Impact of Home-Based Aerobic and Resistance Training in Chronic Liver Disease: a Randomized Control Trial

NCT06892366 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2025-03-24

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate whether home-based exercise interventions, including aerobic exercise (AE) and a combination of aerobic and resistance exercise (ARE), can improve physical and health-related outcomes in patients with chronic liver disease (CLD). The primary population includes adult patients with CLD experiencing complications such as sarcopenia, malnutrition, and fatigue.

The main questions it aims to answer are:

Does home-based ARE improve oxygen consumption, muscle strength, and physical frailty more effectively than AE or no exercise? Can home-based exercise reduce fatigue and improve quality of life and health-related behaviors?

Researchers will compare the outcomes of three groups:

Home-based AE group Home-based ARE group Control group (physical activity counselling)

Participants will:

Perform an 8-week home-based exercise program based on their group allocation (either AE or ARE).

Undergo evaluations before and after the intervention, including:

Oxygen consumption (via cardiopulmonary exercise testing) Muscle strength (using a hand dynamometer and respiratory muscle strength tests) Body composition (via bioelectrical impedance analysis and skinfold thickness measurements) Quadriceps muscle thickness and cross-sectional area (using muscle ultrasound) Muscle oxygenation Fatigue levels (using the Fatigue Severity Scale) Physical frailty (using the Liver Frailty Index) Quality of life (using the Chronic Liver Disease Questionnaire) Health-related lifestyle behaviors (using the Health-Promoting Lifestyle Profile II)

Conditions

  • Chronic Liver Disease and Cirrhosis

Interventions

BEHAVIORAL

Home-Based Aerobic Exercise Program

Aerobic Exercise (AE) Group This intervention consists of a home-based aerobic exercise program emphasizing moderate-intensity walking, tailored to 40-60% of peak VO2 or Borg Scale 4-6 for those on beta blockers. Distinctive features include real-time session supervision via video conferencing and heart rate monitoring with a smart wristband. This approach ensures remote guidance, personalized intensity, and participant safety throughout the 8-week program.

BEHAVIORAL

Home-Based Aerobic and Resistance Exercise (ARE) Group

Participants engaged in a combined home-based aerobic and resistance exercise program. Aerobic sessions followed the same protocol as the AE group (3 days/week). Resistance training was performed 2 additional days per week using elastic resistance bands set at 40-50% of one-repetition maximum (1RM). Resistance exercises targeted major muscle groups, with each session consisting of 3 sets of 10 repetitions, and 1-3 minutes of rest between sets. All sessions were monitored and supervised remotely.

Sponsors & Collaborators

  • Hacettepe University

    lead OTHER

Principal Investigators

  • Naciye Vardar Yağlı, Prof · Hacettepe University Faculty of Physical Therapy and Rehabilitation

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-20
Primary Completion
2024-04-16
Completion
2024-06-16

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06892366 on ClinicalTrials.gov