervention during the primary study period. Following completion of the primary study period and outcome assessments, these participants will be offered the opportunity to participate in the mind-body chair yoga program. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Feasibility of the Remote Mind-Body Chair Yoga Intervention
Aikaikkuna: Baseline to immediately post-intervention (7 weeks) and 3-month follow-up.
|
Feasibility will be assessed using recruitment, retention, adherence, intervention completion, and participant acceptability measures. Recruitment feasibility: number/percentage enrolled relative to those screened Retention: percentage completing the 7-week intervention Adherence: attendance and/or completion of prescribed sessions Intervention acceptability: participant ratings of satisfaction or acceptability will be measured using the Participant Program Acceptability Questionnaire. Scale is 1-5. 1= Strongly Disagree, 5 = Strongly Agree. Study completion: percentage completing baseline and post-intervention assessments Adverse events: number and type of events related to the intervention. This is measured by Post Class Check-In and Weekly Check-In. |
Baseline to immediately post-intervention (7 weeks) and 3-month follow-up.
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change in Functional Mobility from Baseline to Post-Intervention
Aikaikkuna: Baseline to immediately post-intervention (7 weeks) and 3-month follow-up.
|
Functional mobility will be assessed at baseline and post-intervention using the: Lower Extremity Functional Scale (LEFS) - Scale is 0-4. 0=Extreme Difficulty or Unable to Perform Activity. 4=No Difficulty Upper Extremity Functional Index (UEFI) - Scale is 0-4. 0=Extreme Difficulty or Unable to Perform Activity. 4=No Difficulty 30 Second Chair Stand Assessment - There is no rating for this. This is rated based on the number of chair-to-standing transitions within 30 seconds. The change in functional mobility from baseline to post-intervention will be compared between participants assigned to the mind-body chair yoga plus support group and those assigned to the support-group-only comparison group. |
Baseline to immediately post-intervention (7 weeks) and 3-month follow-up.
|
|
Change in Mental Well-Being from Baseline to Post-Intervention
Aikaikkuna: Baseline to immediately post-intervention (7 weeks) and 3-month follow-up.
|
Change in mental well-being will be assessed using the Lipedema Psychological Functioning Questionnaire in the study protocol. Scale is: 0-6. 0=Never, 6=Always Scores collected at baseline and post-intervention will be compared between the two study groups. |
Baseline to immediately post-intervention (7 weeks) and 3-month follow-up.
|
|
Change in Pain Severity from Baseline to Post-Intervention
Aikaikkuna: Baseline to immediately post-intervention (7 weeks) and 3-month follow-up.
|
Change in pain severity will be assessed using the Brief Pain Inventory. Scale is: 0 to 10 (depends on the question). Different options for zero can be no pain, no relief, or does not interfere. Ten equals pain as bad you can imagine, complete relief, or completely interferes. This is specified in the study protocol. Baseline and post-intervention scores will be compared between the two study groups. |
Baseline to immediately post-intervention (7 weeks) and 3-month follow-up.
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Cynthia L Beers, MS
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network. Phys Ther. 1999 Apr;79(4):371-83.
- Clarke C, Kirby JN, Smidt T, Best T. Stages of lipoedema: experiences of physical and mental health and health care. Qual Life Res. 2023 Jan;32(1):127-137. doi: 10.1007/s11136-022-03216-w. Epub 2022 Aug 16.
- Herbst KL, Kahn LA, Iker E, Ehrlich C, Wright T, McHutchison L, Schwartz J, Sleigh M, Donahue PM, Lisson KH, Faris T, Miller J, Lontok E, Schwartz MS, Dean SM, Bartholomew JR, Armour P, Correa-Perez M, Pennings N, Wallace EL, Larson E. Standard of care for lipedema in the United States. Phlebology. 2021 Dec;36(10):779-796. doi: 10.1177/02683555211015887. Epub 2021 May 28.
- Mortimer PS, Rockson SG. New developments in clinical aspects of lymphatic disease. J Clin Invest. 2014 Mar;124(3):915-21. doi: 10.1172/JCI71608. Epub 2014 Mar 3.
- Ghods M, Georgiou I, Schmidt J, Kruppa P. Disease progression and comorbidities in lipedema patients: A 10-year retrospective analysis. Dermatol Ther. 2020 Nov;33(6):e14534. doi: 10.1111/dth.14534. Epub 2020 Nov 22.
- 13. Stephens, I. (2017). Medical yoga therapy. Children, 4(2), 12.
- Simarro JL, Michelini S, Andres-Gasco M, Lebrero Garcia A, Ortega Abad D, Margalejo Lombardo J, Buj Vargas J, Sanchez-Costa JT, Martin Martinez MA. Clinical Signs at Diagnosis and Comorbidities in a Large Cohort of Patients with Lipedema in Spain. Biomedicines. 2025 Dec 11;13(12):3049. doi: 10.3390/biomedicines13123049.
- Kunzova M, Lagova E, Keith L. Mental and physical health burden and quality of life in Czech women with lipedema. Front Glob Womens Health. 2025 Jul 24;6:1629077. doi: 10.3389/fgwh.2025.1629077. eCollection 2025.
- 9. Kuhn, A. L. (2026). Accessible Mind-Body Movement Therapies for Low Back Pain Management. The Journal for Nurse Practitioners, 22(6), 93-105, https://doi.org/10.1016/j.nurpra.2026.105788.
- Keith L, Seo C, Wahi MM, Huggins S, Carmody M, Faerber G, Forner-Cordero I, Michelini S, Rapprich S, Rockson SG. Proposed Framework for Research Case Definitions of Lipedema. Lymphat Res Biol. 2024 Apr;22(2):93-105. doi: 10.1089/lrb.2023.0062. Epub 2024 Mar 28.
- Hakim AJ, Grahame R. A simple questionnaire to detect hypermobility: an adjunct to the assessment of patients with diffuse musculoskeletal pain. Int J Clin Pract. 2003 Apr;57(3):163-6.
- 4. Executive Committee of the International Society of Lymphology. (2020). The diagnosis and treatment of peripheral lymphedema: 2020 consensus document of the International Society of Lymphology. Lymphology, 53, 3-19.
- Dudek JE, Bialaszek W, Ostaszewski P. Quality of life in women with lipoedema: a contextual behavioral approach. Qual Life Res. 2016 Feb;25(2):401-408. doi: 10.1007/s11136-015-1080-x. Epub 2015 Jul 28.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- MBY-LIP-MOB-2027-01
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
Individual participant data will not be shared with other researchers because the study involves sensitive health-related information, including information about lipedema symptoms, functional mobility, and mental well-being. To protect participant privacy and confidentiality, individual-level data will be accessible only to authorized study personnel and managed in accordance with the study's approved data security procedures and informed consent. Study findings may be disseminated through publications, presentations, and other scholarly communications using aggregate or summary data that do not identify individual participants.
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