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

NCT05150444 | Completed

• 1 other identifier: Z3-3212
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cognitive Dysfunction; Physical Inactivity; Chronic Kidney Diseases

Keywords

cognitive functions; hemodialysis; physical activity; intradialytic training; non-pharmacological interventions

Outcome Measures

Primary Outcomes (1)

• Change in Test of Attentional Performance (TAP) score

  The Test of Attentional Performance (TAP) is a software package that can be used primarily to examine attention functions. The rationale for the selection of the main outcome: low learning effect, most probably affected by physical exercise, attention is one of the most affected cognitive domains in dialysis patients. From the TAP test battery, subtests Alertness, Selective attention, and Divided attention will be included.

  baseline, after 12 weeks

Secondary Outcomes (24)

• Change in Montreal Cognitive Assessment (MoCA) score

  baseline, after 12 weeks

• Change in Trail Making Test A and B score

  baseline, after 12 weeks

• Change in Symbol Digit Modalities Test (SDMT) score

  baseline, after 12 weeks

• Change in 10 repetition sit-to-stand test time

  baseline, after 12 weeks

• Change in Stork balance test time

  baseline, after 12 weeks

Study Arms (2)

Cognitive and physical exercise training

EXPERIMENTAL

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).

Other: Cognitive and physical exercise training

Standard care

NO INTERVENTION

This group will receive standard hemodialysis care.

Interventions

Cognitive and physical exercise training OTHER

12 weeks (3 times a week): patients will cycle on an adapted ergometer during their dialysis procedure. The exercise program will be run by kinesiologists. Participants will start with 15 minutes of cycling and then gradually increase the time and intensity. After the physical exercise session, they will continue with cognitive training. This training will be done on a tablet computer on a CogniFit platform (\~30 minutes). The "brain games" on mentioned platform automatically adapt to individual cognitive abilities.

Cognitive and physical exercise training

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Centre

Ljubljana, Osrednjeslovenska, 1000, Slovenia

Location

Related Publications (1)

• Bogataj S, Trajkovic N, Pajek M, Pajek J. Effects of Intradialytic Cognitive and Physical Exercise Training on Cognitive and Physical Abilities in Hemodialysis Patients: Study Protocol for a Randomized Controlled Trial. Front Psychol. 2022 Jan 25;13:835486. doi: 10.3389/fpsyg.2022.835486. eCollection 2022.

  PMID: 35145465 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Sedentary Behavior; Renal Insufficiency, Chronic; Motor Activity

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavior; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jadranka Buturović Ponikvar, PhD

  University Medical Centre Ljubljana

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Researcher

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: December 9, 2021
• Study Start: November 2, 2022
• Primary Completion: January 25, 2023
• Study Completion: June 30, 2023
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)