NCT03517371: WHIPPD

Walking and mHealth to Increase Participation in Parkinson Disease

Completed NA Results posted Last updated 26 March 2025

What this trial tests

NA trial testing mHealth delivered exercise program in Parkinson Disease in 140 participants. Completed in 6 March 2024.

Timeline

4 February 2019

Primary endpoint
6 March 2024

6 March 2024

Quick facts

Lead sponsor	Boston University Charles River Campus
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	140
Start date	4 February 2019
Primary completion	6 March 2024
Estimated completion	6 March 2024
Sites	2 locations across United States

Drugs / interventions tested

• mHealth delivered exercise program
• Exercise only

Conditions studied

• Parkinson Disease — all drugs for Parkinson Disease →

Sponsor

Boston University Charles River Campus

Who can join

18 and older, any sex, with Parkinson Disease. 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.

Walking Activity Primary · 12 months

Change in the average number of steps walked per day over the one year study. Participants wore the step watch for one week before starting the program as part of their baseline visit and one week at the end of the year program as part of their 12-month visit. Daily steps were averaged at baseline and 12-month and a change score was computed (average of daily steps at 12-Months minus average of daily steps at baseline).

Group	Value	95% CI
mHealth Delivered Exercise Program	-207.59	± 2749.39
Exercise Only	-135.24	± 2403.17

Walking Intensity Primary · 12 months

Change in the average number of moderate intensity minutes over the one year study. Moderate intensity minutes is defined as the number of minutes in which \>100 steps were accumulated. Participants wore the step watch for one week before starting the program as part of their baseline visit and one week at the end of the year program as part of their 12-month visit. Moderate intensity minutes were averaged at baseline and 12-month and a change score was computed (average of moderate intensity minutes at 12-Months minus average of moderate intensity minutes at baseline).

Group	Value	95% CI
mHealth Delivered Exercise Program	1.67	± 9.41
Exercise Only	1.33	± 8.07

Walking Capacity - Six Minute Walk Distance Secondary · 12 months

Change in the number of meters walked during the six-minute walk test over the one year study. The distance in meters is reported. Participants completed the six-minute walk before starting the program as part of their baseline visit and at the end of the year program as part of their 12-month visit. A change score was computed - the number of meters walked at 12 months minus the number of meters walked at baseline).

Group	Value	95% CI
mHealth Delivered Exercise Program	15.63	± 57.02
Exercise Only	17.79	± 37.12

Walking Capacity - Ten Meter Walk Test Secondary · 12 months

Change in the number of meters per second walked during the ten-meter walk test (comfortable forward pace) over the one year study. The distance in meters per second are reported. Participants completed the ten-meter walk test before starting the program as part of their baseline visit and at the end of the year program as part of their 12-month visit. A change score was computed - the number of meters per second walked at 12-months minus the number of meters per second walked at baseline).

Group	Value	95% CI
mHealth Delivered Exercise Program	.027	± .146
Exercise Only	.019	± .154

Adverse events — posted to ClinicalTrials.gov

Time frame: Information about adverse events were collected from active participants - either until they withdrew or completed the one-year study.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

mHealth Delivered Exercise Program

Serious: 15/73 (21%)

Deaths: 0/73

Exercise Only

Serious: 17/67 (25%)

Deaths: 0/67

Serious adverse events (19 terms)

Reaction	System	mHealth Delivered Exercise…	Exercise Only
Fall	Injury, poisoning and procedural complications	—	—
Pain in Extremity	Musculoskeletal and connective tissue disorders	—	—
Generalized Muscle Weakness	Musculoskeletal and connective tissue disorders	—	—
Retinal Detachment	Eye disorders	—	—
Esophageal Spasm	Gastrointestinal disorders	—	—
Gait Disturbance	General disorders	—	—
Gallbladder Pain	Hepatobiliary disorders	—	—
Urinary Tract Infection	Infections and infestations	—	—
Renal Calculi	Renal and urinary disorders	—	—
Voice Alteration	Respiratory, thoracic and mediastinal disorders	—	—
Skin Ulceration	Skin and subcutaneous tissue disorders	—	—
Hypotension	Vascular disorders	—	—
Cognitive Disturbance	Nervous system disorders	—	—
Dysarthria	Nervous system disorders	—	—
Neoplasm - Salivary Gland	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Neoplasm - Ovarian	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Device Related Infection	Infections and infestations	—	—
Lower Gastrointestinal Bleeding	Gastrointestinal disorders	—	—
Myocardial Infection	Cardiac disorders	—	—

Other adverse events (3 terms — click to expand)

Reaction	System	mHealth Delivered Exercise…	Exercise Only
Pain in Extremity	Musculoskeletal and connective tissue disorders	—	—
Fall	Injury, poisoning and procedural complications	—	—
Back Pain	Musculoskeletal and connective tissue disorders	—	—

Most-reported serious reactions: Fall, Pain in Extremity, Generalized Muscle Weakness, Retinal Detachment, Esophageal Spasm, Gait Disturbance, Gallbladder Pain, Urinary Tract Infection.

Data from ClinicalTrials.gov NCT03517371 adverse events section.

Sponsor's own description

Identifying effective ways to improve function, slow decline and reduce disability is a high priority for people living with Parkinson disease and other chronic conditions. Regular participation in walking is essential to reduce disability and enhance participation in preferred life activities. However, people with chronic conditions are often sedentary, contributing to greater disability. The goal of this work is to determine the benefits of a walking, walking enhancing exercises and cognitive-behavioral strategies delivered using mobile health technology for people with Parkinson disease over a sustained period of time.

Publications & conference data

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

1. Design of the WHIP-PD study: a phase II, twelve-month, dual-site, randomized controlled trial evaluating the effects of a cognitive-behavioral approach for promoting enhanced walking activity using mobile health technology in people with Parkinson-disease.
   Rawson KS, Cavanaugh JT, Colon-Semenza C, DeAngelis T, et al · · 2020 · cited 11× · PMID 32312243 · DOI 10.1186/s12883-020-01718-z
2. Does clinically measured walking capacity contribute to real-world walking performance in Parkinson's disease?
   Zajac JA, Cavanaugh JT, Baker T, Duncan RP, et al · · 2022 · cited 8× · PMID 36423521 · DOI 10.1016/j.parkreldis.2022.11.016
3. Natural Walking Intensity in Persons With Parkinson Disease.
   Girnis JL, Cavanaugh JT, Baker TC, Duncan RP, et al · · 2023 · cited 5× · PMID 37016469 · DOI 10.1097/npt.0000000000000440
4. Clinical Trial Highlights - Interventions Promoting Physical Activity in Parkinson's Disease.
   Oosterhof TH, Schootemeijer S, de Vries NM. · · 2023 · cited 4× · PMID 37125564 · DOI 10.3233/jpd-239001
5. Are Mobile Persons With Parkinson Disease Necessarily More Active?
   Zajac JA, Cavanaugh JT, Baker T, Colón-Semenza C, et al · · 2021 · cited 4× · PMID 34091569 · DOI 10.1097/npt.0000000000000362
6. Factors influencing activity performance and participation in usual life situations among people with Parkinson's disease: a mixed methods study.
   Paul SS, Porciuncula F, Cavanaugh JT, Dennis S, et al · · 2026 · PMID 41267477 · DOI 10.1080/09638288.2025.2589718