Effects of Intradialytic Cognitive and Physical Exercise Training on Functional Status of Hemodialysis Patients (DIAKOG)

University Medical Centre Ljubljana

Status: Completed

Conditions: Chronic Kidney Diseases; Physical Inactivity; Cognitive Dysfunction

Treatments: Other: Cognitive and physical exercise training

Study type: Interventional

Funder types: Other

Identifiers

NCT05150444

Z3-3212

Details and patient eligibility

About

The aim of this study is to investigate the effect of cognitive training combined with physical exercise on cognitive function, physical performance and frailty indicators in the hemodialysis population.

Full description

The prevalence of cognitive impairment in hemodialysis (HD) patients is extremely high. Despite the well-documented benefits of interventions on cognitive function, there is a widespread call for effective strategies that will show the long-term consequences in patients undergoing dialysis. A randomized controlled intervention trial to examine the effects of a combined non-pharmacological intervention in the form of intradialytic physical exercise and intradialytic cognitive training on cognitive function, indicators of frailty, and physical performance measures in HD patients will be conducted. The group of patients receiving the study intervention will be compared to the control group receiving standard HD care. The duration of the intervention will be 12 weeks (3 days a week). We will use sensitive instruments (cognitive domain tests) to assess cognitive functions. The primary outcome of the study at 12 weeks will be performance on the Alertness subtest of the computerized Test of Attentional Performance. Secondary study outcomes will be: Performance in other domains of cognitive function (executive function, psychomotor speed, information processing efficiency, working memory, attention), physical fitness (10 repetition sit-to-stand test, timed up and go test, handgrip strength test, spontaneous gait speed, Stork balance test), and assessment of frailty (Edmonton Frail Scale). Study outcomes will be assessed at baseline and immediately after the 12-week intervention. This study will be among the first to test the synergistic effects of a uniquely designed physical exercise and cognitive training intervention on functional status in HD patients.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• dialysis patients on renal replacement therapy with chronic hemodialysis
• duration of hemodialysis treatment for at least 3 months
• capable of independent walking and independent feeding

Exclusion criteria

• the presence of chronic malignant or infectious disease
• uncontrolled arterial hypertension with an average of the last five pre-dialysis blood pressure values above 180/100 mm Hg,
• unstable angina pectoris or Canadian Cardiovascular Society class 2-4,
• heart failure New York Heart Association class 3 and 4,
• the presence of a psychotic illness or a mental disability,
• a condition with an amputated limb (more than 2 fingers on the lower limb and / or more than 2 fingers on the upper limb)
• any other condition that causes the clinical unstability of the patient (i.e. repetitive gastrointestinal hemorrhagies, liver cirrhosis with frequent exacerbations)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 2 patient groups

Cognitive and physical exercise training

Experimental group

Description:

This group will perform combined intradialytic cognitive and physical exercise training. First, they will exercise during dialysis (3 times a week; 12 weeks) for \~30 minutes on a customized ergometer. They will start with a 3-min warm-up, then the resistance will be implied to each individual according to the rate of perceived exertion of 4th to 5th grade on a 10-grade Borg scale. After a break, they will be given tablet computers in order to play "brain games" on a CogniFit platform (\~30 - 45 min).

Treatment:

Other: Cognitive and physical exercise training

Standard care

No Intervention group

Description:

This group will receive standard hemodialysis care.