Blood Flow Restriction Training in Chronic Heart Failure: an Effective Training Strategy?

NCT03342833 | Completed Phase 2

• 1 other identifier: 17.YH.0348
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this current study proposal is to identify the potential physiological adaptations arising from a combined BFR+HIIT training intervention in CHF patients. We hypothesise that the addition of BFR to HIIT will increase whole-body V̇O2peak by promoting vascular and skeletal muscle adaptations above that seen with HIIT alone. The secondary outcomes of this study are to determine if such a training intervention leads to clinical improvements in exercise intolerance symptoms and quality of life indices. Given that the majority of previous research in to both BFR and HIIT has largely involved young, healthy and relatively active participants, the final objective of this current proposal is to determine the viability, tolerability and efficacy of these training modalities in an elderly cohort of predominantly sedentary CHF patients.

Conditions

Chronic Heart Failure

Outcome Measures

Primary Outcomes (1)

• Peak oxygen consumption (ml.kg.min)

  Peak oxygen consumption

  4 weeks

Secondary Outcomes (1)

• Quality of life (points)

  4 weeks

Study Arms (2)

Blood flow restriction

ACTIVE COMPARATOR

Device: Blood flow restriction

Usual training

SHAM COMPARATOR

Device: Blood flow restriction

Interventions

Blood flow restriction DEVICE

Occlusion of venous flow between bouts of HIIT training exercise

Blood flow restriction; Usual training

Eligibility Criteria

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

You may qualify if:

• Patients with New York Heart Association (NYHA) class II-III symptoms Stable CHF of at least 3 months duration On optimally tolerated medication for CHF No contraindications for cycling exercise Able and willing to give informed consent

You may not qualify if:

• Class IV CHF Any contraindications to exercise Significant COPD (FEV1\<60%), severe renal disease (eGFR\<30), primary pulmonary hypertension as a co-morbidity Unable to give informed consent Current diagnosis of active cancer, inflammatory or musculoskeletal disease (e.g. rheumatoid arthritis), on-going infection or sepsis.

Sponsors & Collaborators

• University of Leeds: lead

Study Sites (1)

Leeds Teaching Hospitals NHS Trust

Leeds, West Yorkshire, LS16 5AR, United Kingdom

Location

MeSH Terms

Interventions

Blood Flow Restriction Therapy

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer in Cardiology

Study Record Dates

• First Submitted: November 7, 2017
• First Posted: November 17, 2017
• Study Start: March 10, 2018
• Primary Completion: January 1, 2021
• Study Completion: April 1, 2021
• Last Updated: April 30, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR

Locations

GB (1)