- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02753868
Acute Effects of Intradialytic Exercise on Cardiovascular Function in Hemodialysis Patients (ACE-HD)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Patients with kidney failure requiring hemodialysis (HD) treatment die at excessively high rates, despite advances in HD techniques and pharmacological therapies. This indicates additional therapeutic strategies are needed. Intradialytic exercise (IDEX, exercise during HD treatment) represents a low-cost, easy to administer treatment strategy that could potentially improve cardiovascular function, physical function and quality of life. However, nephrologists rarely counsel their patients to increase their physical activity levels or to exercise during HD treatment, in part due to a lack of understanding of IDEX knowledge.
Providing more robust evidence for the safety and effectiveness of IDEX, as well as evaluating the impact of exercising early vs late in the treatment, could help improve adoption of exercise training as a standard practice in HD clinics.
Therefore, investigators plan to examine the impact of IDEX and its timing during treatment (1st vs 3rd hour) on blood pressure and adverse symptoms in HD patients. The proposed study also includes various cardiovascular measures to allow deeper mechanistic understanding of cardiovascular physiology with IDEX. Such understanding will significantly advance the field and lead to improved therapeutic approaches, including exercise training, which may help mediate the deleterious effects of renal failure.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Illinois
-
Urbana, Illinois, Forenede Stater, 61801
- University of Illinois at Urbana-Champaign
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Receiving hemodialysis treatment three times per week, on hemodialysis for greater than three months, receive medical clearance from a Nephrologists
Exclusion Criteria:
- Patients with established contraindications to exercise including lower-limb amputation, advanced chronic obstructive pulmonary disease and decompensated chronic heart failure.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Standard Hemodialysis
Participants will be monitored during their normal hemodialysis treatment with no intervention administered
|
Participants will receive a standard hemodialysis treatment during the study period
|
Eksperimentel: Hemodialysis with Exercise (1-st hr)
Participants will be monitored during a normal dialysis treatment in which they cycle at mild to moderate intensity for 30 minutes during 1-st hour into treatment
|
Participants will receive a standard hemodialysis treatment during the study period
Participants will be asked to cycle at mild to moderate intensity for 30 minutes during either 1-st hour of 3-rd hour into treatment
|
Eksperimentel: Hemodialysis with Exercise (3-rd hr)
Participants will be monitored during a normal dialysis treatment in which they cycle at mild to moderate intensity for 30 minutes during 3-rd hour into treatment
|
Participants will receive a standard hemodialysis treatment during the study period
Participants will be asked to cycle at mild to moderate intensity for 30 minutes during either 1-st hour of 3-rd hour into treatment
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Serial change in brachial blood pressure (mmHg) from start to end of a dialysis treatment
Tidsramme: Every 15 minutes throughout each dialysis treatment (approximately 4 hours)
|
Systolic and diastolic blood pressure will be measured using an automated blood pressure cuff attached to the clinic dialysis machine
|
Every 15 minutes throughout each dialysis treatment (approximately 4 hours)
|
Changes in cardiac output (mL/min) measured by thoracic impedance technique
Tidsramme: Continous throughout a dialysis treatment (approximately 4 hours)
|
Cardiac output will be estimated continuously using thoracic impedance with electrodes placed around the chest.
|
Continous throughout a dialysis treatment (approximately 4 hours)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Changes in total peripheral resistance estimated by peripheral blood pressure via a finger plethysmography and cardiac output via thoracic impedance (Task Force Monitor)
Tidsramme: Continuous throughout each dialysis treatment (approximately 4 hours) for three dialysis sessions that are separated by a week
|
A finger cuff will be placed around the non-dialyzing finger and will measure the change in peripheral blood pressure from successive beats continuously.
Total peripheral resistance will be estimated using measured cardiac output and peripheral blood pressure.
|
Continuous throughout each dialysis treatment (approximately 4 hours) for three dialysis sessions that are separated by a week
|
Hypotensive event assessment measured by a symptom questionnaire
Tidsramme: Throughout and up to 5 hours after completion of a dialysis treatment
|
The presence of hypotensive-relating intradialytic symptoms including nausea, dizziness and cramping will be recorded.
|
Throughout and up to 5 hours after completion of a dialysis treatment
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Kenneth Wilund, PhD, University of Illinois at Urbana-Champaign
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 15691
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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