NCT03333837 (IMOVE) is a NA clinical trial of Dance Group in Alzheimer's Disease (Incl Subtypes), sponsored by Wake Forest University Health Sciences.

Who is sponsoring NCT03333837?

NCT03333837 is sponsored by Wake Forest University Health Sciences.

What drugs are being tested in NCT03333837?

Interventions in NCT03333837: Dance Group, Non-Group Dance, Social Group, No Contact.

What condition does NCT03333837 study?

NCT03333837 studies Alzheimer's Disease (Incl Subtypes), Dementia, Mild Cognitive Impairment.

Is NCT03333837 still recruiting?

NCT03333837 is currently completed. Last updated 27 July 2022.

Are results published for NCT03333837?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-07-27 · How we verify

NCT03333837: IMOVE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Improvisational Movement for People With Memory Loss and Their Caregivers

Completed NA Results posted Last updated 27 July 2022

What this trial tests

NA trial testing Dance Group in Alzheimer's Disease (Incl Subtypes) in 104 participants. Completed in 26 May 2021.

Timeline

6 February 2018

Primary endpoint
26 May 2021

26 May 2021

Quick facts

Lead sponsor	Wake Forest University Health Sciences
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	104
Start date	6 February 2018
Primary completion	26 May 2021
Estimated completion	26 May 2021
Sites	1 location across United States

Drugs / interventions tested

Dance Group
Non-Group Dance
Social Group
No Contact

Conditions studied

Alzheimer's Disease (Incl Subtypes) — all drugs for Alzheimer's Disease (Incl Subtypes) →
Dementia — all drugs for Dementia →
Mild Cognitive Impairment — all drugs for Mild Cognitive Impairment →

Sponsor

Wake Forest University Health Sciences

Who can join

Adults 60 to 85, any sex, with Alzheimer's Disease (Incl Subtypes) or Dementia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Quality of Life in Alzheimer's Disease (QOL-AD)--Participants With Dementia (PWD) Primary · Baseline

Self-reported quality of life in the person with dementia is the primary outcome and will be measured using the QOL-AD . The QOL-AD is validated for use in people with Mini Mental State Exam scores as low as 10.The QOL\_AD contains 13 items.Points are assigned to each item as follows: poor = 1, fair = 2, good = 3, excellent = 4.The total score is the sum of all 13 item (range 13- 52) higher scores represent better outcomes.

Group	Value	95% CI
Dance Group	35.42	± 5.02
Non-group Dance	38.10	± 4.60
Social Group	35.56	± 4.15
No Contact	36.12	± 5.75

QOL-AD--PWD Primary · Week 12

Group	Value	95% CI
Dance Group	35.23	± 6.54
Non-group Dance	40.0	± 5.36
Social Group	36.68	± 4.76
No Contact	35.96	± 8.04

Community Structure--PWD Secondary · Baseline

This is a brain imaging variable derived from fMRI images. Modularity (Q) ranges from 0 (no community structure) to 1 (perfectly modular network). One Q-value is generated for each person and group averages are shown.

Group	Value	95% CI
Dance Group	.74	± .05
Non-group Dance	.72	± .05
Social Group	.73	± .05
No Contact	.74	± .04

Community Structure--PWD Secondary · Week 12

Group	Value	95% CI
Dance Group	.74	± .04
Non-group Dance	.73	± .05
Social Group	.75	± .04
No Contact	.75	± .03

Global Efficiency (eGlob)--PWD Secondary · Baseline

This is a brain imaging variable derived from fMRI images.Scale ranges from 0 (no long-range information processing) to 1 (maximal distributed processing). Decreased Eglob has been associated with aging, cognitive impairment, and depression.

Group	Value	95% CI
Dance Group	.19	± .02
Non-group Dance	.18	± .03
Social Group	.19	± .03
No Contact	.19	± .03

Global Efficiency (eGlob)--PWD Secondary · Week 12

Group	Value	95% CI
Dance Group	.19	± .03
Non-group Dance	.18	± .03
Social Group	.19	± .02
No Contact	.19	± .03

Local Efficiency (eLoc)--PWD Secondary · Baseline

Scale ranges from 0 (no local connectivity) to 1 (maximal local connectivity - all connections are local) and has been observed to change with cognitive impairment and depression.

Group	Value	95% CI
Dance Group	.59	± .03
Non-group Dance	.57	± .04
Social Group	.59	± .03
No Contact	.58	± .04

Local Efficiency (eLoc)--PWD Secondary · Week 12

Scale ranges from 0 (no local connectivity) to 1 (maximal local connectivity - all connections are local) and has been observed to change with cognitive impairment and depression.

Group	Value	95% CI
Dance Group	.58	± .03
Non-group Dance	.58	± .03
Social Group	.59	± .03
No Contact	.58	± .04

Path Length--PWD Secondary · Baseline

Refers to the number of edges that must be crossed to get from one node to another. Longer path length in people with AD has been associated with slower cognitive performance, beta amyloid deposition, and depression.

Group	Value	95% CI
Dance Group	5.29	± .58
Non-group Dance	5.69	± 1.17
Social Group	5.42	± .78
No Contact	5.52	± .93

Path Length--PWD Secondary · Week 12

Group	Value	95% CI
Dance Group	5.30	± .93
Non-group Dance	5.61	± .80
Social Group	5.36	± .54
No Contact	5.54	± 1.09

Fullerton Advanced Balance Scale (Overall Balance) PWD Secondary · Baseline

Fullerton Advanced Balance Scale (FAB) measures balance using 10 different performance-based tests (scored 0 worst - 4 best), including; standing with feet together and eyes closed, standing on a foam pad with eyes closed, walking while turning the head from side to side rhythmically, functional standing reach, turning around to the left and right, stepping up and over a 6-inch box, standing on one leg, and a test for postural reaction. The scale goes from 0-40 with 40 being the best outcome and a cutoff of \<=25 for risk of falls.

Group	Value	95% CI
Dance Group	23.71	± 8.22
Non-group Dance	27.88	± 5.40
Social Group	24.22	± 6.32
No Contact	26.79	± 4.57

Fullerton Advanced Balance Scale (Overall Balance) PWD Secondary · Week 12

Group	Value	95% CI
Dance Group	23.41	± 8.57
Non-group Dance	29.95	± 4.33
Social Group	24.27	± 6.26
No Contact	26.78	± 6.65

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline through Week 12. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Dance Group--PWD

Serious: 1/24 (4%)

Deaths: 0/24

Dance Group--Caregivers

Serious: 4/24 (17%)

Deaths: 0/24

Non-group Dance--PWD

Serious: 0/25 (0%)

Deaths: 0/25

Non-group Dance--Caregivers

Serious: 2/25 (8%)

Deaths: 0/25

Social Group--PWD

Serious: 2/27 (7%)

Deaths: 0/27

Social Group--Caregivers

Serious: 4/27 (15%)

Deaths: 0/27

No Contact--PWD

Serious: 4/25 (16%)

Deaths: 0/25

No Contact--Caregivers

Serious: 2/25 (8%)

Deaths: 0/25

Never Randomized-- PWD

Serious: 3/3 (100%)

Deaths: 1/3

Never Randomized--Caregiver

Serious: 1/3 (33%)

Deaths: 0/3

Serious adverse events (20 terms)

Reaction	System	Dance Group--PWD	Dance Group--Caregivers	Non-group Dance--PWD	Non-group Dance--Caregivers	Social Group--PWD	Social Group--Caregivers	No Contact--PWD	No Contact--Caregivers	Never Randomized-- PWD	Never Randomized--Caregiver
Heart attack	Cardiac disorders	—	—	—	—	—	—	—	—	—	—
Prostate cancer recurrence	Reproductive system and breast disorders	—	—	—	—	—	—	—	—	—	—
Elective full knee replacement	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Acute congestive heart failure	Cardiac disorders	—	—	—	—	—	—	—	—	—	—
Elevated blood pressure	Vascular disorders	—	—	—	—	—	—	—	—	—	—
Emergency room visit for shortness of breath	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—
Acute colitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Admitted to hospital for suicidal ideation	Psychiatric disorders	—	—	—	—	—	—	—	—	—	—
New diagnosis of non-small cell lung cancer	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—
Pain in hip due to sepsis	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Emergency room visit due to difficulty swallowing	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Fell walking across street and hit chest on sidewalk	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—
Emergency room visit for chest discomfort	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—
Accidentally given dilaudid in hospital	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—
Respiratory failure due to COVID	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—
Hit head falling backward getting out of bed	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Upper gastrointestinal bleed	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Numbness and lack of coordination in arm	Nervous system disorders	—	—	—	—	—	—	—	—	—	—
Complications and infection from hernia surgery	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—
Death (prior to randomization)	General disorders	—	—	—	—	—	—	—	—	—	—

Other adverse events (52 terms — click to expand)

Reaction	System	Dance Group--PWD	Dance Group--Caregivers	Non-group Dance--PWD	Non-group Dance--Caregivers	Social Group--PWD	Social Group--Caregivers	No Contact--PWD	No Contact--Caregivers	Never Randomized-- PWD	Never Randomized--Caregiver
Fall outside of study, no treatment needed	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Knee pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Foot pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Motor vehicle accident	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—
Abnormal lab results	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—
Sprained foot after fall (unrelated to study)	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Shoulder pain from arthritis	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Shingles	Nervous system disorders	—	—	—	—	—	—	—	—	—	—
Fall during data collection visit, no treatment needed	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Stumbled at home	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Leg pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Pulled muscle in lower back	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Chest pain due to gastrointestinal issue	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Discontinued atorvastatin	Product Issues	—	—	—	—	—	—	—	—	—	—
Knee and hip pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Urinary tract infection	Renal and urinary disorders	—	—	—	—	—	—	—	—	—	—
Toothache, swollen jaw	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Cellulitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Hip pain during intervention	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Low hemoglobin	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—
Side effects from donepezil	Product Issues	—	—	—	—	—	—	—	—	—	—
Chest pain and dizziness	Cardiac disorders	—	—	—	—	—	—	—	—	—	—
Slipped on wet pavement	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—
Leg cramps	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Exhaustion spell	General disorders	—	—	—	—	—	—	—	—	—	—
Broken ankle	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Respiratory infection	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—
Recurrent pneumonia	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—
Knee arthroscopy	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Diverticulitis flare	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Acute cystitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Aspiration of thyroid nodule	Surgical and medical procedures	—	—	—	—	—	—	—	—	—	—
Eye surgery	Eye disorders	—	—	—	—	—	—	—	—	—	—
Headache	General disorders	—	—	—	—	—	—	—	—	—	—
Incidental finding on MRI-space occupying lesion	General disorders	—	—	—	—	—	—	—	—	—	—
Acute gastritis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Ruptured patellar tendon	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Labored breathing and chest pain when bending over	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—
Tooth implants	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Heart attack, Prostate cancer recurrence, Elective full knee replacement, Acute congestive heart failure, Elevated blood pressure, Emergency room visit for shortness of breath, Acute colitis, Admitted to hospital for suicidal ideation.

Data from ClinicalTrials.gov NCT03333837 adverse events section.

Sponsor's own description

Dementia is a progressive decline in cognition that impairs a person's ability to perform activities of daily living. Changes in mood, gait, and balance are prominent secondary symptoms of Alzheimer's dementia that can dramatically decrease quality of life for the person with dementia and increase caregiver burden. The overall aim of this study is to determine the independent and combined effects of dance movement and social engagement on quality of life in people with early-stage dementia, and test the neural mechanisms of these effects.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Improvisational Movement to Improve Quality of Life in Older Adults With Early-Stage Dementia: A Pilot Study.
Thumuluri D, Lyday R, Babcock P, Ip EH, et al · · 2021 · cited 13× · PMID 35098120 · DOI 10.3389/fspor.2021.796101
Virtual delivery of improvisational movement and social engagement interventions in the IMOVE trial during the COVID-19 pandemic.
Fanning JT, Barnstaple R, Babcock P, Black A, et al · · 2023 · cited 4× · PMID 36969988 · DOI 10.1016/j.conctc.2023.101102
IMOVE: Protocol for a randomized, controlled 2x2 factorial trial of improvisational movement and social engagement interventions in older adults with early Alzheimer's disease.
Hugenschmidt CE, Ip EH, Laurita-Spanglet J, Babcock P, et al · · 2023 · PMID 36949846 · DOI 10.1016/j.conctc.2023.101073

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03333837 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Wake Forest University Health Sciences
Last refreshed: 27 July 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03333837.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT03333837: IMOVE

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (20 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Alzheimer's Disease (Incl Subtypes)

Other Wake Forest University Health Sciences trials

Verify against primary sources