NCT05166486

Brief Summary

The aimed this study is to examine the effects of calisthenic exercises on aerobic capacities, muscle strength and quality of life in patients receiving hemodialysis treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2021

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 25, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 22, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2023

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

1.4 years

First QC Date

November 25, 2021

Last Update Submit

May 9, 2023

Conditions

Keywords

ExerciseHemodialysisQuality of life

Outcome Measures

Primary Outcomes (5)

  • Demographic Information Form

    In the form prepared by the researchers with the support of the literature, there are questions about the socio-demographic characteristics of the participants such as gender, age, height, weight, educational status, how long they have been on dialysis, etc.

    immediately after application

  • 6 Min. Walking Test

    It is a test method used for the Evaluation of Cardiovascular Endurance. The 6 Minute Walk Test (6MWT) is among the field tests among the cardiopulmonary exercise tests. The test has been proven to be safe, inexpensive and easy to apply. The six-minute walk test is a test that aims to evaluate the submaximal functional capacity by measuring the distance that patients can walk quickly on a hard flat surface in a 6-minute period, in a corridor varying between 30 m and 50 m in length. The 6 MWT is a submaximal exercise test, but correlates well with the maximal cardiovascular exercise test and is better tolerated than other walking tests and better reflects activities of daily living.

    immediately after application

  • 30 sec Sit and Stand Test

    30-second sit-stand test to evaluate the dynamic balance and physical fitness lower extremity neuromuscular function levels of individuals It is applied. The test is started while the individual sits in an armless chair, approximately 43 cm high from the ground, in an upright position, with the feet in contact with the ground, with the arms crossed in front of the chest. After the start command is given to the individual, they are asked to come to the standing upright position and again to the sitting position from the determined position for 30 seconds. The number of complete take-offs completed by the individual for 30 seconds is determined.

    immediately after application

  • Grip Force Measurement with Hand Held Dynamometer

    The Jamar Dynamometer is the best known of such devices. During measurements, the hand is in the claw grip position, except for flexion at the metacarpophalangeal joints. The handle part can be adjusted to 5 different levels according to the size of the hand. The Jamar Dynamometer is the most widely used and most reliable grip strength measuring instrument.

    immediately after application

  • Kidney Disease Quality of Life Questionnaire

    This scale is a scale that is used to monitor patients with end-stage rtreatment effects and well-being by self-declaring. assesses quality of life on 8 generics (physical function, role limitations due to social problems, bodily pain, general health, social function, role limitations due to physical problems, energy and fatigue, mental health) and 12 disease-specifi c subscales (effects of kidney disease, symptom list, work status, burden of kidney disease, cognitive function, sexual function, quality of life social interaction, sleep, social support, dialysis staff encouragement, overall health, patient satisfaction). Each subscale is scored out of 100, with higher score indicating greater perceived health al diseasene and evaluates various

    immediately after application

Study Arms (2)

Calisthenic exercise

EXPERIMENTAL

The patients in the calisthenic exercise group will be given one-to-one hands-on calisthenic exercises by the research physiotherapist. They will be asked to do these exercises 3 times a week for 8 weeks. Patients will be followed up by asking whether they do their exercises or not. They will be asked to do the exercises twice a month for 8 weeks under the control of a physiotherapist. In this way, it will be ensured that the exercises are done correctly and that the patients do it completely.

Other: Calisthenic exercise

Control

NO INTERVENTION

Control

Interventions

Exercises involving major muscle groups will be given. Before starting the calisthenic exercises, they will be asked to perform 10 repetitive warm-ups and breathing exercises. The intensity of the calisthenic exercises will be adjusted on a weekly basis. Calisthenic exercises are repeated 10-15 times in the first and second weeks; third and fourth weeks 15-20 repetitive; In the five, six, seven and eight weeks, it will be done with 25-30 repetitions. Patients will be asked to keep an exercise diary and weekly follow-ups will be made over the phone. Within eight weeks, each patient will come for control twice a month and will be asked to perform the exercises individually under the supervision of a physiotherapist. Patients will be asked to do the exercises three times a week for 8 weeks.

Calisthenic exercise

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Being treated in the Hemodialysis unit of Aydın Adnan Menderes University Faculty of Medicine Research and Application Hospital,
  • Having good cognitive functions
  • Not having regular exercise habits
  • Not having a physical disability
  • Being between 18-60 years old
  • Speaking and understanding Turkish
  • Being willing to participate in the study

You may not qualify if:

  • Neurologically affected patients (such as cerebrovascular accident, Gullian Barre)
  • Patients with musculoskeletal problems that prevent exercise
  • Patients with advanced heart failure, patients with unstable angina pectoris
  • Patients with chronic liver failure
  • Patients with a history of cardiovascular events (recent within 12 months)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aydın Adnan Menderes University Hospital

Aydin, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Nazan Ozturk, PhD.

    Aydin Adnan Menderes University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 25, 2021

First Posted

December 22, 2021

Study Start

November 15, 2021

Primary Completion

April 15, 2023

Study Completion

April 15, 2023

Last Updated

May 10, 2023

Record last verified: 2023-05

Locations