Physical ActivityNCT03334123
Effects of Exercise and Exercise Counselling in Hemodialysis Patients.
A study testing Functional training and cycling and Cycling in people with Physical Activity and Kidney Diseases, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
The aim of the study is to determine the effect of functional exercise and training counseling by kinesiotherapist in addition to the basic exercise program of cycling during dialysis on physical performance of dialysis patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Physical Activity, Kidney Diseases, Kidney Failure
- What is being tested?
- Functional training and cycling and Cycling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteSlovenia
- Study dates
- 8 Nov 2017to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- dialysis patients on renal replacement therapy with chronic hemodialysis,
- duration of hemodialysis treatment for at least 3 months,
- age 18-90 years,
- capable of independent walking and independent feeding.
Who cannot join
- 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 hemmorrhagies, liver cirrhosis with frequent exacerbations, advanced dementia with poor cooperation of the patient)
Trial locations and contacts
1 site in 1 country.
Slovenia1 site, 1 recruiting
- Recruiting
University Medical Centre
Ljubljana
Jernej Pajek, PhD
About this study
Official title: Effects of Exercise and Exercise Counselling in Hemodialysis Patients: a Randomized Controlled Trial.
The aim of the study is to determine the effect of functional exercise and training counseling by kinesiotherapist in addition to the basic exercise program of cycling during dialysis on physical performance of dialysis patients.
Read the detailed description
Study will include 86 dialysis patients. Investigators will first test the strength of lower limbs with sit-to-stand test, handgrip strength, flexibility, balance, submaximal aerobic capacity, physical characteristics and clinical parameters. After that randomization of patients in two groups will be made - one experimental and one active control group. Patients who will refuse to exercise will be invited to a non-randomized inactive control group (without exercise).
The experimental group will attend 3 times weekly a guided functional exercise before the dialysis procedure for 20 minutes and perform a cycling session during dialysis in the first phase of the study, which will last for 8 weeks. During this time experimental group will receive exercise counselling; instructions how to practice at home will be given by examples and training during functional exercise predialysis sessions.
In the second phase of the study for additional eight weeks participants will be instructed to exercise at home using the skills mastered during the first study phase on non-dialysis days, and continue with the program of intradialysis cycling. Investigators will give them advice, monitor and motivate them.
The active control group will perform intradialytic exercise (intradialysis cycling equal to cycling program of experimental group) during dialysis procedure for four months.
The primary end-point of the study is a change in the 10-repetition sit-to-stand test time as a measure of strength of lower extremities.
Exercise program will be run by a kinesiologist. Main hypothesis is that the guided functional exercise under the surveillance of a kinesiologist added to intradialysis cycling program statistically significantly improves patient's physical performance as compared to the program of intradialysis cycling alone.
- Conditions
- Physical Activity, Kidney Diseases, Kidney Failure, Chronic Kidney Diseases, End Stage Renal Disease
- Being tested
- Functional training and cycling, Cycling
- Keywords
- exercise, aerobic exercise, functional training, strength training, resistance training, kidney failure, rehabilitation, physical activity, hemodialysis, dialysis patients, chronic renal failure, chronic kidney disease, end-stage renal disease, intradialytic exercise
- Medical subject headings
- Motor Activity, Kidney Diseases, Renal Insufficiency, Renal Insufficiency, Chronic, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional training and cyclingOther
Also called Functional training, intradialysis cycling and counselling, Experimental group
First 8 weeks: patients will perform 20 minutes of functional training before their dialysis procedure. The exercise program will be run by kinesiologists, who will also teach patients how to perform exercises on their own at home. During intradialysis cycling 3 times weekly participants will cycle on adapted ergometer. Participants will start with 10 - 15 minutes of cycling and then gradually increase time and intensity up to 45 minutes of duration.
Second phase of 8 weeks: participants will no longer perform functional training before dialysis but will be motivated, monitored and advised to perform functional exercise at home on non-dialysis days for 20-30 minutes and continue with cycling sessions during the dialysis procedures three times weekly.
CyclingOther
Also called Intradialysis cycling exercise, Active control group
First 8 weeks: cycling on an adapted ergometer during dialysis; starting with 10 - 15 minutes of cycling and then gradually increasing time and intensity up to 45 minutes of duration.
Second 8 weeks: continue with cycling at the target duration and intensity during dialysis.
| Study group | Role | What they receive |
|---|---|---|
| Functional training and cycling | Experimental | Participants in this group will perform 20 minutes of functional training before dialysis (in the first 8 weeks) and intradialysis cycling exercise during dialysis. Participants will also receive exercise counselling; investigators will teach them how to practice at home by practice and examples given during the 20 minutes of functional training pre-dialysis. In the second phase of additional eight weeks participants will perform the functional training at home on non-dialysis days in addition to intradialysis cycling. Kinesiologist will monitor, advice and motivate them. Receives: Other: Functional training and cycling |
| Cycling | Active comparator | This active control comparator group will perform intradialytic cycling on an adapted ergometer 3 times per week for 4 months without functional training prior to dialysis procedure and without exercise counselling. Receives: Other: Cycling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 10 repetition sit-to-stand test time
Performance of the sit-to-stand test involves activation of the lower limb muscles; the test measures lower limb strength. Participants are required to 10 times stand up from and sit down on an armless chair as quickly as possible. Their arms should be folded across their chest.
Measured: baseline, 8 weeks and 16 weeks
Secondary outcomes (5)
Change in 6-minute walk test distance
Distance made in 6-minute walk test (submaximal aerobic endurance)
Measured: baseline, 8 weeks and 16 weeks
Change in lean and fat body mass
Body composition measurements by bioimpedance
Measured: baseline, 8 weeks and 16 weeks
Change in serum interleukin-6 (IL-6)
Predialysis serum concentration of IL-6 as a measure of inflammation
Measured: baseline, 8 weeks and 16 weeks
Change in Stork balance test time
Stork balance test time as a measure of balance
Measured: baseline, 8 weeks, 16 weeks
Change in sit-and-reach test distance
Sit-and-reach test distance as a measure of flexibility
Measured: baseline, 8 weeks, 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start8 Nov 2017
- Primary completion1 Apr 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- Slovenian Research Agency
- Responsible party
- Principal investigator, Jernej Pajek, University Medical Centre Ljubljana
- Investigators
- Jadranka Buturović Ponikvar, MD, PhD, Study chair, UMC Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03334123
- Sponsor's protocol ID
- DIAGIBII
- Status last verified
- May 2018
- First submitted
- 10 Oct 2017
- Last updated
- 11 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653.
PubMed 35018639Bogataj S, Pajek J, Buturovic Ponikvar J, Pajek M. Functional training added to intradialytic cycling lowers low-density lipoprotein cholesterol and improves dialysis adequacy: a randomized controlled trial. BMC Nephrol. 2020 Aug 18;21(1):352. doi: 10.1186/s12882-020-02021-2.
PubMed 32811448
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise and Exercise Counselling in Hemodialysis Patients: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03334123
- Acronym / sponsor ID
- DIAGIBII
- Conditions
- Physical Activity, Kidney Diseases, Kidney Failure, Chronic Kidney Diseases, End Stage Renal Disease
- Keywords
- exercise, aerobic exercise, functional training, strength training, resistance training, kidney failure, rehabilitation, physical activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Collaborators
- Slovenian Research Agency
- Study start
- 8 Nov 2017 (actual)
- Primary completion
- 1 Apr 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 7 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to determine the effect of functional exercise and training counseling by kinesiotherapist in addition to the basic exercise program of cycling during dialysis on physical performance of dialysis patients.
Detailed description
Study will include 86 dialysis patients. Investigators will first test the strength of lower limbs with sit-to-stand test, handgrip strength, flexibility, balance, submaximal aerobic capacity, physical characteristics and clinical parameters. After that randomization of patients in two groups will be made - one experimental and one active control group. Patients who will refuse to exercise will be invited to a non-randomized inactive control group (without exercise).
The experimental group will attend 3 times weekly a guided functional exercise before the dialysis procedure for 20 minutes and perform a cycling session during dialysis in the first phase of the study, which will last for 8 weeks. During this time experimental group will receive exercise counselling; instructions how to practice at home will be given by examples and training during functional exercise predialysis sessions.
In the second phase of the study for additional eight weeks participants will be instructed to exercise at home using the skills mastered during the first study phase on non-dialysis days, and continue with the program of intradialysis cycling. Investigators will give them advice, monitor and motivate them.
The active control group will perform intradialytic exercise (intradialysis cycling equal to cycling program of experimental group) during dialysis procedure for four months.
The primary end-point of the study is a change in the 10-repetition sit-to-stand test time as a measure of strength of lower extremities.
Exercise program will be run by a kinesiologist. Main hypothesis is that the guided functional exercise under the surveillance of a kinesiologist added to intradialysis cycling program statistically significantly improves patient's physical performance as compared to the program of intradialysis cycling alone.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional training and cycling | Experimental | Other: Functional training and cyclingParticipants in this group will perform 20 minutes of functional training before dialysis (in the first 8 weeks) and intradialysis cycling exercise during dialysis. Participants will also receive exercise counselling; investigators will teach them how to practice at home by practice and examples given during the 20 minutes of functional training pre-dialysis. In the second phase of additional eight weeks participants will perform the functional training at home on non-dialysis days in addition to intradialysis cycling. Kinesiologist will monitor, advice and motivate them. |
| Cycling | Active comparator | Other: CyclingThis active control comparator group will perform intradialytic cycling on an adapted ergometer 3 times per week for 4 months without functional training prior to dialysis procedure and without exercise counselling. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- dialysis patients on renal replacement therapy with chronic hemodialysis,
- duration of hemodialysis treatment for at least 3 months,
- age 18-90 years,
- capable of independent walking and independent feeding.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional training and cyclingAlso: Functional training, intradialysis cycling and counselling, Experimental groupFirst 8 weeks: patients will perform 20 minutes of functional training before their dialysis procedure. The exercise program will be run by kinesiologists, who will also teach patients how to perform exercises on their own at home. During intradialysis cycling 3 times weekly participants will cycle on adapted ergometer. Participants will start with 10 - 15 minutes of cycling and then gradually increase time and intensity up to 45 minutes of duration. Second phase of 8 weeks: participants will no longer perform functional training before dialysis but will be motivated, monitored and advised to perform functional exercise at home on non-dialysis days for 20-30 minutes and continue with cycling sessions during the dialysis procedures three times weekly. | Other | Functional training and cycling |
| CyclingAlso: Intradialysis cycling exercise, Active control groupFirst 8 weeks: cycling on an adapted ergometer during dialysis; starting with 10 - 15 minutes of cycling and then gradually increasing time and intensity up to 45 minutes of duration. Second 8 weeks: continue with cycling at the target duration and intensity during dialysis. | Other | Cycling |
Primary outcome
Change in 10 repetition sit-to-stand test time
Time frame: baseline, 8 weeks and 16 weeks
Performance of the sit-to-stand test involves activation of the lower limb muscles; the test measures lower limb strength. Participants are required to 10 times stand up from and sit down on an armless chair as quickly as possible. Their arms should be folded across their chest.
5 secondary outcomes
Change in 6-minute walk test distance
Time frame: baseline, 8 weeks and 16 weeks
Change in lean and fat body mass
Time frame: baseline, 8 weeks and 16 weeks
Change in serum interleukin-6 (IL-6)
Time frame: baseline, 8 weeks and 16 weeks
Change in Stork balance test time
Time frame: baseline, 8 weeks, 16 weeks
Change in sit-and-reach test distance
Time frame: baseline, 8 weeks, 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Derived from this study: PubMed 35018639Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653.
- Derived from this study: PubMed 32811448Bogataj S, Pajek J, Buturovic Ponikvar J, Pajek M. Functional training added to intradialytic cycling lowers low-density lipoprotein cholesterol and improves dialysis adequacy: a randomized controlled trial. BMC Nephrol. 2020 Aug 18;21(1):352. doi: 10.1186/s12882-020-02021-2.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jadranka Buturović Ponikvar, MD, PhD study chair
UMC Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional training and cycling and Cycling in people with Physical Activity and Kidney Diseases, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jernej Pajek, MD, PhD (+38615225360, jernej.pajek@kclj.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 10 repetition sit-to-stand test time (time frame: baseline, 8 weeks and 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03334123, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2018.