Investigating the Anabolic Response to Resistance Exercise After Critical Illness (ARTIST-2)

NCT05261984 | Completed

• 1 other identifier: K 2022-1113
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

ICU survivors often suffer from long-term functional disability. An attenuated response to physical exercise in skeletal muscle after critical illness may contribute to persisting weakness. The aim of this study is to investigate the effects of resistance exercise on muscle protein synthesis in former ICU patients. The investigators hypothesize that study subjects recovering from critical illness have an impaired anabolic response to resistance exercise after ICU stay as compared to non-critically ill controls.

Conditions

Critical Illness; Muscle Loss

Keywords

Resistance exercise; Muscle protein; Anabolic resistance

Outcome Measures

Primary Outcomes (1)

• Muscle protein fractional synthetic rate

  The difference between the experimental and active comparator group in muscle protein fractional synthetic rate.

  150 minutes post-exercise.

Secondary Outcomes (2)

• Gene expression

  150 minutes post-exercise.

• Signaling pathways

  150 minutes post-exercise.

Study Arms (2)

Former ICU patients

EXPERIMENTAL

Research subjects with a prior history of ICU treatment within six months.

Procedure: Resistance exercise; Dietary Supplement: Oral protein supplementation

Age- and sex-matched control group

ACTIVE COMPARATOR

Research subjects without a prior history of ICU treatment within the last 30 years, age- and sex-matched in a 1:2 ratio to the experimental arm.

Procedure: Resistance exercise; Dietary Supplement: Oral protein supplementation

Interventions

Resistance exercise PROCEDURE

Knee extensions in flywheel inertia machine in four sets of 10 repetitions.

Age- and sex-matched control group; Former ICU patients

Oral protein supplementation DIETARY_SUPPLEMENT

24 grams of hydrolyzed whey protein.

Age- and sex-matched control group; Former ICU patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (≥18 years) previously admitted to an ICU at Karolinska University Hospital for ≥3 days and discharged alive from hospital
• Adult (≥18 years) without a history of ICU admission (control group)

You may not qualify if:

• Not able to provide informed consent
• \>6 months since ICU discharge\*
• Warfarin or dual antiplatelet therapy
• Clinically significant inherited or acquired disorder of hemostasis
• Lower-limb amputee
• Lower-limb atherosclerotic disease with critical ischemia.
• Recent fracture in lower limbs or significant osteoarthritis limiting movement in knee or hip joint
• Metastatic cancer or active hematological malignancy
• Inherited disorder of amino acid metabolism.
• Chronic muscle, neuromuscular or neurologic disease with prior documentation of clinically significant lower-limb involvement
• Pregnancy
• Single organ failure not requiring invasive mechanical ventilation during ICU stay\*
• Intubated only for airway protection with no other organ failure(s) during ICU stay\*
• Planned postoperative care in ICU after elective cardiothoracic surgery\*

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (1)

Karolinska University Hospital

Huddinge, Stockholm County, 14186, Sweden

Location

Related Publications (9)

• Batt J, Herridge MS, Dos Santos CC. From skeletal muscle weakness to functional outcomes following critical illness: a translational biology perspective. Thorax. 2019 Nov;74(11):1091-1098. doi: 10.1136/thoraxjnl-2016-208312. Epub 2019 Aug 20.

  PMID: 31431489 BACKGROUND

• Herridge MS, Tansey CM, Matte A, Tomlinson G, Diaz-Granados N, Cooper A, Guest CB, Mazer CD, Mehta S, Stewart TE, Kudlow P, Cook D, Slutsky AS, Cheung AM; Canadian Critical Care Trials Group. Functional disability 5 years after acute respiratory distress syndrome. N Engl J Med. 2011 Apr 7;364(14):1293-304. doi: 10.1056/NEJMoa1011802.

  PMID: 21470008 BACKGROUND

• Plank LD, Connolly AB, Hill GL. Sequential changes in the metabolic response in severely septic patients during the first 23 days after the onset of peritonitis. Ann Surg. 1998 Aug;228(2):146-58. doi: 10.1097/00000658-199808000-00002.

  PMID: 9712558 BACKGROUND

• Puthucheary ZA, Rawal J, McPhail M, Connolly B, Ratnayake G, Chan P, Hopkinson NS, Phadke R, Dew T, Sidhu PS, Velloso C, Seymour J, Agley CC, Selby A, Limb M, Edwards LM, Smith K, Rowlerson A, Rennie MJ, Moxham J, Harridge SD, Hart N, Montgomery HE. Acute skeletal muscle wasting in critical illness. JAMA. 2013 Oct 16;310(15):1591-600. doi: 10.1001/jama.2013.278481.

  PMID: 24108501 BACKGROUND

• Wolfe RR. Skeletal muscle protein metabolism and resistance exercise. J Nutr. 2006 Feb;136(2):525S-528S. doi: 10.1093/jn/136.2.525S.

  PMID: 16424140 BACKGROUND

• Doiron KA, Hoffmann TC, Beller EM. Early intervention (mobilization or active exercise) for critically ill adults in the intensive care unit. Cochrane Database Syst Rev. 2018 Mar 27;3(3):CD010754. doi: 10.1002/14651858.CD010754.pub2.

  PMID: 29582429 BACKGROUND

• Connolly B, Salisbury L, O'Neill B, Geneen L, Douiri A, Grocott MP, Hart N, Walsh TS, Blackwood B; ERACIP Group. Exercise rehabilitation following intensive care unit discharge for recovery from critical illness. Cochrane Database Syst Rev. 2015 Jun 22;2015(6):CD008632. doi: 10.1002/14651858.CD008632.pub2.

  PMID: 26098746 BACKGROUND

• Fossat G, Baudin F, Courtes L, Bobet S, Dupont A, Bretagnol A, Benzekri-Lefevre D, Kamel T, Muller G, Bercault N, Barbier F, Runge I, Nay MA, Skarzynski M, Mathonnet A, Boulain T. Effect of In-Bed Leg Cycling and Electrical Stimulation of the Quadriceps on Global Muscle Strength in Critically Ill Adults: A Randomized Clinical Trial. JAMA. 2018 Jul 24;320(4):368-378. doi: 10.1001/jama.2018.9592.

  PMID: 30043066 BACKGROUND

• Hickmann CE, Castanares-Zapatero D, Deldicque L, Van den Bergh P, Caty G, Robert A, Roeseler J, Francaux M, Laterre PF. Impact of Very Early Physical Therapy During Septic Shock on Skeletal Muscle: A Randomized Controlled Trial. Crit Care Med. 2018 Sep;46(9):1436-1443. doi: 10.1097/CCM.0000000000003263.

  PMID: 29957714 BACKGROUND

MeSH Terms

Conditions

Critical Illness; Muscular Atrophy

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Martin Sundström Rehal, MD PhD

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

• Olav Rooyackers, PhD

  Karolinska University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 20, 2022
• First Posted: March 2, 2022
• Study Start: March 8, 2022
• Primary Completion: January 18, 2024
• Study Completion: January 18, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)