The Assessment of the Feasibility of a Home Based Exercise Programme in the Older Patient Following Major Surgery

NCT03064308 | Completed DMC

• 1 other identifier: 16014
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this study is to establish if it is possible for patients who have undergone major body surgery to complete a home based exercise training program and complete the assessments required to measure physical and cognitive function. If the investigators can establish that it is feasible to complete the training and test's then further research can follow using these methods to determine whether it is possible to improve the physical function of older patients undergoing major abdominal surgery in the period following surgery by using a simple exercise regimen that can be carried out at home. By targeting physical function in this way the investigators hope to determine if it is a method for improving frailty and well being. In turn it may also have a positive impact on health service provision.

Conditions

Impaired Cognition; Quality of Life; Surgery; Delirium; Colorectal Carcinoma; Bladder Carcinoma; Abdominal Hysterectomy (& Wertheim); Prostatic Neoplasms; Colon Carcinoma; Renal Carcinoma

Keywords

Frailty; Surgery; Physical function; Cognitive function; Quality of life; Exercise; Rehabilitation; Delirium; Morbidity; Mortality; Length of stay; Well-being; Elderly; Older surgical patient; Radical prostatectomy; Radical cystectomy; Radical cystoprostatectomy; Aortic Aneurysm Repair; Major Cavity Surgery; Abdominal Surgery; Recovery; Nephrectomy

Outcome Measures

Primary Outcomes (1)

• Feasibility of a home based exercise programme following surgery in the older patient.

  To determine the feasibility of a post-operative home based exercise program at 3 and 6 months, for older patients over 70 years of age, who have undergone major body cavity surgery. To assess if this approach is an acceptable and practically viable health intervention in this demographic group. The feasibility will be assessed through the use of interviews with the participants, review of the participants exercise diary and written participant feedback.

  3 and 6 months

Secondary Outcomes (9)

• Step Box Test

  3 and 6 months

• Muscle Architecture Ultrasound

  3 and 6 months

• Cognitive testing

  3 months

• Frailty

  3 and 6 months

• Subjective Outcome measure: Physical Activity.

  3 and 6 months

Other Outcomes (1)

• Intervention Compliance Questionnaire

  3 and 6 months

Study Arms (2)

Control

NO INTERVENTION

Participants will receive standard NHS care with no intervention.

Exercise

OTHER

Participants will receive standard NHS care and complete the exercise programme, the intervention.

Other: Exercise Programme

Interventions

Exercise Programme OTHER

Participants will complete the High-Intensity Functional Exercise (HIFE) programme. The programme improves lower-limb strength, balance and mobility and all the exercises can be performed by the individual at home and with minimal equipment.

Exercise

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients undergoing major body cavity surgery.
• Male and Female patients.
• Age greater than 70 years.
• Patients undergoing neo-adjuvant chemotherapy will be included.

You may not qualify if:

• Participation in a formal exercise regime
• A BMI \> 35 kg·m2
• Active cardiovascular disease: uncontrolled hypertension (BP \> 180/100), angina, heart failure (class III/IV), arrhythmia, right to left cardiac shunt, recent cardiac event
• Taking beta-adrenergic blocking agents.
• Cerebrovascular disease: untreated aneurysm (large vessel or intracranial).
• Respiratory disease including: pulmonary hypertension.
• Metabolic disease: hyper and hypo parathyroidism, untreated hyper and hypothyroidism, Cushing's disease.
• Musculoskeletal or neurological disorders
• Family history of early (\<55y) death from cardiovascular disease
• Severe rheumatoid arthritis limiting ability to perform any part of the assessment process.
• Unable to complete the consent process.

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

Division of Graduate Entry Medicine and Health, School of Medicine, University of Nottingham. Royal Derby Hospital,

Derby, Derbyshire, DE22 3DT, United Kingdom

Location

MeSH Terms

Conditions

Cognition Disorders; Delirium; Colorectal Neoplasms; Urinary Bladder Neoplasms; Prostatic Neoplasms; Colonic Neoplasms; Carcinoma, Renal Cell; Frailty; Motor Activity

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Genital Diseases; Prostatic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Neoplasms; Kidney Diseases; Pathologic Processes; Behavior

Study Officials

• John Williams, MBChB PhD

  Clinical Associate Professor and Consultant Anaesthetist

  STUDY CHAIR

• Bethan Phillips, BSc PhD

  Assistant Professor

  STUDY DIRECTOR

• Jon Lund, MD

  Clinical Associate Professor and Consultant Colorectal Surgeon

  STUDY DIRECTOR

• Laura Carrick, BSc MBChB

  Clinical Research Fellow, Specialist Registrar in Anaesthetics

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 25, 2016
• First Posted: February 27, 2017
• Study Start: June 26, 2017
• Primary Completion: July 26, 2018
• Study Completion: July 27, 2018
• Last Updated: April 17, 2019

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)