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

NCT05258500 | Completed

• 1 other identifier: Ghostly
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Change in muscle strength from baseline to 2 weeks of intervention

  Muscle strength of the quadriceps muscle will be measured using the MicroFET dynamometer

  From baseline to 2 weeks of intervention

• Change in muscle strength from baseline to 6 weeks of intervention or when the participants is discharged from the hospital

  Muscle strength of the quadriceps muscle will be measured using the MicroFET

  From baseline to 6 weeks of intervention or when the participant is discharged from the hospital

Secondary Outcomes (19)

• Change in cross sectional area of the muscle from baseline to 2 weeks of intervention

  From baseline to 2 weeks of intervention

• Change in cross sectional area of the muscle from baseline to 6 weeks of intervention or when the participants is discharged from the hospital

  From baseline to 6 weeks of intervention or when the participant is discharged from the hospital

• Change in pennation angle from baseline to 2 weeks of intervention

  From baseline to 2 weeks of intervention

• Change in pennation angle from baseline to 6 weeks of intervention or when the participants is discharged from the hospital

  From baseline to 6 weeks of intervention or when the participant is discharged from the hospital

• Change in echo intensity from baseline to 2 weeks of intervention

  From baseline to 2 weeks of intervention

Other Outcomes (1)

• Feasibility of the research protocol

  Up to 6 weeks of intervention

Study Arms (3)

Ghostly

EXPERIMENTAL

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.

Other: Ghostly app

Blood flow restriction and Ghoslty

EXPERIMENTAL

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

Other: Ghostly app; Other: Blood flow restriction

Control

ACTIVE COMPARATOR

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.

Other: Leaflet

Interventions

Ghostly app 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; Ghostly

Blood flow restriction 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.

Blood flow restriction and Ghoslty

Leaflet 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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Unable to understand the instructions
• Other disabilities (muscular, orthopedic, …)
• Pregnancy
• Metal implants
• Implanted electrical devices
• Hospitalized
• + yrs
• or less repetitions on the 30 seconds sit-to-stand test
• Unable to understand the instructions
• Other disabilities (muscular, orthopedic, …)
• Metal implants
• Implanted electrical devices
• Hospitalized
• Recovering from COVID-19 or ICU patient
• score of 2 or less for manual muscle testing of the quadriceps muscle in both legs

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead
• Universitair Ziekenhuis Brussel: collaborator
• Revalidatieziekenhuis InkendaaI: collaborator

Study Sites (2)

Vrije Universiteit Brussel

Jette, Brussels Capital, 1090, Belgium

Location

University Hospital Brussels

Brussels, 1090, Belgium

Location

MeSH Terms

Conditions

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

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Muscular Atrophy; Atrophy; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Eva Swinnen, Prof. Ph.D

  Vrije Universiteit Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The Principal Investigator

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: February 28, 2022
• Study Start: July 1, 2023
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

BE (2)