Falls, Balance Self-confidenceNCT04430751
Medical Qigong for Mobility and Balance Self-Confidence
A study testing Medical QiGong training in people with Falls, Balance Self-confidence, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
The population is aging and increasingly at risk for falls and fractures with substantial consequences to wellbeing, health and costs. Training interventions such as Tai Chi have been demonstrated to help reduce these risks. Tai chi is a subset of both martial and medical qi gong. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Falls, Balance Self-confidence
- What is being tested?
- Medical QiGong training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2018to 15 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults 50 years of age or older who presented at the two study locations (Massachusetts, Arizona) were considered eligible for participation
Who cannot join
- Unable to participate in informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock medical Center
Lebanon, New Hampshire, 03756
About this study
The population is aging and increasingly at risk for falls and fractures with substantial consequences to wellbeing, health and costs. Training interventions such as Tai Chi have been demonstrated to help reduce these risks. Tai chi is a subset of both martial and medical qi gong.
This is a prospective intervention study with wait time control that will examine the ability of a manualized medical qi gong training protocol improve balance, gait and health self-confidence.
Read more
The intervention is a 12 week manualized medical qi gong training program where students are taught a progressive series of 10 qi gong forms that are designed to build upon each other and restore balance and function. These forms involve both physical movement and visualization.
The Community Balance and Mobility scale (a performance based measure) and Activities-specified Balance Confidence scale (a survey)will be the prime outcome instruments
- Conditions
- Falls, Balance Self-confidence
- Being tested
- Medical QiGong training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical QiGong trainingBehavioural
The study intervention consisted of a 12-week training program that introduced students to a progressive series of 10 QiGong "forms" that are designed to build upon each other to restore balance and function and to enhance well-being. These forms involve both physical movement and visualization.
| Study group | Role | What they receive |
|---|---|---|
| Immediate start | Active comparator | Not described Receives: Behavioral: Medical QiGong training |
| wait time control | Active comparator | Not described Receives: Behavioral: Medical QiGong training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Community Balance and Mobility Scale
Measured: through study completion, up to 16 weeks
Secondary outcomes (1)
Activities-specific Balance Confidence Scale
Measured: through study completion, up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start16 Mar 2018
- Primary completion15 Aug 2018
- Study completion15 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Falls, Balance Self-confidenceStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James E. Stahl, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04430751
- Sponsor's protocol ID
- 250-37
- Status last verified
- Jun 2020
- First submitted
- 10 Jun 2020
- Last updated
- 12 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: blinded de-identified information will be shared at request
Publications
Stahl JE, Belisle SS, Zhao W. Medical Qigong for Mobility and Balance Self-Confidence in Older Adults. Front Med (Lausanne). 2020 Aug 14;7:422. doi: 10.3389/fmed.2020.00422. eCollection 2020.
PubMed 32923446
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Qigong for Mobility and Balance Self-Confidence
- ClinicalTrials.gov ID
- NCT04430751
- Acronym / sponsor ID
- 250-37
- Conditions
- Falls, Balance Self-confidence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 16 Mar 2018 (actual)
- Primary completion
- 15 Aug 2018 (actual)
- Study completion
- 15 Aug 2018 (actual)
- First posted
- 12 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The population is aging and increasingly at risk for falls and fractures with substantial consequences to wellbeing, health and costs. Training interventions such as Tai Chi have been demonstrated to help reduce these risks. Tai chi is a subset of both martial and medical qi gong.
This is a prospective intervention study with wait time control that will examine the ability of a manualized medical qi gong training protocol improve balance, gait and health self-confidence.
The intervention is a 12 week manualized medical qi gong training program where students are taught a progressive series of 10 qi gong forms that are designed to build upon each other and restore balance and function. These forms involve both physical movement and visualization.
The Community Balance and Mobility scale (a performance based measure) and Activities-specified Balance Confidence scale (a survey)will be the prime outcome instruments
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate start | Active comparator | Behavioral: Medical QiGong training |
| wait time control | Active comparator | Behavioral: Medical QiGong training |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults 50 years of age or older who presented at the two study locations (Massachusetts, Arizona) were considered eligible for participation
Key exclusion criteria (1 listed)
- Unable to participate in informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical QiGong trainingThe study intervention consisted of a 12-week training program that introduced students to a progressive series of 10 QiGong "forms" that are designed to build upon each other to restore balance and function and to enhance well-being. These forms involve both physical movement and visualization. | Behavioural | Immediate start, wait time control |
Primary outcome
Community Balance and Mobility Scale
Time frame: through study completion, up to 16 weeks
1 secondary outcome
Activities-specific Balance Confidence Scale
Time frame: through study completion, up to 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2020.
- Derived from this study: PubMed 32923446Stahl JE, Belisle SS, Zhao W. Medical Qigong for Mobility and Balance Self-Confidence in Older Adults. Front Med (Lausanne). 2020 Aug 14;7:422. doi: 10.3389/fmed.2020.00422. eCollection 2020.
- Individual participant dataSharing planned: Yes. blinded de-identified information will be shared at request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical QiGong training in people with Falls, Balance Self-confidence, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Community Balance and Mobility Scale (time frame: through study completion, up to 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04430751, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2020.