Last reviewed · How we verify
Mindful Movement for Physical Activity and Wellbeing in Older Adults- A Hybrid Effectiveness-Implementation Study
NA trial testing Mindful Movement in Physical Inactivty in 176 participants. Completed in 31 March 2022.
| Lead sponsor | University of Minnesota |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | other |
| Enrollment | 176 |
| Start date | 17 July 2019 |
| Primary completion | 31 March 2022 |
| Estimated completion | 31 March 2022 |
| Sites | 5 locations across United States |
University of Minnesota
50 and older, any sex, with Physical Inactivty or Wellbeing. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Minutes/week spent in ≥10-min bouts of MVPA
| Group | Value | 95% CI |
|---|---|---|
| Mindful Movement | 18.35 | ± 24.97 |
| Keys to Health & Wellbeing | 15.54 | ± 23.94 |
Minutes/week spent in ≥10-min bouts of MVPA
| Group | Value | 95% CI |
|---|---|---|
| Mindful Movement | 39.5 | 24.5 – 57.5 |
| Keys to Health & Wellbeing | 24.3 | 12.6 – 35.7 |
Minutes/week spent in ≥10-min bouts of MVPA
| Group | Value | 95% CI |
|---|---|---|
| Mindful Movement | 28.0 | 14.5 – 44.0 |
| Keys to Health & Wellbeing | 16.2 | 8.4 – 24.9 |
Minutes/week spent in ≥10-min bouts of MVPA
| Group | Value | 95% CI |
|---|---|---|
| Mindful Movement | 20.7 | 10.7 – 32.5 |
| Keys to Health & Wellbeing | 11.3 | 3.4 – 20.4 |
Minutes/week spent in MVPA
| Group | Value | 95% CI |
|---|---|---|
| Mindful Movement | 91.9 | ± 74.3 |
| Keys to Health & Wellbeing | 93.0 | ± 95.2 |
Minutes/week spent in MVPA
| Group | Value | 95% CI |
|---|---|---|
| Mindful Movement | 49.2 | 29.0 – 69.4 |
| Keys to Health & Wellbeing | 34.4 | 14.5 – 54.3 |
Minutes/week spent in MVPA
| Group | Value | 95% CI |
|---|---|---|
| Mindful Movement | 43.0 | 23.4 – 62.7 |
| Keys to Health & Wellbeing | 23.1 | 3.8 – 42.5 |
Minutes/week spent in MVPA
| Group | Value | 95% CI |
|---|---|---|
| Mindful Movement | 20.6 | 1.0 – 40.2 |
| Keys to Health & Wellbeing | 8.8 | -10.5 – 28.0 |
Time spent in sedentary activity
| Group | Value | 95% CI |
|---|---|---|
| Mindful Movement | 2804 | ± 912 |
| Keys to Health & Wellbeing | 2988 | ± 1069 |
Time spent in sedentary activity
| Group | Value | 95% CI |
|---|---|---|
| Mindful Movement | -85 | -256 – 85 |
| Keys to Health & Wellbeing | -46 | -214 – 123 |
Time spent in sedentary activity
| Group | Value | 95% CI |
|---|---|---|
| Mindful Movement | -246 | -432 – -60 |
| Keys to Health & Wellbeing | -209 | -392 – -26 |
Time spent in sedentary activity
| Group | Value | 95% CI |
|---|---|---|
| Mindful Movement | 51 | -137 – 238 |
| Keys to Health & Wellbeing | 153 | -31 – 336 |
Time frame: Adverse events were collected over the 1 year trial period.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Mindful Movement | Keys to Health & Wellbeing |
|---|---|---|---|
| Cardiac conditions (e.g., atrial fibrillation, heart failure) | Cardiac disorders | — | — |
| Hospitalization: Fracture or Dislocation | Musculoskeletal and connective tissue disorders | — | — |
| Hospitalization: Pseudosepsis | Vascular disorders | — | — |
| Hospitalization: Infection (COVID-19 or other) | Infections and infestations | — | — |
| Stroke | Vascular disorders | — | — |
| Hospitalization: Renal or Urinary disease | Renal and urinary disorders | — | — |
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Hospitalization: Joint Replacement | Musculoskeletal and connective tissue disorders | — | — |
| Hospitalization: Vertigo or Syncope | Nervous system disorders | — | — |
| Amyloidosis | Metabolism and nutrition disorders | — | — |
| Reaction | System | Mindful Movement | Keys to Health & Wellbeing |
|---|---|---|---|
| Increased pain | Musculoskeletal and connective tissue disorders | — | — |
| Increased sadness, anxiousness, loneliness, or disturbing memories | Psychiatric disorders | — | — |
| Infection (COVID-19 or other) | Infections and infestations | — | — |
| Increased fatigue | General disorders | — | — |
| Vertigo or Syncope | Nervous system disorders | — | — |
Most-reported serious reactions: Cardiac conditions (e.g., atrial fibrillation, heart failure), Hospitalization: Fracture or Dislocation, Hospitalization: Pseudosepsis, Hospitalization: Infection (COVID-19 or other), Stroke, Hospitalization: Renal or Urinary disease, Cancer, Hospitalization: Joint Replacement.
Data from ClinicalTrials.gov NCT03929393 adverse events section.
Physical inactivity has reached pandemic proportions and is associated with increased morbidity, mortality, and healthcare costs. Of particular concern is that most middle to older age adults fall far short of recommendations for health enhancing physical activities. This research takes a novel approach to tackling this problem by combining mindfulness with behavioral strategies in a unique 'Mindful Movement' program offered collaboratively with the YMCA.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
Trials testing the same drug.
Currently open trials in the same condition.
Trials by the same sponsor.
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/NCT03929393.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing