GERAS Frailty Rehabilitation at Home During COVID-19

NCT04500366 | Completed

• 1 other identifier: 11408
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The coronavirus disease 2019 (COVID-19) pandemic is keeping people apart, which can take a toll on physical and mental health. Many healthcare professionals are concerned vulnerable seniors may become deconditioned, which substantially increases risk of health complications and need for hospitalization. To address the immediate impact of COVID-19 policies (i.e., physical distancing, reduced access to care), the GERAS Frailty Rehabilitation model will be adapted to be delivered remotely in the homes of vulnerable seniors. The investigators' aim is to understand how to best build resilience among vulnerable seniors in the community through at-home rehabilitation services (socialization, exercise, nutrition, and medication support).

Conditions

Frailty

Keywords

Rehabilitation; Frailty; COVID-19; Exercise; Protein; Medication

Outcome Measures

Primary Outcomes (2)

• Change in Physical Function

  Assessed by the 5x Sit-to-Stand (time to complete). Faster times to complete indicate better performance.

  Baseline and 12 Weeks Post-Intervention

• Change in Mental Health

  Assessed by the Depression Anxiety Stress Scale (DASS-21). Higher scores indicate greater risk of depression, anxiety and stress \[depression, anxiety, stress subscores range 0-21\].

  Baseline and 12 Weeks Post-Intervention

Secondary Outcomes (12)

• Change in Sarcopenia

  Baseline and 12 Weeks Post-Intervention

• Change in Frailty

  Baseline and 12 Weeks Post-Intervention

• Change in Self-Efficacy

  Baseline and 12 Weeks Post-Intervention

• Self-Reported Change in Function, Health and Well-Being

  Baseline and 12 Weeks Post-Intervention

• Clinician-Reported Change in Function, Health and Well-Being

  Baseline and 12 Weeks Post-Intervention

Other Outcomes (4)

• Feasibility Outcome #1 - Reach of intervention

  12 Weeks Post-Intervention

• Feasibility Outcome #2 - Adoption of the Intervention

  12 Weeks Post-Intervention

• Feasibility Outcome #3 - Implementation of the Intervention

  12 Weeks Post-Intervention

Study Arms (2)

Socialization

ACTIVE COMPARATOR

Participants randomized to the socialization arm will receive once-weekly phone calls from medical student volunteers for a total of 12-weeks (n=35). This program pairs health professional student volunteers with older adults in the community to provide social comfort while heightened physical distancing measures are in place during the current COVID-19 pandemic. Attendance and duration of the phone calls will be logged.

Behavioral: Socialization

Multi-Modal Frailty Rehabilitation

EXPERIMENTAL

Multi-modal frailty rehabilitation will involve virtual care including 1x/week socialization, 2x/week exercise (small group physiotherapy live-streamed sessions), nutrition (virtual consult), and medication support (virtual pharmacist consult) all through a videoconferencing system.

Behavioral: Socialization; Behavioral: Virtual Group Exercise; Combination Product: Nutrition Consult and Protein Supplementation; Behavioral: Medication Review

Interventions

Socialization BEHAVIORAL

Social interaction is associated with better mental and physical health, and evidence suggests that group versus individual engagement may offer unique cognitive benefits for older adults as well as peer reinforcement and encouragement.

Multi-Modal Frailty Rehabilitation; Socialization

Virtual Group Exercise BEHAVIORAL

Participants will receive twice-weekly (one hour per class) virtual exercise via small-group physiotherapy sessions for a total of 12 weeks. All exercise sessions will occur virtually via a videoconferencing system. The classes will focus on functional movements specifically designed for seniors with frailty and mobility challenges, and will include modifications for gait aids such as canes or walkers. Class sizes will be small to allow for tailoring of exercises based on challenging, safe, progressive, evidence-based exercises. In accordance with recent guidelines to achieve 3 hours/week for fall prevention practice in older adults, participants will also be provided with tailored supplemental home exercises developed by the study physiotherapist to gain an additional 1 hour of physical activity.

Multi-Modal Frailty Rehabilitation

Nutrition Consult and Protein Supplementation COMBINATION_PRODUCT

Nutrition Consult: Participants will be scheduled for a one-on-one virtual nutrition consult. During the consultation, study staff will assess the nutritional status of the participant and will provide them with counselling and coaching to improve their nutrition. Protein Supplementation: Oral nutrition supplements commercially available from Nestle will be provided unless contraindicated. The oral nutrition supplement contains 360 calories and 14 grams of protein per serving. Participants are advised to take this with a meal or within 3 hours of exercise on activity days.

Multi-Modal Frailty Rehabilitation

Medication Review BEHAVIORAL

A study pharmacist will review the participant's medication list and will utilize Beers and/or START/STOPP criteria to provide recommendations to optimize/update their medications to the participant's healthcare provider. Study geriatricians will be listed as contacts on the primary care provider recommendations and available for consultation.

Multi-Modal Frailty Rehabilitation

Eligibility Criteria

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

You may qualify if:

• Community-dwelling adults aged ≥ 65 years of age;
• Score between 4-6 (inclusive) on the clinical frailty scale;
• Able to ambulate independently with or without a walking aid; OR with caregiver supervision at home;
• Obtain clearance for exercise: For hospital referrals - average resting heart rate between 50-100 bpm and average blood pressure less than or equal to 160/90mmHg (as per Canadian Society for Exercise Physiology guidelines for exercise clearance); OR Self- referrals: Obtain exercise clearance from their family physician prior to the first intervention session.

You may not qualify if:

• Unable to speak or understand English and has no caregiver for translation;
• Significant cognitive impairment where they may have difficulty following two-step commands;
• Receiving palliative/end of life care;
• Unstable angina or unstable heart failure;
• Travel plans that would result in missing greater than 20% of the trial's 12-week duration;
• Currently attending a group exercise program.

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University - Hamilton Health Sciences (St. Peter's Site)

Hamilton, Ontario, L8M1W9, Canada

Location

Related Publications (1)

• Okpara C, Ioannidis G, Thabane L, Adachi JD, Rabinovich A, Hewston P, Lee J, McArthur C, Kennedy C, Woo T, Boulos P, Bobba R, Wang M, Thrall S, Mangin D, Marr S, Armstrong D, Patterson C, Bray S, de Wit K, Maharaj S, Misiaszek B, Sookhoo JB, Thompson K, Papaioannou A. The Geras virtual frailty rehabilitation program to build resilience in older adults with frailty during COVID-19: a randomized feasibility trial. Pilot Feasibility Stud. 2023 Jul 17;9(1):124. doi: 10.1186/s40814-023-01346-7.

  PMID: 37461117 DERIVED

MeSH Terms

Conditions

Frailty; COVID-19; Motor Activity

Interventions

Medication Review

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Behavior

Intervention Hierarchy (Ancestors)

Medication Systems; Organization and Administration; Health Services Administration; Patient Care Management

Study Officials

• Alexandra Papaioannou, MD, MSc

  Scientific Director, GERAS Centre for Aging Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Outcome assessors, the study biostatistician, the investigative team, and the steering committee will be blinded to intervention assignments. Research assistants, study intervention personnel (pharmacist, instructors) and participants will not be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, GERAS Centre for Aging Research

Model Details: Participants will be randomized into two arms (35/arm based on sample size calculation) for 12-weeks of socialization only or multi-modal frailty rehabilitation. The socialization only arm will receive 1x/week phone calls from medical student volunteers. Multi-modal frailty rehabilitation will involve virtual care including 1x/week socialization, 2x/week exercise (small group physiotherapy live-streamed sessions), nutrition (virtual consult), and medication support (virtual pharmacist consult) all via a videoconferencing service.

Study Record Dates

• First Submitted: July 31, 2020
• First Posted: August 5, 2020
• Study Start: August 26, 2020
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: March 7, 2022

Record last verified: 2022-03

Locations

CA (1)