Strength Training in Hospitalized Patients Using the Ghostly App: a Feasibility Study

NCT ID: NCT05258500

Last Updated: 2024-10-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2026-09-30

Brief Summary

The goal of this feasibility study is to evaluate the use of the Ghostly app in rehabilitation of stroke patients, elderly and patients recovering from COVID-19 or ICU patients. In three randomized controlled trials, the effect of a strength training program incorporated in the Ghostly app will be assessed for 1) stroke patients suffering from weakness of the lower limb, 2) frail elderly with gait difficulties and 3) patients recovering from COVID-19 or ICU patients who suffer from muscle weakness. Additionally, the effect of BFR on strength gain in all these three populations will be tested.

Detailed Description

STUDY DESIGN: The focus of this study can be divided into two research questions. On the one hand, the effectiveness of the Ghostly app (as an additional training to conventional therapy) in relation to strength gain will be investigated. And on the other hand, the effect of BFR during isometric strength training compared to standard isometric strength training will be tested. For this study, a gaming app (Ghostly) was developed in which the main character is controlled through muscle contractions measured using electromyography (EMG). EMG-electrodes connected to the Ghostly app will be placed on the targeted muscles and register muscle contractions. The purpose of the app is to train the muscles in a stimulating and challenging environment by completing levels. These levels are adjusted to adhere to strength training guidelines based on literature. In total three single-blinded randomized controlled trials (RCT) will be organized in which one RCT investigates acute and subacute stroke patients, one RCT investigates hospitalized elderly and one RCT investigates patients recovering from COVID-19 and ICU patients. Each population will be randomized into three groups using sealed envelopes containing ten notes which will be marked with "Ghostly", followed by "A"(conventional therapy) or "B" (blood flow restriction), and five notes marked "leaflet". Every group will receive dose-matched conventional therapy, but the second experimental group will receive an adjusted version of their conventional therapy which includes isometric strength training using blood flow restriction. Each group will also receive instructions for an additional strength training program which participants will have to complete unsupervised. The first and second group will receive the strength training program incorporated in the Ghostly app. The control group on the other hand will be given a leaflet which includes instructions on performing exercises without the use of the Ghostly app. These exercises will be matched in terms of repetitions, sets and inter-set rest to match the intensity of the Ghostly app.

ANALYSIS: After the data for the entire sample is collected, the analysis will be performed using SPSS 27 (IBM, New York). A significance level of 0.05 will be used throughout the entire analysis.

Descriptive statistics of the baseline characteristics of all participants will be performed. A normal distribution of the data will be assessed using the Levene's test. Two-way repeated measures analysis of variance (ANOVA) will be used to assess the differences in dependent variables with respect to within-group variables and between-group variables. These differences will be expressed as mean differences. Additionally, a Tukey post hoc test will be done to compare mean differences for true significance.

For the analysis of the USE questionnaire, percentage distribution of every item and mean scores for every subscale will be calculated using Microsoft Excel (Microsoft, Washington, DC).

Conditions

Stroke; COVID-19; Frailty; Muscle Weakness; Sarcopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ghostly

The first arm consists of a strength training program incorporated in the Ghostly game that will be given to the patient to be completed without supervision of the therapist as an added exercise program to their conventional therapy.

Group Type: EXPERIMENTAL

Ghostly app

Intervention Type: OTHER

For the Ghostly app, we include three different trainings (standard, cluster set 1, cluster set 2). The standard training consists of three sets in which twelve muscle contractions are performed with 120 seconds of rest between each set. Each set of twelve contractions will be considered as one level in the game that needs to be ended before taking rest of 120s. Subsequently, the 'Cluster set 1' training is based on the training modalities of cluster set training since evidence shows that similar results can be obtained using cluster set training compared to standard training. The Cluster sets 1 and 2 also consist of 3 sets of twelve repetitions, but with ten seconds of rest between each contraction or 30 seconds of rest after three consecutive contractions respectively. The intensity at which will be trained is 75% of maximum voluntary contraction.

Blood flow restriction and Ghoslty

The second intervention arm incorporates blood flow restriction into the conventional therapy using the Smart Cuffs PRO system (Smart Tools, USA). Additionally, these participants will receive additional exercises added to their conventional therapy using the Ghostly game

Group Type: EXPERIMENTAL

Ghostly app

Intervention Type: OTHER

For the Ghostly app, we include three different trainings (standard, cluster set 1, cluster set 2). The standard training consists of three sets in which twelve muscle contractions are performed with 120 seconds of rest between each set. Each set of twelve contractions will be considered as one level in the game that needs to be ended before taking rest of 120s. Subsequently, the 'Cluster set 1' training is based on the training modalities of cluster set training since evidence shows that similar results can be obtained using cluster set training compared to standard training. The Cluster sets 1 and 2 also consist of 3 sets of twelve repetitions, but with ten seconds of rest between each contraction or 30 seconds of rest after three consecutive contractions respectively. The intensity at which will be trained is 75% of maximum voluntary contraction.

Blood flow restriction

Intervention Type: OTHER

Patients will complete four sets of 15 repetitions, with each contraction lasting three seconds. Similar to the first experimental group and control group, the training intensity will be set at 100%MVC with two minutes of rest between sets. The cuff pressure will be set at 50% of arterial occlusion pressure.

Control

The control group will not be given the Ghostly game as additional exercises to complete after their conventional therapy, but will receive instructions for a strength training program targeting the same muscles as both intervention groups.

Group Type: ACTIVE_COMPARATOR

Leaflet

Intervention Type: OTHER

This training program will be matched with the Ghostly game in terms of repetitions, sets and inter-set rest and will be given to the patient to complete without supervision of the therapist.

Interventions

Ghostly app

For the Ghostly app, we include three different trainings (standard, cluster set 1, cluster set 2). The standard training consists of three sets in which twelve muscle contractions are performed with 120 seconds of rest between each set. Each set of twelve contractions will be considered as one level in the game that needs to be ended before taking rest of 120s. Subsequently, the 'Cluster set 1' training is based on the training modalities of cluster set training since evidence shows that similar results can be obtained using cluster set training compared to standard training. The Cluster sets 1 and 2 also consist of 3 sets of twelve repetitions, but with ten seconds of rest between each contraction or 30 seconds of rest after three consecutive contractions respectively. The intensity at which will be trained is 75% of maximum voluntary contraction.

Intervention Type: OTHER

Blood flow restriction

Patients will complete four sets of 15 repetitions, with each contraction lasting three seconds. Similar to the first experimental group and control group, the training intensity will be set at 100%MVC with two minutes of rest between sets. The cuff pressure will be set at 50% of arterial occlusion pressure.

Intervention Type: OTHER

Leaflet

This training program will be matched with the Ghostly game in terms of repetitions, sets and inter-set rest and will be given to the patient to complete without supervision of the therapist.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Hospitalized
• Subacute/acute stroke
• Score of 19 or lower on the knee and hip movement test of the Motricity Index

• Hospitalized
• 65+ yrs
• 14 or less repetitions on the 30 seconds sit-to-stand test

• Hospitalized
• Recovering from COVID-19 or ICU patient
• score of 2 or less for manual muscle testing of the quadriceps muscle in both legs

Exclusion Criteria

• Unable to understand the instructions
• Other disabilities (muscular, orthopedic, …)
• Pregnancy
• Metal implants
• Implanted electrical devices

• Unable to understand the instructions
• Other disabilities (muscular, orthopedic, …)
• Metal implants
• Implanted electrical devices

• Unable to understand the instructions
• Other disabilities (muscular, orthopedic, …)
• Pregnancy
• Metal implants
• Implanted electrical devices

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: collaborator

Revalidatieziekenhuis InkendaaI

NETWORK

Sponsor Role: collaborator

Vrije Universiteit Brussel

OTHER

Sponsor Role: lead

Responsible Party

Ruben Debeuf

The Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eva Swinnen, Prof. Ph.D

Role: PRINCIPAL_INVESTIGATOR

Vrije Universiteit Brussel

Locations

Vrije Universiteit Brussel

Jette, Brussels Capital, Belgium

Site Status: RECRUITING

University Hospital Brussels

Brussels, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Ruben Debeuf

Role: CONTACT

ruben.debeuf@vub.be

0032478821658

Eva Swinnen, Prof. Ph.D

Role: CONTACT

eva.swinnen@vub.be

003224774527

Other Identifiers

Ghostly

Identifier Type: -

Identifier Source: org_study_id