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Kidney Failure, ChronicNCT02908594

Intradialytic Exercises During Hemodialysis

A study testing Medical Exercise Peddler 3000, Medi-Bike, Taiwan in people with Kidney Failure, Chronic, run by Cardinal Tien Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Aim. To investigate the effect of an intradialytic aerobic and resistance cycling exercise program (IARCEP) on depression, fatigue, and quality of life (QOL) in end-stage renal disease (ESRD) patients receiving haemodialysis, and further determine the effect of mediation through self-efficacy and resilience in… Read more about this study

Who is it for?
Ages 24 to 79 years
Conditions the study is for
Kidney Failure, Chronic
What is being tested?
Medical Exercise Peddler 3000, Medi-Bike, Taiwan
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
No sites listed yet
Study dates
Jun 2013to May 2016
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 24 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • older than 20 years
  • provided consent to participate in this study
  • received haemodialysis 3 times per week for least 3 months
  • missed no more than two dialysis sessions in the previous month
  • had an adequate dialysis, counted by Kt / V over 1.2
  • no lower dialysis graft, basic comprehension and communication in Mandarin or Taiwanese
  • on positive response to any of the supplementary questions in the Physical Activity Readiness Questionnaire (PAR-Q).

Who cannot join

  • is currently infection or inflammation, autoimmunity disorders, cerebrovascular accidents in the previous 6 months
  • severe muscle weakness or interfering skeletal deformities on lower limbs
  • history of repeated episodes of hypoglycaemia, cardiopulmonary contraindications to resistance exercise (e.g., myocardial infarction, active angina, and uncompensated congestive heart failure in the previous 6 months)
  • lower limb amputation
  • history of participating regularly in exercise programs over 3 months.

About this study

Official title: Institutional Review Board of the Cardinal Tien Hospital

Aim. To investigate the effect of an intradialytic aerobic and resistance cycling exercise program (IARCEP) on depression, fatigue, and quality of life (QOL) in end-stage renal disease (ESRD) patients receiving haemodialysis, and further determine the effect of mediation through self-efficacy and resilience in patients receiving the IARCEP.

Background. Depression and fatigue are common in ESRD patients undergoing haemodialysis, which negatively affects their QOL. Exercise can mitigate this effect. Patient's self-efficacy and resilience may be crucial mediators in exercise.

Design. This study was a randomised controlled trial. Method. Seventy-six participants were randomly assigned to either a control or exercise group. Both groups received routine care; whereas the exercise group participated the 3- months IARCEP. Data were collected at baseline, the first, second, and third months, over a 14 months in 2013-2014.

Read the detailed description

According to the United States Renal Data System (2015), in 2013, 88.2% of all incident cases of ESRD involved renal replacement therapy with haemodialysis, ESRD is highly prevalent in Taiwan, with 2,902 cases per million people; 89.7% of cases in 2012 involved maintenance haemodialysis treatment as the renal replacement therapy. Patients generally receive haemodialysis 3 days per week, and each session generally takes 4 hr. Beginning dialysis induces multiple physical and psychological stressors in patients. In particular, the importance of intervention programs improving psychosocial function should be noted considering disease and its long-term treatment. High depression and fatigue are crucial for consideration in the global care of dialysis patients because these factors are associated with mortality. A significant correlation exists between reduced physical activity and increased depression or fatigue; with decreased activity, muscle strength decreases, which exacerbates depression and fatigue.

Depression is the most common psychosocial problem observed in ESRD patients undergoing haemodialysis, with a prevalence between 27.9% and 40.2% associated with a high risk of hospitalisation and prolonged hospital stay, reduced quality of life (QOL), decreased adherence to dialysis prescriptions, and increased medical comorbidity.

Fatigue is another critical concern caused by haemodialysis; ESRD patients receiving haemodialysis have reduced red blood cell production, thus causing fatigue, the prevalence of which ranges between 53% and 97%. Fatigue has a negative effect on the physical function, ability to perform daily activities, QOL, and even survival of patients. QOL is the subjective perception of an illness and corresponding treatment regarding physical, psychological, and social well-being; however, QOL serves as a prognostic measure and predictor of survival. ESRD patients receiving haemodialysis have a lower QOL than do other patients with other chronic illnesses and general population. Lower health-related QOL is associated with higher rates of hospitalisation and lower rates of survival among patients undergoing haemodialysis. Therefore, identifying effective interventions to assist ESRD patients receiving haemodialysis in managing their physical, psychological, and social problems is critical.

Regular exercise could improve general health in many chronically ill patients. Planned exercise programs are nonpharmacological interventions that can safely and effectively improve depression, fatigue, and QOL. For ESRD patients undergoing haemodialysis, many previous studies have shown that exercise decreases fatigue and depression, and improves QOL. Accordingly, an intradialytic exercise program should be considered as a possible therapeutic approach for improving fatigue, depression, and QOL in ESRD populations and should be encouraged by and performed in haemodialysis centres. Although the benefits of related exercise programs are known, an effective intradialytic exercise program for routine therapy has not yet been developed. Few previous studies have implemented exercise programs to examine the effects of psychological factors and QOL on patients receiving haemodialysis in Taiwan.

Exercise self-efficacy is a crucial mediator of health behaviour. Self-efficacy is a key construct in social-cognitive theory, in which personal beliefs correspond to an individual's perceived ability to successfully perform specific tasks and activities. Pertaining to beliefs in a person's ability to manage prospective situations, self-efficacy beliefs focus on mediating change in individual behaviours. Thus, self-efficacy has a mediating effect on depression resulting from stressful events. Self-efficacy as a mediator complements family and healthcare provider support in diminishing the negative impact of depression in haemodialysis patients. Relevantly, resilient people tend to have apparent adaptive behaviours, particularly those related to somatic health. Resilience specifically refers to smooth and rapid recovery from setbacks that may occur in a person's life. As such, psychological resilience is considered a protective mechanism that operates in the presence of negative stressors. People who are maladaptive with low competence and low adversity score lower on these measures than resilient and competent groups do. Exercise self-efficacy, resilience, and exercise behaviour are interrelated. Self-efficacy may motivate people to perform their physical activity. However, the true effect of exercise programs fails to account for the mediating effects of exercise self-efficacy and resilience.

Purpose Statements The purpose of this study was to investigate the effect of an intradialytic aerobic and resistance cycling exercise program (IARCEP) on depression, fatigue, and QOL in ESRD patients receiving haemodialysis, and to further determine the effect of mediation through exercise self-efficacy and resilience in patients receiving the IARCEP.

METHODS Research Design and Participants This study adopted a randomised controlled trial design. ESRD participants were recruited from a haemodialysis centre in an 872-bed regional hospital in Northern Taiwan. Data were collected over a 14 months in 2013-2014. The exercise group received routine nursing care in addition to the IARCEP for 3 months. The control group received only routine care in the same study period. A randomisation procedure was performed outside of the study site by two nurse researchers. Permuted-block randomisation, for which every block comprised four patients, was adopted to balance the number of patients in the exercise and control groups. A randomisation list was drawn using random computer-generated sequences. Information regarding these sequences was separately placed in opaque, sealed envelopes to ensure that the participants were randomly allocated to the exercise or control group. Outcomes were repeatedly measured four times at baseline and the first, second, and third months.

Intradialytic aerobic and resistance cycling exercise program (IARCEP) An exercise program brochure for the IARCEP was made available to the exercise group participants to ensure that stationary cycling would be performed appropriately. A horizontal electromagnetic cycle ergometer (Medical Exercise Peddler 3000, Medi-Bike, Taiwan) was used for the participants' cycling performance. The exercise was performed during the first 2 hr of each haemodialysis session (30 min per session, 3 sessions per week for 3 months). All participants were assessed for cardiac and other medical contraindications to exercise by using PAR-Q. Participants were required to perform stationary cycling at an intensity of 11-13 out of 20, corresponding to the rate of perceived exertion on the Borg scale, whereby the intensity was 65%-85% of the participant's maximal capacity, representing the level at which cardiovascular health can be maintained. Exercise was paused when the participants had systolic blood pressure over 180 mmHg, diastolic blood pressure over 95 mmHg, heartbeat under 60 beats/min, or pulse oxyhaemoglobin saturation (SpO2) under 88%. The participants' cardiac rhythm was continuously monitored. Blood pressure and SpO2 was also measured every 5 min. The criteria for interrupting exercise included physical exhaustion, chest pain, dyspnoea, dizziness, and significant instabilities in heartbeat or blood pressure. Immediately following exercise, the participants were assisted with removing the stationary cycling gear to adopt a comfortable position for the immediate assessment of blood pressure, heart rate, and SpO2. Participants were included in the subsequent analysis if they performed the aforementioned exercise procedure at least 10 times per month.

Being tested
Medical Exercise Peddler 3000, Medi-Bike, Taiwan
Keywords
Nursing, ESRD, hemodialysis, intradialytic exercise, depression, fatigue, Quality Of Life, self-efficacy, resilience
Medical subject headings
Kidney Failure, Chronic, Depression, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medical Exercise Peddler 3000, Medi-Bike, TaiwanDevice

    A horizontal electromagnetic cycle ergometer (Medical Exercise Peddler 3000, Medi-Bike, Taiwan) was used for the exercise program. The cycling equipment includes the resistance of 6 Levels, from Level 1 the lightest to Level 6 the heaviest. Other indicators examined are RPM (rotary per minute), DICT (The distance for this exercise), TIME (The time of exercise). This is the simplest way to use this Motion Exercise Machine. Press the "ST / SP (Start/ Stop)" button to start an exercise program for 30 minutes.

Study groups in NCT02908594
Study groupRoleWhat they receive
exercise groupExperimentalUsing the Medical Exercise Peddler 3000, Medi-Bike, Taiwan as an exercise tool. Exercise group received routine care and 3- months exercise. The exercise was performed during the first 2 hr of each haemodialysis session (30 min per session, 3 sessions per week for 3 months).
Receives: Device: Medical Exercise Peddler 3000, Medi-Bike, Taiwan
control groupNo interventionThe control group received routine care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Generalized estimating equation model on the effects of depression, fatigue, and health-related quality of life

    Measured: Data were collected over a 14 months in 2013-2014.

Secondary outcomes (3)
  1. Differences-in-differences on the effects of the depression, fatigue, quality of life in exercise group

    Measured: Data were collected over a 14 months in 2013-2014.

  2. Generalized estimating equation on the mediated effects of self-efficacy and resilience with exercise on outcomes

    Measured: Data were collected over a 14 months in 2013-2014.

  3. The mediated effects on relationships between exercise and outcomes

    Measured: Data were collected over a 14 months in 2013-2014.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2016 (estimated)
  2. Study startJun 2013
  3. Primary completionAug 2014
  4. Study completionMay 2016

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02908594
Sponsor's protocol ID
CardinalTH
Status last verified
Sep 2016
First submitted
10 Sep 2016
Last updated
21 Sep 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Medical Exercise Peddler 3000, Medi-Bike, Taiwan in people with Kidney Failure, Chronic, run by Cardinal Tien Hospital.

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 7 inclusion and 5 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: finished, as of the sponsor's last update on 21 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Generalized estimating equation model on the effects of depression, fatigue, and health-related quality of life (time frame: Data were collected over a 14 months in 2013-2014.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 21 Sep 2016.

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