Home-based Prehabilitation for Elderly Patients

NCT03964363 | Completed

• 1 other identifier: PV5951
• Study Type: interventional
• Target: 512
• Locations: 1 country
• Sites: 3

Brief Summary

As a consequence of the increasing life expectancy hospitals are seeing a growing number of elderly patients undergoing elective surgery. These patients are likely to suffer from one or more chronic illnesses, malnutrition, reduced physical strength and mobility and sensory impairment. Age related loss of resilience in combination with these conditions often results in frailty. Frailty syndrome describes a reduction in weight, mobility and strength, as well as declining cognitive capacities and reduced performance in daily life activities. This decline in constitution is accompanied by an increased risk of complications and mortality in the period after surgery. Frail patients are generally admitted to hospital for a longer period and are readmitted more often. A multitude of studies has demonstrated that these risks can be significantly reduced by offering frail patients a prevention program prior to their surgery. These prevention programs are often referred to as prehabilitation and combine strength and cardiovascular training with breathing exercises. Despite the obvious benefits, prehabilitation programs are not yet commonly applied outside of research settings as they carry considerable costs and required additional skilled personnel. In response to the unmet need for a widely applicable, cost and personnel efficient prehabilitation program a home-based prehabilitation program has been designed. This prehabilitation allows patients to safely perform an individualised set of exercises without relying on a personal trainer or a training group. Efficiency and feasibility will be evaluated in this study.

Conditions

Frail Elderly Syndrome

Keywords

Frailty; preoperative period; surgery; breathing exercise; postoperative complications; resistance training; endurance training; anaesthesia; activities of daily living; patient reported outcome; prehabilitation; perioperative care; elderly; prevention

Outcome Measures

Primary Outcomes (1)

• Quality of recovery: QoR-15

  The quality of recovery after surgery and anaesthesia is measured using the QoR-15 questionnaire. The resulting score indicates self-reported patent well-being and perceived support with higher scores (0-100) indicating a better quality of recovery. (8)

  7 days postoperative

Secondary Outcomes (8)

• Quality of recovery: QoR-15

  3 months postoperative

• Health related quality of life: Questionnaire Short Form-12 (SF-12)

  preoperative, 3 months postoperative

• Activities of daily living

  preoperative, 7 days and 3 months postoperative

• Cognitive performance

  preoperative, 7 days and 3 months postoperative

• Mobility

  preoperative, 3 months postoperative

Study Arms (4)

Prehabilitation

EXPERIMENTAL

Participants are scheduled for elective surgery and follow the home-based prehabilitation for 11-17 days

Behavioral: Unsupervised home-based physical prehabilitation

Prehabilitation + TAVI

EXPERIMENTAL

Study participants who will undergo a TAVI form a subgroup with a modified enrolment procedure and longer duration of the intervention. The prehabilitation period is extended to 30 days.

Behavioral: Unsupervised home-based physical prehabilitation

Control

NO INTERVENTION

Participants are initially evaluated for frailty prior to scheduled surgery but subsequently receive regular care without a prehabilitation program. All pre- and postsurgical evaluations will be identical to the prehabilitation group.

Control+TAVI

NO INTERVENTION

The subgroup of participants who undergo a TAVI will be compared to a group of patients who will have had the same procedure. Hence the control group will also receive a screening via phone but then receive regular care. Follow-up after surgery will be identical in all groups.

Interventions

Unsupervised home-based physical prehabilitation BEHAVIORAL

Subsequent to screening and initial testing for frailty syndrome, participants receive an information booklet containing a selection of exercises, which allows independent prehabilitation at home.

Prehabilitation; Prehabilitation + TAVI

Eligibility Criteria

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

You may qualify if:

• pre-frail or frail according to (Longitudinal Urban Cohort Ageing Study) LUCAS-functional index
• scheduled for elective surgery
• planned ward admission for at least 24h after surgery

You may not qualify if:

• Refusal of participation
• Presentation less than 2 weeks prior to scheduled procedure
• Pre-existing pronounced immobility (wheelchair bound, paresis of both arms or both legs)
• Minor surgical interventions such as small excisions of superficial tissues, small interventions for haemorrhoids, curettage, gastroscopy

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (3)

Rotkreuzklinikium München

München, Bavaria, 80634, Germany

Location

University Medical Center Eppendorf

Hamburg, Hamburg, 20247, Germany

Location

Agaplesion Diakonieklinikum Hamburg

Hamburg, Hamburg, 20259, Germany

Location

Related Publications (8)

• Kim SW, Han HS, Jung HW, Kim KI, Hwang DW, Kang SB, Kim CH. Multidimensional frailty score for the prediction of postoperative mortality risk. JAMA Surg. 2014 Jul;149(7):633-40. doi: 10.1001/jamasurg.2014.241.

  PMID: 24804971 BACKGROUND

• Makary MA, Segev DL, Pronovost PJ, Syin D, Bandeen-Roche K, Patel P, Takenaga R, Devgan L, Holzmueller CG, Tian J, Fried LP. Frailty as a predictor of surgical outcomes in older patients. J Am Coll Surg. 2010 Jun;210(6):901-8. doi: 10.1016/j.jamcollsurg.2010.01.028. Epub 2010 Apr 28.

  PMID: 20510798 BACKGROUND

• Jadczak AD, Makwana N, Luscombe-Marsh N, Visvanathan R, Schultz TJ. Effectiveness of exercise interventions on physical function in community-dwelling frail older people: an umbrella review of systematic reviews. JBI Database System Rev Implement Rep. 2018 Mar;16(3):752-775. doi: 10.11124/JBISRIR-2017-003551.

  PMID: 29521871 BACKGROUND

• Boden I, Skinner EH, Browning L, Reeve J, Anderson L, Hill C, Robertson IK, Story D, Denehy L. Preoperative physiotherapy for the prevention of respiratory complications after upper abdominal surgery: pragmatic, double blinded, multicentre randomised controlled trial. BMJ. 2018 Jan 24;360:j5916. doi: 10.1136/bmj.j5916.

  PMID: 29367198 BACKGROUND

• Beggs T, Sepehri A, Szwajcer A, Tangri N, Arora RC. Frailty and perioperative outcomes: a narrative review. Can J Anaesth. 2015 Feb;62(2):143-57. doi: 10.1007/s12630-014-0273-z. Epub 2014 Nov 25.

  PMID: 25420470 BACKGROUND

• Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051.

  PMID: 16129869 BACKGROUND

• Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.

  PMID: 23411725 BACKGROUND

• Jammer I, Wickboldt N, Sander M, Smith A, Schultz MJ, Pelosi P, Leva B, Rhodes A, Hoeft A, Walder B, Chew MS, Pearse RM; European Society of Anaesthesiology (ESA) and the European Society of Intensive Care Medicine (ESICM); European Society of Anaesthesiology; European Society of Intensive Care Medicine. Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures. Eur J Anaesthesiol. 2015 Feb;32(2):88-105. doi: 10.1097/EJA.0000000000000118.

  PMID: 25058504 BACKGROUND

MeSH Terms

Conditions

Frailty; Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Cynthia Olotu, MD

  Department of Anaesthesiology, University Medical Center Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This trail is designed as a prospective, multicentre, randomized controlled study with two parallel groups with a total of four arms. Patients with a scheduled elective surgery will be randomly assigned into treatment and control group after having been screened for frailty. A subgroup will be formed by patients who will receive a transcatheter aortic valve implantation (TAVI). The preventative effect of a behaviour modification will subsequently be compared.

Study Record Dates

• First Submitted: April 28, 2019
• First Posted: May 28, 2019
• Study Start: May 29, 2019
• Primary Completion: September 15, 2024
• Study Completion: October 12, 2024
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)