Long Term Physical Activity for Hemodialysis Patients

End Stage Renal Disease on Hemodialysis Clinical Trial

Official title:

Effects of One Year Perdialytic Physical Activity on Aerobic Capacities and Quality of Life in Hemodialysis Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02860312
• Other study ID #: AURAS
• Secondary ID: ID-RCB 2015-A003
• Status: Not yet recruiting
• Phase: N/A
• First received: July 14, 2016
• Last updated: August 4, 2016
• Start date: September 2016
• Est. completion date: May 2019

Study information

• Verified date: August 2016
• Source: AURA Sante
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial Summary

Patients on chronic hemodialysis present severe physical dysfunctioning associated with a significant reduction of their muscle mass. These two parameters are associated with increased morbidity and mortality along with deconditioning and poor quality of life. There are several studies- usually short term, single center uncontrolled and underpowered- that have shown a significant improvement of the physical, metabolic and dialytic parameters.

There are only few studies that have measured the impact of a long term intradialytic exercise intervention on a supervised manner. This is a multi-center controlled study examining the effects of intradialytic cycling on parameters of physical functioning, body composition, cardiovascular and nutritional status, immunological status and quality of life in a group of clinically stable hemodialysis patients

Description:

General Context Chronic Kidney Patients (CKD) live a sedentary life. Sedentarity and Sarcopenia worsen during the evolution of CKD with numerous cardiovascular diseases, infectious and other comorbidities. Inactivity may activate and amplify the inflammatory process, hypercoagulability, malnutrition, invoking a vicious circle of further inactivity and deconditioning.

These populations have a very low physical activity profile due to important tiredness, perturbed general condition and bad adaptation in effort. The patients with cardiovascular problems have additional limitations due to breathlessness associated with congestive cardiac failure and intermittent claudication due to peripheral arteriopathy. At the dialysis stages the tiredness is accentuated after the hemodialysis sessions. The days off dialysis are rarely used for practicing a physical activity.

The deconditioning along with the reduction of the physical activity are leading to a de-socializing progressing in the course of the chronic renal failure. In that way the patient feels more and more isolated with a serious eventual impact on the nutrition status and his quality of life.

Regular physical activity in this population of patients is exerting beneficial effects on insulin resistance, inflammation, dialysis efficiency, nutrition and arterial pressure. It may also reduce the intradialytic hypotensive episodes and improve quality of life, without side effects.

The objective of this study is to investigate an improvement of the physical functioning associated with a reprogramming of the autonomous nervous system, a reduction of the pro-inflammatory factors with a reduction of the insulin resistance (reduction of the metabolic syndrome), along with improvements on the immune system functioning for hemodialysis patients participating on a one year intradialytic physical activity program.

Principal objective :

The principal aim of the present study is to show the efficacy of intradialytic physical activity on functional capacity with the sit-to-stand test in 60 seconds (STS60) and the time to perform 5 complete sit-to-stand movements (STS5) along with a 6 minutes' walk test (6MWT).

Secondary objectives :

The secondary objectives are the amelioration of parameters associated with cardiovascular, sympathetic or autonomous nervous system, immune, nutritional, metabolic and inflammatory outcomes among with quality of life.

This is a multicenter, controlled randomized trial

Study description:

Inclusion of patients willing to participate in the study, and consequently their randomization in 2 groups.

The intervention group will benefit from a supervised physical activity during the dialysis session and the other group will carry on with his usual physical activities and have the same tests before and after the trial without undergoing a supervised intradialytic physical activity program

Primary judgment criteria :

The principal criteria will be the effect of an aerobic training program with a warming up phase, followed by 30 minutes of intradialytic cycling on 55% of the VO2max, 3 times a week.

The primary judgement criteria will be the improvement of the Sit-to-stand test in 60 seconds (STS60) and the time to complete 5 sit-to stand movements (STS5) as well as the 6 minutes' walk test (6MWT) from T0 (before the training program) to T12 (12 months after the start of the training period)

Secondary criteria:

• Quality of life parameters evaluated from the questionaries SF36 (The Short Form (36) Health Survey), Borg scale, EVA.

• Physical activity levels: IPAQ (international physical activity questionary).

• Body composition (Fat mass, lean mass, bone mineral density, estimation of the muscular mass) with DEXA (dual-energy x-ray absorptiometry).

• Cardiovascular parameters : Cardiac echography, doppler of the carotid arteries and the lower extremity arteries, 24h cardiac rhythm exploration

• Immune parameters: leucocyte subpopulation functioning

• Nutritional and metabolic parameters: weight, BMI, albumin, pre-albumin, pre- and post-dialytic serum urea and creatinine levels, nPCR (normalised Protein catabolic Rate).

• Inflammatory parameters :(Interleucin) IL1 bêta, IL6, IL8, IL-10, TNF alpha (Tumor necrosis factor alpha), CRP (C reactive protein)

• Dialysis parameters : Kt/v, anemia control : Hemoglobin (Hb), MCV (mean corpuscular volume), ferritin, erythropoetin dosage (EPO).

• Number, etiology and duration of hospitalisations

• Survival in 1 year

Number of participants : 100, ie 50 per group

Layout of the study :

Inclusion of the patient, evaluations at the start of the study protocol, at 6 months and at the end -12 months (M0, M6, M12).

Benefits and risks of this study :

Improvement of functional aerobic capacity, inflammatory status and quality of life. Improvements on the state of pain, autonomy, augmentation of the lean mass with conservation of the muscular mass for the lower extremities and reduction of the total fat mass are expected as well as improvement of the nutritional status, dialysis parameters, anemia control.

The risks are of cardiovascular origin: a possible decompensation of coronary artery disease, peripheral artery disease, taking into consideration that all patients benefit from echo doppler arterial control before the start of the study.

Regular Perdialytic Activity during Dialysis is practiced in AURA Auvergne (Association pour l'Utilisation du Rein Artificiel Santé) since 2 years; there has been no secondary vascular problem associated with the supervised physical activity. Nevertheless, rare tendon problems or articular and muscular pains could be possible on the course of the study

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 2019
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

• Consenting active hemodialysis patients since at least 6 months aged between 20 and 90 y.o.

Exclusion Criteria:

• Unstable angina,

• severe left ventricular dysfunction,

• Ejection fraction < 30%,

• severe peripheral arterial disease,

• lower extremity amputation,

• impossibility of physical effort: pain, uncontrolled bone/muscular disease,

• participation on another study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Disease on Hemodialysis
• Kidney Failure, Chronic

Intervention

Behavioral:
• Intradialytic exercise on stationary bicycles
Patients are exercising for 30-60 min during dialysis on an Rated Perceived Exertion (RPE) Scale between 12 and 14
• Non-exercising group
Patients are having their usual physical activity

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AURA Sante

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of the distance covered after walking for 6 minutes (6 minutes walk test)	The principal aim of the present study is to show the efficacy of intradialytic physical activity on the improvement of the physical capacity of the patients assessed with the 6 minutes walk test ((6MWT)	12 months	No
Secondary	Quality of life parameters 1	Quality of life parameters evaluated from the questionnaire SF36 QD	12 months	No
Secondary	Quality of life parameters 2	Quality of life parameters evaluated from the questionnaire Borg scale	12 months	No
Secondary	Quality of life parameters 3	Quality of life parameters evaluated from the EVA scale	12 months	No
Secondary	Physical activity levels	Physical activity levels from the questionnary IPAQ (international physical activity questionnairy)	12 months	No
Secondary	Body composition	Body composition (Fat mass, lean mass, bone mineral density, estimation of the muscular mass) with DEXA ccanning and bioimpendance	12 months	No
Secondary	Cardiovascular parameters	Cardiovascular parameters : Cardiac echography, echodoppler of the carotid arteries and the lower extremity arteries, 24h cardiac rythm exploration	12 months	No
Secondary	Immune parametres	Immune parametres: leucocyte subpopulation fonctioning	12 months	No
Secondary	Nutritional and metabolic parameters 1	BMI	12 months	No
Secondary	Nutritional and metabolic parameters 2	serum albumin levels	12 months	No
Secondary	Nutritional and metabolic parameters 3	serum prealbumin levels	12 months	No
Secondary	Nutritional and metabolic parameters 4	pre and post dialytic serum urea levels	12 months	No
Secondary	Nutritional and metabolic parameters 5	pre and post dialytic serum creatinine levels	12 months	No
Secondary	Nutritional and metabolic parameters 6	nPCR (normalised Protein Catabolic Rate)	12 months	No
Secondary	inflammatory parameters 1	IL1 bêta	12 months	No
Secondary	inflammatory parameters 2	IL6	12 months	No
Secondary	inflammatory parameters 3	IL8	12 months	No
Secondary	inflammatory parameters 4	IL-10	12 months	No
Secondary	inflammatory parameters 5	TNF alpha	12 months	No
Secondary	inflammatory parameters 6	CRP	12 months	No
Secondary	Dialysis parameters	Kt/V	12 months	No
Secondary	Anemia control 1	Hemoglobin (Hb)	12 months	No
Secondary	Anemia control 2	MCV (mean corpuscular volume)	12 months	No
Secondary	Anemia control 3	Ferritine	12 months	No
Secondary	Anemia control 4	Erythropoetine dosage (EPO).	12 months	No
Secondary	Number of hospitalisations	Number of hospitalisations	12 months	No
Secondary	Duration of hospitalisations	Duration of hospitalisations	12 months	No
Secondary	Survival	Survival in one year	12 months	No
Secondary	Improvement of Sit to Stand test in 60 seconds (STS60)	The physical capacity of the patients assessed with the number of cycles performed during a sit-to-stand test in 60 seconds (STS60).	12 months	No
Secondary	Improvement of the time needed to perform 5 Sit to Stand cycles (STS5)	Time needed to perform 5 Sit to Stand cycles (STS5)	12 months	No